Antibiotic strategies for eradicating Pseudomonas aeruginosa in people with cystic fibrosis

Cochrane Database of Systematic Reviews

Volumn 2017, Issue 4, 2017, Pages

  Langton Hewer, Simon C ^a   Smyth, Alan R ^b  

^a BRISTOL ROYAL HOSPITAL FOR CHILDREN   (United Kingdom)

^b UNIVERSITY OF NOTTINGHAM   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIBIOTIC AGENT; CIPROFLOXACIN; COLISTIN; PLACEBO; TOBRAMYCIN; ANTIINFECTIVE AGENT;

ADULT; ADVERSE DRUG REACTION; ANTIBIOTIC THERAPY; BACTERIUM ISOLATION; CHILD; COCHRANE LIBRARY; COST; COST EFFECTIVENESS ANALYSIS; CROSSOVER PROCEDURE; CYSTIC FIBROSIS; DISEASE CLEARANCE; DISEASE EXACERBATION; ERADICATION THERAPY; GROWTH; HUMAN; INFECTION; INFORMATION RETRIEVAL; LUNG INFECTION; MORTALITY; NUTRITIONAL STATUS; OUTCOME ASSESSMENT; PRIORITY JOURNAL; PSEUDOMONAS INFECTION; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; RISK ASSESSMENT; SPIROMETRY; SPUTUM CULTURE; SYSTEMATIC REVIEW; COMPLICATION; INHALATIONAL DRUG ADMINISTRATION; META ANALYSIS; MICROBIOLOGY; ORAL DRUG ADMINISTRATION; PSEUDOMONAS AERUGINOSA; PSEUDOMONAS INFECTIONS; RESPIRATORY SYSTEM;

ADMINISTRATION, INHALATION; ADMINISTRATION, ORAL; ADULT; ANTI-BACTERIAL AGENTS; CHILD; CIPROFLOXACIN; COLISTIN; CYSTIC FIBROSIS; HUMANS; PSEUDOMONAS AERUGINOSA; PSEUDOMONAS INFECTIONS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESPIRATORY SYSTEM; TOBRAMYCIN;

EID: 85018646181     PISSN: None     EISSN: 1469493X     Source Type: Journal    
DOI: 10.1002/14651858.CD004197.pub5     Document Type: Review

References (275)

1. Gibson RL, Emerson J, McNamara S, Burns JL, Rosenfeld M, Yunker A, et al. A randomized, controlled trial of inhaled tobramycin in young children with cystic fibrosis: Eradication of pseudomonas from the lower airway. Pediatric Pulmonology 2002;Suppl 24:300. [CFGD Register: PI151c]2863220
2. Gibson RL, Emerson J, McNamara S, Burns JL, Rosenfeld M, Yunker A, et al. Online Supplement to 'Significant microbiological effect of inhaled tobramycin in young children with cystic fibrosis'. [online]. American Journal of Respiratory and Critical Care Medicine 2003;167(6):841 Online. [CFGD Register: PI151e]2863221
3. Gibson RL, Emerson J, McNamara S, Burns JL, Rosenfeld M, Yunker A, et al. Significant microbiological effect of inhaled tobramycin in young children with cystic fibrosis. American Journal of Respiratory and Critical Care Medicine 2003;167(6):841-9. [CFGD Register: PI151d]2863222
4. Rosenfeld M. Serum and lower respiratory tract tobramycin concentrations produced by inhaled tobramycin (TOBI) in young children with cystic fibrosis. Pediatric Pulmonology 1999;Suppl 19:106-8. [CFGD Register: PI151b]2863224
5. Rosenfeld M, Borowitz D, Emerson J, Gibson R, McCoy K, McNamara S, et al. Serum pharmacokinetics and safety of inhaled tobramycin in very young CF patients. Pediatric Pulmonology 1999;Suppl 19:262. [CFGD Register: PI151a]2863223
6. Proesmans M, Boulanger L, Vermeulen F, De Boeck K. Eradication of recent Pseudomonas aeruginosa isolation: TOBI versus colistin/ciprofloxacin. Journal of Cystic Fibrosis 2008;7(S2):S64. [CFGD Register: PI208a]2863226
7. Proesmans M, Boulanger L, Vermeulen F, De Boeck K. Eradication of recent Pseudomonas aeruginosa isolation: TOBI versus colistin/ciprofloxacin. Pediatric Pulmonology 2009;44(S32):321. [Abstract no: 311; CFGD Register: PI208b; MEDLINE: 96296083]2863227
8. Proesmans M, Boulanger L, Vermeulen F, De Boeck K. Eradication of recent pseudomonas aeruginosa infection: TOBI versus Colistineb®/ ciprofloxacin. Journal of Cystic Fibrosis 2011;10 Suppl 1:S26. [Abstract no: 102; CFGD Register: PI208c]2863228
9. Proesmans M, Vermeulen F, Boulanger L, Verhaegen J, De Boeck K. Comparison of two treatment regimens for eradication of Pseudomonas aeruginosa infection in children with cystic fibrosis. Journal of Cystic Fibrosis 2013;12(1):29-34. [CFGD Register: PI208d]2863229
10. Ratjen F, Munck A, Campello V. Inhaled tobramycin nebuliser solution for treatment of early Pseudomonas aeruginosa infection: first results from the Elite study. Pediatric Pulmonlogy 2006;41(S29):318. [CFGD Register: PI197b]2863231
11. Ratjen F, Munck A, Campello V. Safety of inhaled tobramycin nebuliser solution for treatment of early pseudomonas aeruginosa infection: first results from the ELITE study. Journal of Cystic Fibrosis 2006;5 Suppl 1:S22. [CFGD Register: PI197a]2863232
12. Ratjen F, Munck A, Kho P. Short and long-term efficacy of inhaled tobramycin in early P. Aeruginosa infection: the ELITE study. Pediatric Pulmonology 2008;43(S31):319. [CFGD Register: PI197d]2863234
13. Ratjen F, Munck A, Kho P, Angyalosi G, for the ELITE Study Group. Treatment of early Pseudomonas aeruginosa infection in patients with cystic fibrosis: the ELITE trial. Thorax 2010;65(4):286-91. [CFGD Register: PI197e]2863233
14. Ratjen F, Stenglein S, Munck A. Inhaled tobramycin nebulizer solution for treatment of early Pseudomonas aeruginosa infection; the ELITE study. Journal of Cystic Fibrosis 2008;7 Suppl 2:S26. [CFGD Register: PI197c]2863235
15. Cariani L, Defilippi G, Costantini D, Claut L, Clarizia G, D'accico M, et al. Semi-automated rep-pcr genotyping of pseudomonas aeruginosa in Italian CF patients in eradication therapy. Pediatric Pulmonology 2010;45 Suppl 33:348. [Abstract no: 360; CFGD Register: PI230c]2863237
16. Dolce D, Cariani L, Ravenni N, Mergni G, Biffi A, Colombo C, et al. Anti-P.aeruginosa antibodies and microbiological outcome in patients treated with early eradication therapy. Pediatric Pulmonology 2013;48 Suppl 36:288. [Abstract no: 231; CENTRAL: 921692; CFGD Register: PI230i; CRS: 5500125000000403]2863238
17. Taccetti G, Bianchini E, Zavataro L, Campana S, Defilippi G, Ravenni N, et al. Pseudomonas aeruginosa eradication in cystic fibrosis: preliminary data from a randomized multicenter study of two different early antibiotic treatment protocols. Pediatric Pulmonology 2010;45(S33):337. [Abstract no: 332; CFGD Register: PI230d]2863239
18. Taccetti G, Bianchini E, Zavataro L, Campana S, Defilippi G, Ravenni N, et al. Pseudomonas aeruginosa microbiological status and emergence of other pathogens after early eradication treatment in cystic fibrosis: a post-trial follow-up. Pediatric Pulmonology 2011;46(S34):317. [Abstract no: 292; CFGD Register: PI230e]2863240
19. Taccetti G, Bianchini E, Zavataro L, Campana S, Ravenni N, Boni V, et al. Early antibiotic treatment for Pseudomonas aeruginosa eradication in cystic fibrosis patients: a randomized multicenter study of two different protocols. Pediatric Pulmonology 2009;44(S32):354. [Abstract no: 406; CFGD CF Register: PI230a; MEDLINE: 96296083]2863241
20. Taccetti G, Bianchini E, Zavataro L, Costantini D, Galici V, Campana S, et al. Pseudomonas aeruginosa eradication in cystic fibrosis: final results of a randomized multicenter study of two different early antibiotic treatment protocols. Pediatric Pulmonology 2011;46(S34):317. [Abstract no: 291; CFGD Register: PI230f]2863242
21. Taccetti G, Cocchi P, Dolce D, Galici V, Mergni G, Gagliardini R, et al. Is early eradication treatment against P.aeruginosa associated with the emergence of other non-fermenter gram negatives. Pediatric Pulmonology 2013;48 Suppl 36:328. [Abstract no: 338; CENTRAL: 921671; CFGD Register: PI230h; CRS: 5500125000000398]2863243
22. Taccetti G, Bianchini E, Cariani L, Buzzetti R, Costantini D, Trevisan F, et al. Early antibiotic treatment for Pseudomonas aeruginosa eradication in patients with cystic fibrosis: a randomised multicentre study comparing two different protocols. Thorax 2012;67(10):853-9. [CFGD Register: PI230g]2863244
23. Zavataro L, Taccetti G, Cariani L, Ravenni N, Braccini G, Bresci S, et al. Epidemiology of first/new Pseudomonas aeruginosa infection in cystic fibrosis patients. Journal of Cystic Fibrosis 2010;9 Suppl 1:S29. [Abstract no: 110; CFGD Register: PI230b]2863245
24. Anstead M, Heltshe SL, Khan U, Barbieri JT, Langkamp M, Doring G, et al. Pseudomonas aeruginosa serology and risk for re-isolation in the EPIC trial. Journal of Cystic Fibrosis 2013;12(2):147-53. [CENTRAL: 1089772; CFGD Register: PI202m; CRS: 5500135000000084; PUBMED: 22944725]5462862
25. Anstead M, Lymp J, Khan U, Barbieri J, Langkamp M, Doring G, et al. Pseudomonas aeruginosa serology predicts response to treatment and re-infection in the EPIC clinical study. Pediatric Pulmonology 2011;46(S34):303. [Abstract no: 254; CFGD Register: PI202g]2863247
26. Hamblett NM, Retsch-Bogart GZ, Treggiari M, Kronmal RA, Khan U, Williams J, et al. Safety and efficacy of anti-pseudomonal therapy for early eradication of Pseudomonas aeruginosa: the EPIC study. Pediatric Pulmonology 2009;44(S32):183. [CFGD CF Register: PI202b; MEDLINE: 96296083]2863248
27. Hoffman LR, Ramsey BW, Kulasekara HD, Retsch-Bogart GZ, Wolter DJ, Pope CE, et al. Pseudomonas aeruginosa (PA) phenotypes associated with persistent early infection in CF patients in the EPIC Clinical Trial. Pediatric Pulmonology 2012;47(S35):317. [Abstract no: 266; CFGD Register: PI202j]2863249
28. Jorth P, Hisert KB, Garudathri J, Wolter D, Hoffman L, Singh P. Studies on the effects of ciprofloxacin on pseudomonas aeruginosa evolution in cystic fibrosis patients. Pediatric Pulmonology 2014;49:349. [CENTRAL: 1057036; CFGD Register: PI202n; CRS: 5500050000000261; EMBASE: 71616423]5462863
29. Jorth P, Rezayat A, Hisert KB, Garudathri J, Khan U, Hamblett NM, et al. Early evolution of pseudomonas aeruginosa during cystic fibrosis infection [abstract]. Pediatric Pulmonology 2015;50 Suppl 41:304, Abstract no: 300. [CENTRAL: 1092204; CFGD Register: PI202p; CRS: 5500135000001393]5462864
30. Khan U, Mayer-Hamblett N, Retsch-Bogart G, Treggiari M, Ramsey B. Association between baseline pseudomonas aeruginosa positivity in EPIC clinical trial participants & prior antibiotic exposure. Pediatric Pulmonology 2010;45(S33):335. [Abstract no: 326; CFGD Register: PI202f]2863250
31. Mayer-Hamblett N, Kloster M, Rosenfeld M, Gibson RL, Retsch-Bogart GZ, Emerson J, et al. Impact of Sustained Eradication of New Pseudomonas aeruginosa Infection on Long-term Outcomes in Cystic Fibrosis. Clinical Infectious Diseases 2015;61(5):707-15. [CENTRAL: 1099084; CFGD Register: PI202o; CRS: 5500135000001411; PUBMED: 25972024]5462865
32. Mayer-Hamblett N, Kronmal RA, Gibson RL, Rosenfeld M, Retsch-Bogart G, Treggiari MM, et al. Initial Pseudomonas aeruginosa treatment failure is associated with exacerbations in cystic fibrosis. Pediatric Pulmonology 2012;47(2):125-34. [CFGD Register: PI202i; DOI: 10.1002/ppul.21525]2863251
33. Mayer-Hamblett N, Rosenfeld M, Treggiari MM, Konstan MW, Retsch-Bogart G, Morgan W, et al. Standard care versus protocol based therapy for new onset Pseudomonas aeruginosa in cystic fibrosis. Pediatric Pulmonology 2013;48(10):943-53. [CENTRAL: 916577; CFGD Register: PI202k; CRS: 5500125000000727; PUBMED: 23818295]2863252
34. Ramsey B. TOBI use in infants and children with early Pseudomonas Aeruginosa infection - duration of effect and epic update. Pediatric Pulmonology 2005;40(S28):146. [CFGD CF Register: PI202a]2863253
35. Treggiari M, Retsch-Bogart G, Mayer-Hamblett N, Khan U, Kronmal R, Ramsey B, et al. Comparative efficacy and safety of four randomized regimens to treat early Pseudomonas aeruginosa infection in children with cystic fibrosis. Journal of Cystic Fibrosis 2010;9 Suppl 1:S54. [Abstract no: 209; CFGD Register: PI202e]2863254
36. Treggiari M, Retsch-Bogart GZ, Mayer-Hamblett N, Kronmal R, Khan U, Williams J, et al. Early anti-pseudomonal infection in children with CF: study population and conduct of the ;EPIC; clinical trial [abstract]. Pediatric Pulmonology 2009;44(S32):316, Abstract no: 299. [CFGD CF Register: PI202c; MEDLINE: 96296083]2863255
37. Treggiari MM, Retsch-Bogart G, Mayer-Hamblett N, Khan U, Kulich M, Kronmal R, et al. Comparative efficacy and safety of 4 randomized regimens to treat early Pseudomonas aeruginosa infection in children with cystic fibrosis. Archives of Pediatrics and Adolescent Medicine 2011;165(9):847-56. [CFGD Register: PI202h]2863256
38. Treggiari MM, Rosenfeld M, Mayer-Hamblett N, Retsch-Bogart G, Gibson RL, Williams J, et al. Early anti-pseudomonal acquisition in young patients with cystic fibrosis: rationale and design of the EPIC clinical trial and observational study. Contempory Clinical Trials 2009;30(3):256-68. [CFGD CF Register: PI202d; MEDLINE: 96296083]2863257
39. Valerius NH, Koch C, Høiby N. Prevention of chronic Pseudomonas aeruginosa colonisation in cystic fibrosis by early treatment. Lancet 1991;338(8769):725-6. [CFGD Register: PI70b]2863259
40. Valerius NH, Koch C, Høiby N. Prevention of chronic colonization with Pseudomonas aeruginosa in patients with CF by early treatment with ciprofloxacin and colistin aerosol inhalations. Pediatric Pulmonology 1990;9(Supplement S5):248. [CFGD Register: PI70a]2863260
41. Ratjen F, Steinkamp G, Döring G, Bauernfeind A, Wiesemann HG, Von Der Hardt H. Prevention of chronic pseudomonas aeruginosa infection by early inhalation therapy with tobramycin. Pediatric Pulmonology 1994;Suppl 10:250. [CFGD Register: PI101a]2863262
42. Wiesemann HG, Steinkamp G, Ratjen F, Baurnfeind A, Przyklenk B, Döring G, et al. Placebo-controlled, double-blind, randomised study of aerosolised tobramycin for early treatment of Pseudomonas aeruginosa colonization in cystic fibrosis. Pediatric Pulmonology 1998;25(2):88-92. [CFGD Register: PI101b]2863263
43. Alothman GA, Alsaadi MM, Ho BL, Ho SL, Dupuis A, Corey M, et al. Evaluation of bronchial constriction in children with cystic fibrosis after inhaling two different preparations of tobramycin. Chest 2002;122(3):930-4. [CENTRAL: 398028; CFGD Register: PI157b; CRS: 5500100000002196; PUBMED: 12226034]2863265
44. Alothman GA, Coates AL, Corey M, Dupuis A, Ho SL, Ho BL, et al. In cystic fibrosis (CF) patients, does the inhalation of an intravenous tobramycin preparation result in more bronchospasm than a preservative free tobramycin preparation?. Pediatric Pulmonology 2000;Suppl 20:298-9. [CFGD Register: PI157a]2863266
45. Alothman GA, Ho B, Alsaadi MM, Ho SL, O'Drowsky L, Louca E, et al. Bronchial constriction and inhaled colistin in cystic fibrosis. Chest 2005;127(2):522-9. [CENTRAL: 502709; CFGD Register: PI190; CRS: 5500100000002670; PUBMED: 15705991]2863268
46. Ballman M, Rabsch P, von der Hardt H. Long term follow up of changes in FEV1 and treatment intensity during Pseudomonas aeruginosa colonisation in patients with cystic fibrosis. Thorax 1998;53(9):732-7. 2863270
47. Brett MM, Simmonds EJ, Ghonheim ATM, Littlewood JM. The value of serum IgG titres against Pseudomonas aeruginosa in the management of early infection in cystic fibrosis. Archives of Disease in Childhood 1992;67(9):1086-8. [CFGD Register: PI73]2863272
48. Church DA, Kanga JF, Kuhn RJ, Rubio TT, Spohn WA, Stevens JC, et al. Sequential ciprofloxacin therapy in pediatric cystic fibrosis: comparative study vs. ceftazidime/tobramycin in the treatment of acute pulmonary exacerbations. The Cystic Fibrosis Study Group. Pediatric Infectious Disease Journal 1997;16(1):97-105. [CENTRAL: 135891; CFGD Register: PI115; CRS: 5500100000000803; PUBMED: 9002118]2863274
49. Clancy JP, Dupont L, Konstan MW, Billings J, Fustik S, Goss CH, et al. Online supplementary data to ;Phase II studies of nebulised Arikace in CF patients with Pseudomonas aeruginosa infection; [online. Thorax 2013;68(9):818-25 online. [CFGD Register: PI207f // PI222d ; CRS: 5500135000000003]5462866
50. Clancy JP, Dupont L, Konstan MW, Billings J, Fustik S, Goss CH, et al. Phase II studies of nebulised Arikace in CF patients with Pseudomonas aeruginosa infection. Thorax 2013;68(9):818-25. [CENTRAL: 876398; CFGD Register: PI207e // PI222c ; CRS: 5500050000000084; PUBMED: 23749840]2863276
51. Clancy JP, Minic P, Dupont L, Goss CH, Quittner AL, Lymp JF, et al. Full analysis of data from two phase II blinded & placebo-controlled studies of nebulized liposomal amikacin for inhalation (Arikace) in the treatment of CF patients with pseudomonas aeruginosa lung infection. Pediatric Pulmonology 2010;45 Suppl 33:299. [Abstract no: 227; CENTRAL: 848916; CFGD Register: PI207d // PI222b; CRS: 5500100000010628]2863277
52. Dupont L, Minic P, Fustic S, Mazurek H, Solyom E, Feketova A, et al. A randomised placebo-controlled study of nebulized liposomal amikacin (Arikace) in the treatment of cystic fibrosis patients with chronic Pseudomonas aeruginosa lung infection. Journal of Cystic Fibrosis 2008;7 Suppl 2:S26. [CENTRAL: 790820; CFGD Register: PI207a; CRS: 5500100000003531]2863278
53. Dupont LJ, Minic P, Fustik S, Mazurek H, Solyom E, Feketeova A, et al. A randomized placebo-controlled study of nebulized liposomal amikacin (Arikace) in the treatment of cystic fibrosis patients with chronic Pseudomonas Aeruginosa lung infection. Pediatric Pulmonology 2008;43 Suppl 31:301. [CENTRAL: 790939; CFGD Register: PI207b; CRS: 5500100000003535]2863279
54. Gupta R, Dupont L, Minin P, Fustik S, Mazurek H, Solyom E, et al. A randomized placebo-controlled study of nebulized liposomal amikacin (Arikace) in the treatment of cystic fibrosis patients with chronic Pseudomonas aeruginosa lung infection (protocol TR02-105). American Journal of Respiratory and Critical Care Medicine 2009;179. [Abstract no: A1199; CENTRAL: 790940; CFGD Register: PI207c; CRS: 5500100000003536]2863280
55. Coates AL, Denk O, Leung K, Ribeiro N, Chan J, Green M, et al. Higher tobramycin concentration and vibrating mesh technology can shorten antibiotic treatment time in cystic fibrosis. Pediatric Pulmonology 2011;46(4):401-8. [CENTRAL: 786190; CFGD Register: PI241b; CRS: 5500100000006333]2863282
56. Denk O, Caotes AL, Keller M, Leung K, Green M, Chan J, et al. Lung delivery of a new tobramycin nebuliser solution (150mg/1.5ml) by an investigational eFlow® nebuliser is equivalent to TOBI® but in a fraction of time. Journal of Cystic Fibrosis 2009;8 Suppl 2:S66. [Abstract no: 264; CENTRAL: 794467; CFGD Register: PI241c; CRS: 5500100000003576]2863283
57. Keller M, Coates AL, Griese M, Denk O, Schierholz J, Knoch M. In-vivo data support equivalent therapeutic efficacy of a new tobramycin inhalation solution (150mg/1.5ml) administered by the eFlow® electronic nebuliser compared to TOBI® in the PARI LC PLUS®. Journal of Cystic Fibrosis 2010;9 Suppl 1:S22. [Abstract no: 84; CENTRAL: 794286; CFGD Register: PI241a; CRS: 5500100000003569]2863284
58. Elborn JS, Flume PA, Cohen F, Loutit J, VanDevanter DR. Safety and efficacy of prolonged levofloxacin inhalation solution (APT-1026)treatment for cystic fibrosis and chronic Pseudomonas aeruginosa airway infection. Journal of Cystic Fibrosis 2016;15(5):634-40. [CFGD Register: PI262d]5462868
59. Elborn JS, Flume PA, Loutit J, Cohen F. Prolonged improvement in lung function and quality of life in cystic fibrosis: a 24-week extension study of levofloxacin nebulization solution (APT-1026) versus tobramycin nebulization solution in stable CF patients with chronic pseudomonas aeruginosa infection. Journal of Cystic Fibrosis 2014;13 Suppl 2:S16. [Abstract no: WS7.5; CENTRAL: 1000055; CFGD Register: PI262b; CRS: 5500131000000008]5462869
60. Elborn JS, Geller D, Conrad D, Aaron S, Smyth AR, Fischer R, et al. Phase 3 trial of inhaled levofloxacin (Aeruquinâ™, MP-376, APT-1026) vs. tobramycin inhalation solution (TIS) in intensively treated CF patients over 6 months. Journal of Cystic Fibrosis 2013;12 Suppl 1:S35. [Abstract no: WS17.6; CENTRAL: 867323; CFGD Register: PI262a; CRS: 5500100000011291]5462870
61. Elborn JS, Geller DE, Conrad D, Aaron SD, Smyth AR, Fischer R, et al. A phase 3, open-label, randomized trial to evaluate the safety and efficacy of levofloxacin inhalation solution (APT-1026) versus tobramycin inhalation solution in stable cystic fibrosis patients. Journal of Cystic Fibrosis: Official Journal of the European Cystic Fibrosis Society 2015;14(4):507-14. [CENTRAL: 1038490; CFGD Register: PI262c ; CRS: 5500131000000327; JID:: 101128966; PUBMED: 25592656]5462871
62. Elborn JS, Geller DE, Conrad D, Aaron SD, Smyth AR, Fischer R, et al. A phase 3, open-label, randomized trial to evaluate the safety and efficacy of levofloxacin inhalation solution (APT-1026) versus tobramycin inhalation solution in stable cystic fibrosis patients. Journal of Cystic Fibrosis: Official Journal of the European Cystic Fibrosis Society 2015;14(4):507-14. Online supplementary material. [CENTRAL: 1038490; CFGD Register: PI262e; CRS: 5500131000000327; JID:: 101128966; PUBMED: 25592656]5462872
63. Fischer R, Flume PA, Van Devanter DR, Polu K, Pecoraro M, Bhatt N, et al. Pulmonary exacerbations and changes in lung function in CF adults with P. aeruginosa treated with inhaled levofloxacin (Quinsair®) or tobramycin. Journal of Cystic Fibrosis 2016;51 Suppl 45:359. [Abstract no: 436; CENTRAL: 1262259; CFGD Register: PI283d; CRS: 5500135000001725]5462874
64. Flume P. Trial of aeroquin versus tobramycin inhalation solution (TIS) in cystic fibrosis (CF) patients. (www.clinicaltrials.gov) (accessed 21 Oct 2014) 2014. [CENTRAL: 1012530; CFGD Register: PI283a; CRS: 5500131000000187; 5500131000000187]5462877
65. Flume P, Elborn JS, Polu K, Llorens L, Pecoraro ML, Bhatt N, et al. History of pulmonary exacerbations (PEx) as a predictor of response to nebulized levofloxacin compared with nebulized tobramycin. Journal of Cystic Fibrosis: Official Journal of the European Cystic Fibrosis Society 2016;2015 Suppl 1:S61. [Abstract no: 38; CENTRAL: 1171477; CFGD Register: PI283e; CRS: 5500135000001592]5462875
66. Flume P, VanDevanter DR, Cohen F, Fleming R, Elborn JS. Safety profile of levofloxacin inhalation solution from 3 controlled cystic fibrosis trials [abstract]. Journal of Cystic Fibrosis: Official Journal of the European Cystic Fibrosis Society 2015;14 Suppl 1:S87. [Abstract no: 117; CENTRAL: 1077213; CFGD Register: PI240f // PI283c // PI284c; CRS: 5500135000001302]5462876
67. Van Devanter D, Flume PA, Fleming R, Elborn J. How often is pulmonary exacerbation defined by ≥4 Fuchs criteria associated with antibiotic treatment?. Pediatric Pulmonology 2014;49 Suppl 38:356. [Abstract no: 388; CENTRAL: 1012531; CFGD Register: PI283b // PI284b; CRS: 5500131000000188]5462878
68. Flume PA, Clancy JP, Retsch-Bogart GZ, Tullis E, Bresnik M, Derchak PA, et al. Aztreonam for inhalation solution (AZLI) and tobramycin inhalation solution (TIS) continuous alternating therapy (CAT) for cystic fibrosis (CF) patients with chronic pseudomonas aeruginosa (PA) infection: a randomized, double-blind, placebo-controlled trial. Pediatric Pulmonology 2015;50 Suppl 41:352. [Abstract no: 428; CENTRAL: 1092171; CFGD Register: PI288; CRS: 5500135000001367]5462880
69. Flume P. A Phase 3, Multi-Center, Multinational, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of MP-376 (Levofloxacin Inhalation Solution; Aeroquin™) In Stable Cystic Fibrosis Patients. www.clinicaltrials.gov (accessed 21 Oct 2014) 2014. [CENTRAL: 1012532; CFGD Register: PI284a; CRS: 5500131000000190; NCT01180634]5462883
70. Flume P, VanDevanter DR, Cohen F, Fleming R, Elborn JS. Safety profile of levofloxacin inhalation solution from 3 controlled cystic fibrosis trials. Journal of Cystic Fibrosis: Official Journal of the European Cystic Fibrosis Society 2015;14 Suppl 1:S87. [Abstract no: 117; CENTRAL: 1077213; CFGD Register: PI240f // PI283c // PI284c; CRS: 5500135000001302]5462882
71. Flume PA, VanDevanter DR, Morgan EE, Dudley MN, Loutit JS, Bell SC, et al. A phase 3, multi-center, multinational, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of levofloxacin inhalation solution (APT-1026) in stable cystic fibrosis patients. Journal of Cystic Fibrosis 2016;15(4):495-502. [CFGD Register: PI284d]5462884
72. Flume PA, VanDevanter DR, Morgan EE, Dudley MN, Loutit JS, Bell SC, et al. A phase 3, multi-center, multinational, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of levofloxacin inhalation solution (APT-1026) in stable cystic fibrosis patients. Journal of Cystic Fibrosis 2016;15(4):495-502. Online supplement. [CFGD Register: PI284e]5462885
73. Van Devanter D, Flume PA, Fleming R, Elborn J. How often is pulmonary exacerbation defined by ≥4 Fuchs criteria associated with antibiotic treatment?. Pediatric Pulmonlogy 2014;49 Suppl 38:356. [Abstract no: 388; CFGD Register: PI283b // PI284b]5462886
74. Frederiksen B, Koch C, Høiby N. Antibiotic treatment of initial colonisation with Pseudomonas aeruginosa postpones chronic infection and prevents deterioration of pulmonary function in cystic fibrosis. Pediatric Pulmonology 1997;23(5):330-5. 2863286
75. Geller DE, Howenstine M, Conrad C, Smith J, Mulye S, Shrewsbury SB. A phase 1 study to assess the tolerability of a novel tobramycin powder for inhalation (TPI) formulation in cystic fibrosis subjects. Pediatric Pulmonology 2004;38(Suppl 27):250. [CENTRAL: 507896; CFGD Register: PI187a ; CRS: 5500100000002694]2863288
76. Geller DE, Konstan MW, Smith J, Noonberg SB, Conrad C. Novel tobramycin inhalation powder in cystic fibrosis subjects: Pharmacokinetics and safety. Pediatric Pulmonology 2007;42(4):307-13. [CENTRAL: 587235; CFGD Register: PI187c ; CRS: 5500100000002919; PUBMED: 17352404]2863289
77. Rodriguez CA, Shrewsbury SB, Potter SN, Nardella P, Geller DE. Single dose pharmacokinetics of tobramycin after administration of a novel dry powder formulation (TPI) in subjects with cystic fibrosis (cf). Pediatric Pulmonology 2004;38 Suppl 27:250. [CENTRAL: 526254; CFGD Register: PI187b ; CRS: 5500100000002754]2863290
78. Conrad D, Flume P, Sindel L, Andrews S, Morgan L, Loutit J, et al. Phase 2b study of inhaled MP-376 (Aeroquin, levofloxacin inhalation solution) in stable cystic fibrosis (CF) patients with chronic Pseudomonas Aeruginosa (PA) lung infection. American Journal of Respiratory and Critical Care Medicine 2010;181(Meeting Abstracts). [CENTRAL: 1031676; CFGD Register: PI240g; CRS: 5500050000000360; EMBASE: 70839804]5462888
79. Flume P, Geller DE, Sindel L, Staab D, Fischer R, Riethmuller J, et al. Effects of inhaled MP-376 (aeroquin, levofloxacin inhalation solution) on lung function in stable cystic fibrosis (CF) patients with chronic Pseudomonas aeruginosa (PA) lung infection. Journal of Cystic Fibrosis 2010;9 Suppl 1:S23. [Abstract no: 86; CENTRAL: 774683; CFGD Register: PI240a; CRS: 5500100000003504]5462889
80. Flume P, VanDevanter DR, Cohen F, Fleming R, Elborn JS. Safety profile of levofloxacin inhalation solution from 3 controlled cystic fibrosis trials. Journal of Cystic Fibrosis: Official Journal of the European Cystic Fibrosis Society 2015;14 Suppl 1:S87. [Abstract no: 117; CENTRAL: 1077213; CFGD Register: PI240f // PI283c // PI284c; CRS: 5500135000001302]5462890
81. Flume PA, Geller DE, Loutit JS, Dudly MN, Conrad D, Mpex 204Sgroup. Effects of inhaled MP-376 (Aeroquinâ levofloxacin inhalation solution) on cystic fibrosis patients with both Staphylococcus aureus (SA) and Pseudomonas aeruginosa (PA) lung infection. Journal of Cystic Fibrosis 2011;10 Suppl 1:S22. [Abstract no: 87; CENTRAL: 849020; CFGD Register: PI240b; CRS: 5500100000010582]5462891
82. Geller DE, Flume PA, Staab D, Fischer R, Loutit JS, Conrad DJ. Levofloxacin inhalation solution (MP-376) in patients with cystic fibrosis with Pseudomonas aeruginosa. American Journal of Respiratory and Critical Care Medicine 2011;183(11):1510-6. [CENTRAL: 800852; CFGD Register: PI240d; CRS: 5500100000010625]5462892
83. Geller DE, Flume PA, Staab D, Fischer R, Loutit JS, Conrad DJ. Online supplemental methods to ;Levofloxacin inhalation solution (MP-376) in patients with cystic fibrosis with Pseudomonas aeruginosa; [online]. American Journal of Respiratory and Critical Care Medicine 2011;183(11):1510-1516 online. [CENTRAL: 1073292; CFGD Register: PI240e; CRS: 5500135000000004]5462893
84. Geller DFPA, Sindel L, Staab D, Fischer R, Loutit J, Conrad D. Effects of inhaled MP-376 (aeroquin, levofloxacin inhalation solution) on the need for other anti-pseudomonal antimicrobials in stable CF patients with chronic pseudomonas aeruginosa lung infection. Pediatric Pulmonology 2010;45 Suppl 33:301. [Abstract no: 232; CENTRAL: 848914; CFGD Register: PI240c; CRS: 5500100000010624]5462894
85. Gibson RL, Emerson J, Mayer-Hamblett N, Burns JL, McNamara S, Accurso FJ, et al. Duration of treatment effect after tobramycin solution for inhalation in young children with cystic fibrosis. Pediatric Pulmonology 2007;42(7):610-23. 2863292
86. Clancy JP, Dupont L, Konstan MW, Billings J, Fustik S, Goss CH, et al. Online supplementary data to ;Phase II studies of nebulised Arikace in CF patients with Pseudomonas aeruginosa infection; [online. Thorax 2013;68(9):818-25 online. [CFGD Register: PI222d // PI207f; CRS: 5500135000000003]5462895
87. Clancy JP, Dupont L, Konstan MW, Billings J, Fustik S, Goss CH, et al. Phase II studies of nebulised Arikace in CF patients with Pseudomonas aeruginosa infection. Thorax 2013;68(9):818-25. [CENTRAL: 876398; CFGD Register: PI222c // PI207e ; CRS: 5500050000000084; PUBMED: 23749840]5462896
88. Clancy JP, Minic P, Dupont L, Goss CH, Quittner AL, Lymp JF, et al. Full analysis of data from two phase II blinded & placebo-controlled studies of nebulized liposomal amikacin for inhalation (Arikace) in the treatment of CF patients with Pseudomonas aeruginosa lung infection. Pediatric Pulmonology 2010;45 Suppl 33:299. [Abstract no: 227; CFGD Register: PI222b //PI207d]5462897
89. Dupont LJ, Clancy JP, Minic P, Goss CH, Fustic S, Mazurek H, et al. Evaluation of two phase II blinded and placebo-controlled studies of nebulized liposomal amikacin (Arikace;) in the treatment of cystic fibrosis patients with Pseudomonas aeruginosa lung infection. American Journal of Respiratory and Critical Care Medicine 2010;181(Meeting abstracts). [Abstract no: A1836; CFGD Register: PI222e // PI207g]5462898
90. Goss CH, Clancy JP, Nick JA, Billings J, Rubenstein RC, Young KR, et al. A phase 2 blinded and placebo-controlled study of nebulized liposomal amikacin (arikace) in the treatment of CF patients with Pseudomonas aeruginosa lung infection. Pediatric Pulmonology 2009;44(S32):295. [CFGD CF Register: PI222a]2863294
91. Griese M, Mueller I, Reinhardt D. Eradication of initial Pseudomonas aeruginosa colonisation in patients with cystic fibrosis. European Journal of Medical Research 2002;7(2):79-80. 2863296
92. Heinzl B, Eber E, Oberwaldner B, Haas G, Zach M. Effects of inhaled gentamicin prophylaxis on acquisition of Pseudomonas aeruginosa in children with cystic fibrosis: a pilot study. Pediatric Pulmonology 2002;33(1):32-7. 2863298
93. Kenny S, Hall V, Goldsmith C, Moore J, Rendall JC, Elborn JS. Eradication of Pseudomonas aeruginosa in adults with CF. Journal of Cystic Fibrosis 2009;8 Suppl 2:S39. [Abstract no: 158; MEDLINE: 96296083]2863300
94. Kenny SL, Shaw TD, Downey DG, Moore JE, Rendall JC, Elborn JS. Eradication of Pseudomonas aeruginosa in adults with cystic fibrosis. BMJ Open Respiratory Research 2014;1:e000021. 2863301
95. Konstan MW, Geller DE, Brockhaus F, Zhang J, Angyalosi G. Tobramycin inhalation powder is effective and safe in the treatment of chronic pulmonary Pseudomonas aeruginosa (Pa) infection in patients with cystic fibrosis. American Journal of Respiratory and Critical Care Medicine 2009;179. [Abstract no: A1186; CENTRAL: 744126; CFGD Register: PI227a; CRS: 5500100000003455]2863303
96. Konstan MW, Geller DE, Minic P, Brockhaus F, Zhang J, Angyalosi G. Effective treatment of chronic Pseudomonas aeruginosa (Pa) infection with tobramycin inhalation powder in CF patients. Journal of Cystic Fibrosis 2009;8 Suppl 2:S27. [Abstract no: 105; CENTRAL: 744127; CFGD Register: PI227b; CRS: 5500100000003456]2863304
97. Konstan MW, Geller DE, Minic P, Brockhaus F, Zhang J, Angyalosi G. Tobramycin inhalation powder for P. aeruginosa infection in cystic fibrosis: The EVOLVE trial. Pediatric Pulmonology 2010;46:230-8. [CENTRAL: 867122; CFGD Register: PI227e; CRS: 5500100000011272; PUBMED: 20963831]2863305
98. McColley S, Rietschel E, Brockhaus F, Angyalosi G, Higgins M. Safety of inhaled tobramycin in patients with cystic fibrosis. Pediatric Pulmonology 2011;46 Suppl 34:344. [Abstract no: 365; CENTRAL: 848919; CFGD Register: PI227d // PI239h; CRS: 5500100000010634]2863306
99. Novartis (NCT00125346). Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Subjects (EVOLVE). Http://clinicaltrials.gov/ct2/show/NCT00125346 2010. [CENTRAL: 867467; CFGD Register: PI227c ; CRS: 5500100000006168]2863307
100. Chiron R, Geller DE, Angyalosi G, Debonnett L, Yadao A, Bader G, et al. Tobramycin powder for inhalation is effective in advanced stage CF lung disease: the EAGER trial. Journal of Cystic Fibrosis 2014;13 Suppl 2:S57. [Abstract no: 42; CENTRAL: 996576; CFGD Register: PI239k; CRS: 5500129000000011]5462900
101. Geller DE, Flume PA, Brockhaus F, Zhang J, Angyalosi G, He E, et al. Treatment convenience and satisfaction of tobramycin inhalation powder (TIP) versus TOBI in cystic fibrosis (CF) patients. Journal of Cystic Fibrosis 2010;9 Suppl 1:S22. [Abstract no: 82; CENTRAL: 776791; CFGD Register: PI239b; CRS: 5500100000003511]5462901
102. Geller DE, Flume PA, Konstan M, Angyalosi G, Higgins M. Microbiological and clinical response to tobramycin inhalation powder (TIPâ) in cystic fibrosis patients with chronic Pseudomonas aeruginosa (Pa) infection [abstract]. Journal of Cystic Fibrosis 2011;10 Suppl 1:S21. [Abstract no: 82; CENTRAL: 848918; CFGD Register: PI239g; CRS: 5500100000010633]5462902
103. Geller DE, Nasr SZ, Piggott S, He E, Angyalosi G, Higgins M. Tobramycin inhalation powder in cystic fibrosis patients: response by age group. Respiratory Care 2014;59(3):388-98. [CFGD Register: PI239l; CRS: 5500135000000283; PUBMED: 23983274]5462903
104. Konstan M, Flume PA, Brockhaus F, Angyalosi G, He, E, et al. Safety and efficacy of tobramycin inhalation powder (TIP) in treating CF patients infected with Pseudomonas aeruginosa (Pa). Journal of Cystic Fibrosis 2010;9 Suppl 1:S22. [Abstract no: 82; CENTRAL: 776166; CFGD Register: PI239a; CRS: 5500100000003510]5462904
105. Konstan MW, Flume PA, Brockhaus F, Angyalosi G, He E, Zhang J, et al. Tobramycin inhalation powder (TIP) versus tobramycin inhalation solution (TOBI®): the EAGER trial. Pediatric Pulmonology 2010;45 Suppl 33:303. [Abstract no: 235; CENTRAL: 848925; CFGD Register: PI239c; CRS: 5500100000010710]5462905
106. Konstan MW, Flume PA, Kappler M, Chiron R, Higgins M, Brockhaus F, et al. Safety, efficacy and convenience of tobramycin inhalation powder in cystic fibrosis patients: The EAGER trial. Journal of Cystic Fibrosis 2011;10(1):54-61. [CENTRAL: 779828; CFGD Register: PI239e; CRS: 5500100000005985]5462906
107. McColley S, Rietschel E, Brockhaus F, Angyalosi G, Higgins M. Safety of inhaled tobramycin in patients with cystic fibrosis. Pediatric Pulmonology 2011;46 Suppl 34:344. [Abstract no: 365; CENTRAL: 848919; CFGD Register: PI239h // PI227d; CRS: 5500100000010634]5462907
108. Nasr S, Nick J, Ezzet N, Gallo P, Debonnett L, Angyalosi G, et al. Reduced administration time for inhaled tobramycin in cystic fibrosis patients: results from the EAGER trial. Pediatric Pulmonology 2013;48 Suppl 36:283. [Abstract no: 219; CENTRAL: 921693; CFGD Register: PI239j; CRS: 5500125000000404]5462908
109. Regnault A, Balp M M, Kulich K, Esteve L, Viala DM. Validation of the treatment satisfaction questionnaire for medication (TSQM) in cystic fibrosis. Journal of Cystic Fibrosis 2011;10 Suppl 1:S85. [Abstract no: 332; CENTRAL: 848877; CFGD Register: PI239f; CRS: 5500100000010559]5462909
110. Regnault A, Balp MM, Kulich K, Esteve L, Viala-Danten M. Association of treatment satisfaction and compliance of cystic fibrosis (CF) patients using inhaled tobramycin treatment in the EAGER study. Journal of Cystic Fibrosis 2011;10 Suppl 1:S82. [Abstract no: 323; CENTRAL: 848926; CFGD Register: PI239d; CRS: 5500100000010711]5462910
111. Regnault A, Balp MM, Kulich K, Viala-Danten M. Validation of the treatment satisfaction questionnaire for medication in patients with cystic fibrosis. Journal of Cystic Fibrosis 2012;11(6):494-501. [CENTRAL: 867326; CFGD Register: PI239i; CRS: 5500100000011297; PUBMED: 22583743]5462911
112. Bilton D, Pressler T, Fajac I, Clancy JP, Minic P, Cipolli M, et al. Analysis of long-term liposomal amikacin for inhalation in patients with cystic fibrosis and chronic infection from pseudomonas aeruginosa. Pediatric Pulmonology 2014;49 Suppl 38:317-8. [Abstract no: 284; CENTRAL: 1012524; CFGD Register: PI280a; CRS: 5500131000000176]5462913
113. Bilton D, Pressler T, Fajac I, Clancy JP, Minic P, Cipolli M, et al. Analysis of long-term use of liposomal amikacin for inhalation (LAI) in patients with cystic fibrosis (CF) who have chronic infection from Pseudomonas aeruginosa. Journal of Cystic Fibrosis: Official Journal of the European Cystic Fibrosis Society 2015;14 Suppl 1:S85. [Abstract no: 112; CENTRAL: 1099087; CFGD Register: PI280b; CRS: 5500135000001303]5462914
114. Konstan M, Fajac I, Pressler T, Clancy JP, Sands D, Minic P, et al. Long-term study of liposomal amikacin for inhalation (LAI) in patients with cystic fibrosis (CF) and chronic pseudomonas aeruginosa infection [abstract]. Pediatric Pulmonology 2015;50 Suppl 41:270, Abstract no: 212. [CENTRAL: 1092191; CFGD Register: PI280c; CRS: 5500135000001380]5462915
115. Latzin P, Fehling M, Bauernfeind A, Reinhardt D, Kappler M, Griese M. Efficacy and safety of intravenous meropenem and tobramycin versus ceftazidime and tobramycin in cystic fibrosis. Journal of Cystic Fibrosis 2008;7(2):142-6. [CFGD Register: PI209]2863309
116. Lenoir G, Antypkin YG, Miano A, Moretti P, Zanda M, Varoli G, et al. Efficacy, safety, and local pharmacokinetics of highly concentrated nebulized tobramycin in patients with cystic fibrosis colonized with Pseudomonas aeruginosa. Paediatric Drugs 2007;9 Suppl:11-20. [CFGD Register: PI196c]2863311
117. Lenoir G, Aryayev N, Varoli G, Monici Preti P. Aerosolized tobramycin in the treatment of patients with cystic fibrosis and pseudomonas aeruginosa infection. Journal of Cystic Fibrosis 2006;5 Suppl 1:S42. [CFGD Register: PI196b]2863312
118. Lenoir G, Aryayev N, Varoli G, Monici Preti P. Highly concentrated aerosolized tobramycin in the treatment of patients with cystic fibrosis and Pseudomonas aeruginosa infection. European Respiratory Journal 2005;26 Suppl 49:620s. [CFGD Register: PI196a]2863313
119. Littlewood JM, Miller MG, Ghoneim AT, Ramsden CH. Nebulised colomycin for early pseudomonal colonisation in cystic fibrosis [letter]. Lancet 1985;1(8433):865. 2863315
120. Mainz JG, Schadlich K, Schien C, Michl R, Schelhorn-Neise P, Koitschev A, et al. Sinonasal inhalation of tobramycin vibrating aerosol in cystic fibrosis patients with upper airway Pseudomonas aeruginosa colonization: results of a randomized, double-blind, placebo-controlled pilot study. Drug Design, Development and Therapy 2014;8:209-17. [CENTRAL: 981442; CFGD Register: PI248b ; CRS: 5500125000000721; PUBMED: 24596456]2863317
121. Mainz JG, Schien C, Schadlich K, Pfister W, Schelhorn-Neise P, Koitschev A, et al. Sinonasal inhalation of tobramycin in cystic fibrosis patients with P. aeruginosa colonization of the upper airways - results of a multicentric placebo-controlled pilot study. Journal of Cystic Fibrosis 2011;10 Suppl 1:S21. [Abstract no: 83; CENTRAL: 848866; CFGD Register: PI248a ; CRS: 5500100000010543]2863318
122. Mainz JG, Schiller I, Ritschel C, Mentzel HJ, Riethmüller J, Koitschev A, et al. Sinonasal inhalation of dornase alfa in CF: A double-blind placebo-controlled cross-over pilot trial. Auris, Nasus, Larynx 2011;38(2):220-7. [CENTRAL: 781345; CFGD Register: PI248c; CRS: 5500050000000201; PUBMED: 21030168]5462916
123. Mazurek H, Chiron R, Pelikan L, Geidel C, Bolbas K, Antipkin Y, et al. Comparison of two inhaled tobramycin solutions in cystic fibrosis patients with chronic pseudomonas aeruginosa infection: results in different age subgroups. Journal of Cystic Fibrosis 2011;10 Suppl 1:S28. [Abstract no: 111; CENTRAL: 848929; CFGD Register: PI249b; CRS: 5500100000010714]2863320
124. Mazurek H, Chiron R, Varoli G, Santoro D, Cicirello H, Antipkin Y. Efficacy on lung function and safety of multiple courses of tobramycin 300mg/4 ml nebuliser solution (Bramitob) in patients with cystic fibrosis and chronic pseudomonas aeruginosa infection: results from a 48-week extension phase. Journal of Cystic Fibrosis 2012;11 Suppl1:S74. [Abstract no: 69; CENTRAL: 867264; CFGD Register: PI249c; CRS: 5500100000011290]2863321
125. Mazurek H, Lenoir G, Pelikan L, Geidel C, Bolbas K, Antipkin Y, et al. Head-to-head comparison of two inhaled tobramycin solutions in cystic fibrosis (CF) patients with chronic pseudomonas aeruginosa (Pa) infection. Journal of Cystic Fibrosis 2011;10 Suppl 1:S28. [Abstract no: 110; CENTRAL: 848928; CFGD Register: PI249a; CRS: 5500100000010713]2863322
126. Oermann CM, McCoy KS, Retsch-Bogart GZ, Gibson R, McKevitt M, Montgomery B. Antibiotic susceptibility in Pseudomonas Aeruginosa (PA) isolates following exposure to aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis. Pediatric Pulmonology 2009;44(S32):309. [Abstract no: 278; CFGD CF Register: PI220a]2863324
127. Oermann CM, McCoy KS, Retsch-Bogart GZ, Gibson R, McKevitt M, Montgomery B. Effect of repeated exposure to aztreonam for inhalation solution (AZLI) therapy on cystic fibrosis respiratory pathogens. Pediatric Pulmonology 2009;44(Suppl 32):335. [Abstract no: 353; CFGD Register: PI220d]2863325
128. Oermann CM, McCoy KS, Retsch-Bogart GZ, Gibson RL, Montgomery AB. Effect of multiple courses of Aztreonam Lysine for inhalation (AZLI) on FEV1 and weight in patients with cystic fibrosis (CF) and Pseudomonas aeruginosa (PA): analysis of 18 month data from CP-AI-006. Journal of Cystic Fibrosis 2009;8 Suppl 2:S28. [Abstract no: 107; CFGD CF Register: PI220c]2863326
129. Oermann CM, McCoy KS, Retsch-Bogart GZ, Gibson RL, Quittner AL, Montgomery AB. Adherence over multiple courses of Aztreonam for inhalation (AZLI): effect on disease- related endpoints in patients with cystic fibrosis (CF) and Pseudomonas aeruginosa (PA). Journal of Cystic Fibrosis 2009;8 Suppl 2:S28. [Abstract no: 109; CFGD CF Register: PI220b]2863327
130. Oermann CM, Retsch-Bogart GZ, Quittner AL, Gibson RL, McCoy KS, Montgomery AB, et al. An 18-month study of the safety and efficacy of repeated courses of inhaled aztreonam lysine in cystic fibrosis. Pediatric Pulmonology 2010;45(11):1121-34. [CFGD Register: PI220e]2863328
131. Quitnner AL, Henig NR, Lewis S, Derchak PA, McCoy KS, Oermann CM, et al. Effects of chronic intermittent aztreonam for inhalation solution (AZLI) on health-related quality of life (HRQOL) in persons with cystic fibrosis (CF) and P. aeruginosa. Pediatric Pulmonology 2011;46 Suppl 34:299. [Abstract no: 240; CENTRAL: 867260; CFGD Register: PI220f/PI213j; CRS: 5500100000011261]2863329
132. Postnikov SS, Semykin SYU, Kapranov NI, Perederko LV, Polikarpova SV, Khamidullina KF. Evaluation of pefloxacin efficacy and tolerability in the treatment and prophylaxis of severe infections at the children with mucoviscidosis and aplastic anaemia. Antibiotiki i Khimioterapiia 2000;45(8):25-30. [CFGD Register: PI171]2863331
133. Postnikov SS, Semykin SY, Polikarpova SV, Dubovik LG, Gracheva LA, Sagatelyan . A prospective trial on the efficacy and tolerability of twice-daily dosing (TDD) versus once-daily dosing (ODD) amikacin in cystic fibrosis patients. Journal of Cystic Fibrosis 2007;6 Suppl 1:S34. [CFGD CF Register: PI204]2863333
134. Prayle A, Jain K, Watson A, Smyth AR. Are morning doses of intravenous tobramycin less nephrotoxic than evening? Evidence from urinary biomarkers in the critic study. Pediatric Pulmonology 2013;48 Suppl 36:299. [Abstract no: 261; CENTRAL: 980338; CFGD Register: CO55 ; CRS: 5500125000000420]2863335
135. Birnbaum HG, Greenberg P, Finkelstein S, Berndt E, Otto KL, Montgomery AB, et al. Economic analysis of hospitalization and home IV anti-pseudomonal antibiotic use in CF patients on tobramycin solution for inhalation (TOBI®). Pediatric Pulmonology 1998;Suppl 17:273. [CENTRAL: 792738; CRS: 5500100000003553]2863337
136. Bowman CM. The long-term use of inhaled tobramycin in patients with cystic fibrosis. Journal of Cystic Fibrosis 2002;1 Suppl 2(Suppl 2):S194-8. [CENTRAL: 451888; CFGD Register: PI120cc; CRS: 5500100000002389]2863338
137. Burns JL, Van Dalfsen JM, Shawar RM, Otto KL, Garber RL, Quan JM, et al. Effect of chronic intermittent administration of inhaled tobramycin on respiratory microbial flora in patients with cystic fibrosis. Journal of Infectious Diseases 1999;179(5):1190-6. [CENTRAL: 161606; CRS: 5500100000000895; PUBMED: 10191222]2863339
138. Casey S, Ramsey B, Borowitz D. Nutritional benefits of chronic intermittent Pseudomonas aeruginosa suppression with tobramycin solution for inhalation in adolescents. 13th International Cystic Fibrosis Congress; 2000 June 4-8; Stockholm, Sweden. 2000:172. [CENTRAL: 302945; CRS: 5500100000001685]2863340
139. Enger C, Rothman K, Kylstra JW. Mortality rates during 2 years of treatment with intermittent inhaled tobramycin (TOBI) in CF. Pediatric Pulmonology 1999;Suppl 19:339-40. [CENTRAL: 291292; CRS: 5500100000001353]2863341
140. Fiel SB. Long term effect of tobramycin solution for inhalation on reduction of hospitalization of CF patients. European Respiratory Journal 2000;16(Suppl 31):1545. [CENTRAL: 415647; CRS: 5500100000002265]2863342
141. Fiel SB. Long term effect of tobramycin solution for inhalation on reduction of hospitalization of CF patients [abstract]. European Respiratory Journal 2000;16(Suppl 31):1545. [CENTRAL: 415647; CFGD Register: PI120dd ; CRS: 5500100000002265]2863343
142. Geller DE, Pitlick WH, Nardella PA, Tracewell WG, Ramsey BW. Pharmacokinetics and bioavailability of aerosolized tobramycin in cystic fibrosis. Chest 2002;122(1):219-26. [ CFGD Register: PI120bb ; CENTRAL: 404033; CRS: 5500100000002214]2863344
143. Graff GR, Gordon DC, Van Dalfsen JM, Burns JL. Epidemiology of Stenotrophomonas maltophilia culture in cystic fibrosis (CF) patients during the tobramycin solution for inhalation (TOBI®) study. Pediatric Pulmonology 2000;Suppl 20:283. [CENTRAL: 793580; CFGD Register: PI120p; CRS: 5500100000003564]2863345
144. Hazinski TA. Intermittent administration of inhaled tobramycin in patients with cystic fibrosis. Journal of Pediatrics 1999;135(1):130. [CENTRAL: 165714; CFGD Register: PI120j; CRS: 5500100000000909; EMBASE: 1999019576; PUBMED: 10428654]2863346
145. Konstan MW, VanDevanter DR. Peripheral white blood cell count as a surrogate marker for progression of lung disease in cystic fibrosis. Pediatric Pulmonology 2001;Suppl 22:305. [CENTRAL: 362193; CRS: 5500100000001991]2863347
146. Kylstra JW, Bowman CM, Meyer U, Montgomery AB, Schaeffler B, Stewart P, et al. Who benefits more? An age-stratified analysis of lung function and weight gain in CF patients using inhaled tobramycin. Netherlands Journal of Medicine 1999;54(Suppl):S83. [CENTRAL: 291415; CRS: 5500100000001449]2863348
147. LeLorier J, Perreault S, Birnbaum H, Greenberg P, Sheehy O. Savings in direct medical costs from the use of tobramycin solution for inhalation in patients with cystic fibrosis. Clinical Therapeutics 2000;22(1):140-51. [CENTRAL: 275378; CRS: 5500100000001232; PUBMED: 10688397]2863349
148. LiPuma JJ. Microbiological and immunologic considerations with aerosolized drug delivery. Chest 2001;120(3 Suppl):118S-23S. [CENTRAL: 356379; CRS: 5500100000001971; PUBMED: 11555566]2863350
149. MacLeod DL, Nelson LE, Shawar RM, Lin BB, Lockwood LG, Dirk JE, et al. Aminoglycoside-resistance mechanisms for cystic fibrosis Pseudomonas aeruginosa isolates are unchanged by long-term, intermittent, inhaled tobramycin treatment. Journal of Infectious Diseases 2000;181(3):1180-4. [CENTRAL: 302968; CRS: 5500100000001702]2863351
150. Moss R, Kylstra JW, Montgomery AB, Gibson R. Who benefits more? An analysis of FEV1 and weight in adolescent (age 13-<18) CF patients using inhaled tobramycin (TOBI). Pediatric Pulmonology 1999;Suppl 19:243. [CENTRAL: 291469; CRS: 5500100000001497]2863352
151. Moss RB. Administration of aerosolized antibiotics in cystic fibrosis patients. Chest 2001;120(3 Suppl):107S-13S. [CENTRAL: 368291; CRS: 5500100000002023]2863353
152. Moss RB. Long-term benefits of inhaled tobramycin in adolescent patients with cystic fibrosis. Chest 2002;121(1):55-63. [CENTRAL: 377132; CRS: 5500100000002049; PUBMED: 11796432]2863354
153. Nickerson B, Montgomery AB, Kylstra JW, Ramsey BW. Safety and effectiveness of 2 years of treatment with intermittent inhaled tobramycin in CF patients. Pediatric Pulmonology 1999;Suppl 19:243-4. [CENTRAL: 291479; CRS: 5500100000001506]2863355
154. Otto KL, Montgomery AB, Lin A, Ramsey BW. Seasonality of hospitalization for pulmonary exacerbations and lower respiratory tract infections in Phase III tobramycin solution for inhalation (TOBI®) trials. Pediatric Pulmonology 1998;Suppl 17:273. [CENTRAL: 795752; CRS: 5500100000003601]2863356
155. Quan JM, Vasiljev M, Schaeffler B, Phelps C, Burrington C, Meyer U. Treatment for exacerbation only does not arrest progressive lung function decline in CF. Netherlands Journal of Medicine 1999;54(Suppl):S84. [CENTRAL: 291523; CRS: 5500100000001545]2863357
156. Quittner A, Gordon D, Yu X. Convergence of quality of life assessments and clinical outcomes in patients enrolled in the tobramycin solution for inhalation (TSI) trials. 24th European Cystic Fibrosis Conference; 2001 June 6-9; Vienna, Austria. 2001:P326. [CENTRAL: 614345; CRS: 5500100000003153]2863358
157. Quittner AL, Buu A. Effects of tobramycin solution for inhalation on global ratings of quality of life in patients with cystic fibrosis and Pseudomonas aeruginosa infection. Pediatric Pulmonology 2002;33(4):269-76. [CENTRAL: 379174; CRS: 5500100000002059; PUBMED: 11921456]2863360
158. Quittner AL, Buu A, Gordon D. Longitudinal changes in global ratings of quality of life for patients in the tobramycin solution for inhalation (TSI) trials. Pediatric Pulmonology 2001;Suppl 22:349. [CENTRAL: 362214; CRS: 5500100000002002]2863359
159. Ramsey B, Burns J, Smith A. Safety and efficacy of Tobramycin Solution for Inhalation in patients with cystic fibrosis: The results of two phase III placebo controlled clinical trials. Pediatric Pulmonology 1997;Suppl 14:137-8. [CENTRAL: 385760; CRS: 5500100000002121]2863361
160. Ramsey BW, Bowman MC, Montgomery AB, Smith AR, TOBIStudy G. Design of phase 3 aerosolized tobramycin studies for chronic intermittent therapy. 21st European Cystic Fibrosis Conference; 1997 June 1-6; Davos, Switzerland. 1997:144. [CENTRAL: 291527; CRS: 5500100000001548]2863362
161. Ramsey BW, Bowman MC, Vasiljev-KM, Smith AR, TOBIStudy G. Results of phase 3 aerosolized tobramycin studies for chronic intermittent therapy [abstract]. 21st European Cystic Fibrosis Conference; 1997 June 1-6; Davos, Switzerland. 1997:144. [CENTRAL: 291528; CRS: 5500100000001549]2863363
162. Ramsey BW, Pepe MS, Quan JM, Otto KL, Montgomery AB, Williams Warren J, et al. Intermittent administration of inhaled tobramycin in patients with cystic fibrosis. cystic fibrosis Inhaled Tobramycin Study Group. New England Journal of Medicine 1999;340(1):23-30. [CENTRAL: 158508; CRS: 5500100000000883; PUBMED: 9878641]2863364
163. Rosenfeld M, Emerson J, Williams-Warren J, Pepe M, Smith A, Montgomery AB, et al. Defining a pulmonary exacerbation in cystic fibrosis. Journal of Pediatrics 2001;139(3):359-65. [CENTRAL: 384105; CRS: 5500100000002077; PUBMED: 11562614]2863365
164. Taylor CJ. Nebulised high dose Tobramycin (TOBI) in adolescents with cystic fibrosis. Pediatric Pulmonology 2001;Suppl 22:291. [CENTRAL: 362226; CRS: 5500100000002008]2863366
165. VanDevanter D, Hou K, Yu X. Effect of tobramycin solution for inhalation (TOBI®) on long term rates of lung function decline in Pseudomonas aeruginosa infected cystic fibrosis (CF) patients with mild to moderate lung disease. Pediatric Pulmonology 2000;Suppl 20:298. [CENTRAL: 793150; CRS: 5500100000003557]2863367
166. VanDevanter D, Yu X, Konstan MW. Effect of tobramycin solution for inhalation on circulating white blood cell counts in exacerbating and stable CF patients. 24th European Cystic Fibrosis Conference; 2001 June 6-9; Vienna, Austria. 2001:P172. [CENTRAL: 354463; CRS: 5500100000001964]2863368
167. Ratjen F, Döring G, Nikolaizik WH. Effect of inhaled tobramycin on early Pseudomonas aeruginosa colonisation in patients with cystic fibrosis. Lancet 2001;358(9286):983-4. 2863370
168. Burns JL, Stapp J, Lofland D, AIPhase 2SG. Microbiology results from a phase 2 clinical study of aztreonam lysinate for inhalation (AI): a new inhaled antibiotic to treat CF patients with Pseudomonas aeruginosa (PA). Journal of Cystic Fibrosis 2005;4 Suppl:S55. [CENTRAL: 548338; CFGD Register: PI211a ; CRS: 5500100000002786]2863372
169. Retsch-Bogart GZ, Burns JL, Otto KL, Liou TG, McCoy K, Oermann C, et al. A phase 2 study of aztreonam lysine for inhalation to treat patients with cystic fibrosis and Pseudomonas aeruginosa infection. Pediatric Pulmonology 2008;43(1):47-58. [CENTRAL: 628521; CFGD Register: PI211c; CRS: 5500100000003193; PUBMED: 18041081]2863373
170. Retsch-Bogart GZ, Gibson RL, AIPhase 2SG. A phase 2 study of aztreonam lysinate for inhalation to treat cystic fibrosis patients with Pseudomonas aeruginosa infection. American Thoracic Society International Conference; 2005 May 20-25; San Diego, USA. 2005:A576. [CENTRAL: 592963; CFGD Register: PI211b ; CRS: 5500100000002930]2863374
171. Retsch-Bogart GZ, McCoy KS, Gibson RL, Oermann CM. Sustained improvement in pulmonary function following a 28-day course of 75mg azli tid therapy. Pediatric Pulmonology 2008;43 Suppl 31:320. [CENTRAL: 675920; CFGD Register: PI211d // PI213b; CRS: 5500100000003286]2863375
172. McCoy K, Retsch-Bogart G, Gibson RL, Oermann C, Braff M, Montgomery AB. Investigation of susceptibility breakpoints for inhaled antibiotic therapies in cystic fibrosis. Pediatric Pulmonology 2010;45 Suppl 33:341. [Abstract no: 340; CENTRAL: 848913; CFGD Register: PI212g // PI213i ; CRS: 5500100000010623]2863377
173. McCoy KS, Retsch-Boagrt GZ, Gibson RL, Oermann CM, McKevitt M, Montgomery AB. Efficacy of Aztreonam Lysine for inhalation (AZLI) in patients with cystic fibrosis and drug resistant P. aeruginosa (DRPA). Journal of Cystic Fibrosis 2009;8 Suppl 2:S28. [CENTRAL: 744120; CFGD Register: PI212e // PI213e ; CRS: 5500100000003449]2863378
174. McCoy KS, Retsch-Bogart GZ, Gibson R, Oermann C, Braff MH, Montgomery AB. Relevance of established susceptibility breakpoints to clinical efficacy of inhaled antibiotic therapies in cystic fibrosis. Pediatric Pulmonology 2008;43 Suppl 31:351. [CENTRAL: 677646; CFGD Register: PI212b // PI213c; CRS: 5500100000003289]2863379
175. Plosker GL. Aztreonam lysine for inhalation solution: in cystic fibrosis. Drugs 2010;70(14):1843-55. [CENTRAL: 848912; CFGD Register: PI212f // PI213h ; CRS: 5500100000010622]2863380
176. Quittner AL, Henig NR, Lewis S, Derchak PA, McCoy KS, Oermann CM, et al. Effects of chronic intermittent aztreonam for inhalation solution (AZLI) on health-related quality of life (HRQOL) in persons with cystic fibrosis (CF) and P. aeruginosa. Pediatric Pulmonology 2011;46 Suppl 34:299. [Abstract no: 240; CENTRAL: 867260; CFGD Register: PI213j // PI220f; CRS: 5500100000011261]2863381
177. Quittner AL, Retsch-Bogart GZ, McCoy KS, Oermann CM, Gibson R, Lewis S, et al. Effect of a 28-day course of aztreonam for inhalation solution (AZLI) on responses to individual CFQ-R respiratory symptoms score questions among patients with CF. Pediatric Pulmonology 2009;44 Suppl 32:305. [Abstract no: 266; CENTRAL: 744128; CFGD Register: PI213f ; CRS: 5500100000003457]2863382
178. Retsch-Bogart GZ, McCoy KS, Gibson RL, Oermann C, Montgomery AB. Source of improvements in lung function in patients with cystic fibrosis (CF) following treatment with aztreonam lysine for inhalation (AZLI). Pediatric Pulmonology 2008;43 Suppl 31:320. [CENTRAL: 744116; CFGD Register: PI213d; CRS: 5500100000003445]2863383
179. Retsch-Bogart GZ, McCoy KS, Gibson RL, Oermann CM. Sustained improvement in pulmonary function following a 28-day course of 75mg azli tid therapy. Pediatric Pulmonology 2008;43 Suppl 31:320. [CENTRAL: 675920; CFGD Register: PI211d // PI213b; CRS: 5500100000003286]2863384
180. Retsch-Bogart GZ, Montgomery B, Gibson R, McCoy K, Oermann CM, Cooper P. Phase 3 trial (AIR-CF 1) measuring improvement in respiratory symptoms in patients with cystic fibrosis (CF) following treatment with aztreonam lysine for inhalation. Pediatric Pulmonology 2007;42 Suppl 30:310. [CENTRAL: 623759; CFGD Register: PI213a; CRS: 5500100000003182]2863385
181. Retsch-Bogart GZ, Quittner AL, Gibson RL, Oermann CM, McCoy KS, Montgomery AB, et al. Efficacy and safety of inhaled aztreonam lysine for airway pseudomonas in cystic fibrosis. Chest 2009;135(5):1223-32. [CENTRAL: 698536; CFGD Register: PI213g ; CRS: 5500100000010621]2863386
182. Rietschel E, Posselt HG, Heuer HE, Merkel N, Staab D. Pharmacokinetics of tobramycin (TOBI) after 4 and 8 weeks of continuous once daily or twice daily inhalation. Journal of Cystic Fibrosis 2009;8 Suppl 2:S27. [Abstract no: 106; CENTRAL: 795021; CFGD Register: PI232a; CRS: 5500100000003587]2863388
183. Rietschel E, Staab D, Merkel N, van Konigsbruggen S, Posselt H. Pharmacokinetics of continuous treatment with O.D. or B.I.D inhalation of tobramycin (TOBI™) via Pari Eflow™ Rapid. Pediatric Pulmonology 2010;45 Suppl 33:320. [Abstract no: 283; CENTRAL: 849031; CFGD Register: PI232c; CRS: 5500100000010629]2863389
184. TM). Journal of Cystic Fibrosis 2010;9 Suppl 1:S23. [Abstract no: 106; CENTRAL: 795018; CFGD Register: PI232b; CRS: 5500100000003586]2863390
185. Ruddy J, Emerson J, Moss R, Genatossio A, McNamara S, Burns JL, et al. Sputum tobramycin concentrations in cystic fibrosis patients with repeated administration of inhaled tobramycin. Journal of Aerosol Medicine and Pulmonary Drug Delivery 2013;26(2):69-75. [5K23RR15529/RR/NCRR: NIH HHS/United States; CENTRAL: 880221; CFGD Register: PI277; CRS: 5500127000000010; GR:: 1UL1RR025744/RR/NCRR NIH HHS/United States; JID:: 101475057; K23: RR015529/RR/NCRR NIH HHS/United States; OID: [Other ID]: NLM: PMC3621259; PMCID:: PMC3621259; PUBMED: 22620494; UL1: TR000423/TR/NCATS NIH HHS/United States]5462918
186. Schaad UB, Wedgwood J, Ruedeberg A, Kraemer R, Hampel B. Ciprofloxacin as antipseudomonal treatment in patients with cystic fibrosis. Pediatric Infectious Diseases Journal 1997;16(1):106-11. [CFGD Register: PI116]2863392
187. Schelstraete P, Deschaght P, Van Daele S, Haerynck F, Van Simaey L. Genotype based evaluation of eradication treatment of new P. aeruginosa infections in CF patients. Journal of Cystic Fibrosis 2009;8 Suppl 2:S39. [Abstract no: 156; CFGD CF Register: PI228; MEDLINE: 96296083]2863394
188. Schelstraete P, Deschaght P, Van Simaey L, Van Daele S, Haerynck F, Vaneechoutte M, et al. Genotype based evaluation of Pseudomonas aeruginosa eradication treatment success in cystic fibrosis patients. Journal of Cystic Fibrosis 2010;9(2):99-103. [CFGD Register: PI228]2863395
189. Goldman M, Schuster A, Halliburn C, Döring G, The FSG. A randomised, open label phase 3 study to evaluate the efficacy and safety of a dry powder formulation of inhaled colistimethate sodium (Colobreathe®) versus tobramycin nebuliser solution (TNS) in cystic fibrosis subjects with chronic Pseudomonas aeruginosa lung infection. Journal of Cystic Fibrosis 2012;11, Suppl 1:S12. [Abstract no: WS5.5; CENTRAL: 848917; CFGD Register: PI214b ; CRS: 5500100000010630]2863397
190. Goldman MH, Pitt T. Lack of emergence of antimicrobial resistance of Pseudomonas Aeruginosa after six months inhalation of dry powder colistimethate. Pediatric Pulmonology 2008;43 Suppl 31:331. [CFGD Register: PI214a]2863398
191. Goldman MH, Shuster A, Haliburn C, Doring G. A randomised, open label phase 3 study to evaluate the efficacy and safety of a dry powder formulation of colistimethate sodium (Colobreathe®) versus tobramycin nebuliser solution (TNS) in cystic fibrosis subjects with chronic Pseudomonas aeruginosa lung infection. Pediatric Pulmonology 2012;47(S35):353. [Abstract no: 363; CENTRAL: 849030; CFGD Register: PI214c ; CRS: 5500100000010631]2863399
192. Goldman MH, Werner T, Schuster A. Does persistence with inhaled dry powder antibiotic treatment improve tolerability?. Pediatric Pulmonology 2013;48 Suppl 36:347. [Abstract no: 389; CENTRAL: 921669; CFGD Register: PI214f; CRS: 5500125000000396]2863400
193. Schuster A, Haliburn C, Doring G, Goldman MH, FSG . Online Data Supplement to 'Safety, efficacy and convenience of colistimethate sodium dry powder for inhalation (Colobreathe DPI) in patients with cystic fibrosis: a randomised' [online] study. Thorax 2013;68(4):344-350 Online. [CENTRAL: 867327; CFGD Register: PI214e; CRS: 5500100000011299]2863401
194. Schuster A, Haliburn C, Doring G, Goldman MH, FSG . Safety, efficacy and convenience of colistimethate sodium dry powder for inhalation (Colobreathe DPI) in patients with cystic fibrosis: a randomised study. Thorax 2013;68(4):344-50. [CENTRAL: 864435; CFGD Register: PI214d; CRS: 5500100000011298; PUBMED: 23135343]2863402
195. Schuster A, Pressler T, Zhu H, Haberman R. Efficacy and safety of colistimethate sodium in a paediatric population: results from the FREEDOM trial. Journal of Cystic Fibrosis: Official Journal of the European Cystic Fibrosis Society 2015;14 Suppl 1:S87. [Abstract no: 118; CENTRAL: 1077212; CFGD Register: PI214g; CRS: 5500135000001301]5462919
196. Stass H, Delesen H, Nagelschmitz J, Staab D. Safety and pharmacokinetics of ciprofloxacin dry powder for inhalation in cystic fibrosis: a Phase I, randomized, single-dose, dose-escalation study. Journal of Aerosol Medicine and Pulmonary Drug Delivery 2015;28(2):106-15. [CENTRAL: 1037796; CFGD Register: PI215c ; CRS: 5500131000000317; JID:: 101475057; PUBMED: 25050456]5462921
197. Stass H, Ludwig M, Nagelschmitz J, Stabb D. Safety and pharmacokinetics of inhaled dry powder ciprofloxacin after single and multiple inhalations in patients with cystic fibrosis. Paediatric Pulmomology 2008;43 Suppl 31:300. [CFGD Register: PI215a]5462922
198. Stass H, Weimann B, Nagelschmitz J, Rolinck-Werninghaus C, Staab D. Tolerability and pharmacokinetic properties of ciprofloxacin dry powder for inhalation in patients with cystic fibrosis: a phase I, randomized, dose-escalation study. Clinical Therapeutics 2013;35(10):1571-81. [CFGD Register: PI215b; CRS: 5500127000000012; JID:: 7706726; PUBMED: 24054830]5462923
199. Steinkamp G, Tummler B, Malkotte R, Von der Hardt H. Treatment of Pseudomonas aeruginosa colonisation in cystic fibrosis. Archives of Disease in Childhood 1989;64(7):1022-8. 2863404
200. Steinkamp G, Schmitt-Grohe S, Doring G, Stabb D, Schubert R, Zielen S. Once weekly azithromycin in cystic fibrosis: a double-blind, randomised trial in patients with chronic Pseudomonas aeruginosa infection. Pediatric Pulmonology 2007;42(S30):300. [CFGD Register: MA19b]2863406
201. Steinkamp G, Schmitt-Grohe S, Doring G, Worlitzsch D, Staab D, Schubert R, et al. Clinical and immunomodulatory effects of once weekly azithromycin treatment in cystic fibrosis patients chronically infected with Pseudomonas aeruginosa. Journal of Cystic Fibrosis 2006;5 Suppl 1:S25. [CFGD Register: MA19a]2863407
202. Geller DE, Flume P, Schwab R, Fornos P, Conrad DJ, Morgan E, et al. A phase 1 safety, tolerability and pharmacokinetic (PK) study of MP-376 (levofloxacin solution for inhalation) in stable cystic fibrosis (CF) patients. Paediatric Pulmonology 2008;43 Suppl 31:315. [Abstract no: 321; CFGD Register: PI210b]5462925
203. Griffith DC, Hansen C, Pressler T, Balchen T, Jensen TJ, Geller DE, et al. Single-dose pharmacokinetics of aerosol MP-376 (levofloxacin solution for inhalation) in cystic fibrosis patients: PK-PD implications. Journal of Cystic Fibrosis 2008;7(Suppl 2):S26. [CFGD Register: PI210a]5462926
204. Kearns GL, Rubino CM, Griffith DC, Geller DE, Forrest A, Bhavnani SM, et al. Levofloxacin pharmacokinetics (PK) after administration of MP-376 (Levofloxacin inhalation solution; Aeroquin) in children with cystic fibrosis [abstract]. Journal of Cystic Fibrosis: Official Journal of the European Cystic Fibrosis Society 2011;10 Suppl 1:S23, Abstract no: 88. [CENTRAL: 1053535; CFGD Register: PI210d; CRS: 5500133000000015]5462927
205. Stockmann C, Hillyard B, Ampofo K, Spigarelli MG, Sherwin CM. Levofloxacin inhalation solution for the treatment of chronic Pseudomonas aeruginosa infection among patients with cystic fibrosis. Expert Review of Respiratory Medicine 2015;9(1):13-22. [CENTRAL: 1053533; CFGD Register: PI210c; CRS: 5500131000000314; JID:: 101278196; PUBMED: 25417708]5462928
206. Taccetti G, Campana S, Festini F, Mascherini M, Doring G. Early eradication therapy against Pseudomonas aeruginosa in cystic fibrosis patients. European Respiratory Journal 2005;26(3):1-4. 2863409
207. Tramper-Stranders G, Wolfs TFW, van Aalderen W, Kouwenberg J, Nagelkerke A, van der Ent CK. Prevention of initial P. aeruginosa infection in children with cystic fibrosis: a multi-centre double-blind randomised controlled trial. Journal of Cystic Fibrosis 2009;8 Suppl 2:S37. [Abstract no: 148; CFGD Register: PI231a; MEDLINE: 96296083]2863411
208. Tramper-Stranders GA, Wolfs TF, van Haren Noman S, van Aalderen WM, Nagelkerke AF, Nuijsink M, et al. Controlled trial of cycled antibiotic prophylaxis to prevent initial Pseudomonas aeruginosa infection in children with cystic fibrosis. Thorax 2010;65(10):915-20. [CENTRAL: 761942; CFGD Register: PI231b; CRS: 5500125000000359; PUBMED: 20729233]2863412
209. McColley SA, Trapnell B, Kissner D, McKevitt M, Montgomery B, Rosen J, et al. Fosfomycin/tobramycin for inhalation (FTI): microbiological results of a phase 2 placebo-controlled trial in patients with cystic fibrosis and pseudomonas aeruginosa [abstract]. Pediatric Pulmonology 2010;45 Suppl 33:338, Abstract no: 334. [CENTRAL: 848865; CFGD Register: PI247c; CRS: 5500100000010542]2863414
210. Trapnell BC, Kissner D, Montgomery AB, Newcomb T, Geller D. Fosfomycin/tobramycin for inhalation FTI): safety results of a phase 2 placebo-controlled trial in patients with cystic fibrosis and pseudomonas aeruginosa. Pediatric Pulmonology 2010;45 Suppl 33:302. [Abstract no: 234; CENTRAL: 848864; CFGD Register: PI247b; CRS: 5500100000010541]2863415
211. Trapnell BC, McColley SA, Kissner DG, Rolfe MW, Rosen JM, McKevitt M, et al. Fosfomycin/tobramycin for inhalation in patients with cystic fibrosis with pseudomonas airway infection. American Journal of Respiratory and Critical Care Medicine 2012;185(2):171-8. [CENTRAL: 814492; CFGD Register: PI247d; CRS: 5500100000010632]2863416
212. Trapnell BC, Rolfe M, McColley S, Montgomery AB, Moorehead L, Geller D. Fosfomycon/tobramycin for inhalation (FTI): efficacy results of a phase 2 placebo-controlled trial in patients with cystic fibrosis and pseudomonas aeruginosa. Pediatric Pulmonology 2010;45 Suppl 33:302. [Abstract no: 233; CENTRAL: 848927; CFGD Register: PI247a; CRS: 5500100000010712]2863417
213. Vazquez C, Municio M, Corera M, Gaztelurrutia L, Sojo A, Vitoria JC. Early treatment of Pseudomonas aeruginosa colonisation in cystic fibrosis. Acta Paediatrica Scandanavia 1993;82(3):308-9. 2863419
214. Byrnes CA, Vidmar S, Cheney JL, Carlin JB, Armstrong DS, Cooper PJ, et al. Prospective evaluation of respiratory exacerbations in children with cystic fibrosis from newborn screening to 5 years of age. Thorax 2013;68(7):643-51. [CENTRAL: 904924; CFGD Register: PE167i; CRS: 5500125000000477; PUBMED: 23345574]2863421
215. Cheney J, Vidmar S, Grimwood K, Carlin JB, Wainwright C, on behalfofACFBALSG. Interim outcomes of a Pseudomonas aeruginosa (Pa) eradication protocol in young children in the Australian Cystic Fibrosis Bronchoalveolar Lavage (ACFBAL) Study. Journal of Cystic Fibrosis 2009;8(Suppl 2):S39. [Abstract no: 157; CFGD Register: PE167c]2863422
216. Cheney J, Wainwright C, ACFBAL SG. Trials, tribulations and triumphs of a cystic fibrosis study - a behind the scenes look at the workings of an international multi-centre study. Journal of Cystic Fibrosis 2010;9 Suppl 1:S118. [Abstract no: 452; CENTRAL: 790042; CFGD Register: PE167g; CRS: 5500125000000092]2863423
217. Kidd TJ, Ramsay KA, Vidmar S, Carlin JB, Bell SC, Wainwright CE, et al. Pseudomonas aeruginosa genotypes acquired by children with cystic fibrosis by age 5-years. Journal of Cystic Fibrosis: Official Journal of the European Cystic Fibrosis Society 2015;14(3):361-9. [CENTRAL: 1131104; CRS: 5500135000001467; PE167k; PUBMED: 25563522]5462929
218. Moodie M, Lal A, Vidmar S, Armstrong DS, Byrnes CA, Carlin JB, et al. Costs of bronchoalveolar lavage-directed therapy in the first 5 years of life for children with cystic fibrosis. Journal of Pediatrics 2014;165(3):564-9. [CFGD Register: PE167j; CRS: 5500131000000365; JID:: 0375410; PUBMED: 24996984; SI:: ANZCTR/ACTRN12605000665639]5462930
219. Wainwright C, Carlin J, Cooper P, Byrnes C, Martin J, Grimwood K, et al. Australasian cystic fibrosis BAL study interim analysis. Pediatric Pulmonology 2006;41 Suppl 29:317. [CFGD Register: PE167a]2863424
220. Wainwright CE, Carlin J, Cooper P, Byrnes C, Whitehead B, Martin J, et al. Early infection with pseudomonas aeruginosa can be cleared in young children with cystic fibrosis. Pediatric Pulmonology 2002;34 Suppl 24:300-1. [CFGD Register: PI167d]2863426
221. Wainwright CE, Kidd TJ, Ramsey KA, Bell SC, Grimwood K. Australasian CF bronchoalveolar lavage (ACFBAL) study: P.Aeruginosa (PA) genotypes in pre-school CF children. Pediatric Pulmonology 2011;46 Suppl 34:320. [Abstract no: 299; CENTRAL: 874662; CFGD Register: PE167h; CRS: 5500125000000093]2863427
222. Wainwright CE, Vidmar S, Armstrong DS, Byrnes CA, Carlin JB, Cheney J, et al. Effect of bronchoalveolar lavage-directed therapy on Pseudomonas aeruginosa infection and structural lung injury in children with cystic fibrosis: a randomized trial. JAMA 2011;306(2):163-71. [CFGD Register: PI167e]2863428
223. Wainwright CE, Vidmar S, Armstrong DS, Byrnes CA, Carlin JB, Cheney J, et al. Online Supplement to 'Effect of bronchoalveolar lavage-directed therapy on Pseudomonas aeruginosa infection and structural lung injury in children with cystic fibrosis: a randomized trial' [online]. JAMA 2011;306(2):163-171 Online. [CENTRAL: 788878; CFGD Register: PE167f; CRS: 5500100000011126; PUBMED: 21750293]2863429
224. Wainwright CE, Grimwood K, Carlin JB, Vidmar S, Cooper PJ, Francis PW, et al. Safety of bronchoalveolar lavage in young children with cystic fibrosis. Pediatric Pulmonology 2008;43(10):965-72. [CFGD Register: PI167b]2863425
225. Wainwright C, Nakamura C, Geller D, Montgomery AB. A double-blind, multinational, randomized, placebo-controlled trial evaluating aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF), mild lung disease and P. aeruginosa. Journal of Cystic Fibrosis 2010;9 Suppl 1:S22. [Abstract no: 81; CFGD Register: PI243a]5462931
226. Wainwright CE, Quittner AL, Geller DE, Nakamura C, Wooldridge JL, Gibson RL, et al. Aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis, mild lung impairment, and P. aeruginosa. Journal of Cystic Fibrosis 2011;10(4):234-42. [CENTRAL: 801029; CFGD Register: PI243b; CRS: 5500100000011273; PUBMED: 21441078]2863431
227. Noah T, Ivins S, Abode K, Harris W, Henry M, Leigh M. Comparison of antibiotics for early pseudomonas infection in CF: interim data analysis. Pediatric Pulmonology 2007;42(S30):332. [CFGD Register: PI205a]2863433
228. Noah TL, Ivins SS, Abode KA, Stewart PW, Michelson PH, Harris WT, et al. Inhaled versus systemic antibiotics and airway inflammation in children with cystic fibrosis and Pseudomonas. Pediatric Pulmonology 2010;45(3):281-90. [CFGD Register: PI205b]2863434
229. Ratjen F, Alon N, Maykut R, Liu C, Angyalosi G. TOBI® for eradication of early P. aeruginosa infection in paediatric cystic fibrosis patients: the EARLY study. Journal of Cystic Fibrosis: Official Journal of the European Cystic Fibrosis Society 2016;15 Suppl 1. [Abstract no: WS01.2; CENTRAL: 1171484; CFGD Register: PI290; Clinicaltrials.gov: NCT01082367; CRS: 5500135000001599]5462933
230. Langton Hewer S. TORPEDO-CF. http://www.controlled-trials.com/ISRCTN02734162/torpedo-cf accessed 10 October 2011. [ISRCTN02734162]2863436
231. Abman SH, Ogle JW, et al. Early bacteriologic, immunologic and clinical courses of young infants with cystic fibrosis identified by neonatal screening. Journal of Pediatrics 1991;119(2):211-7.
232. Anstead M, Heltshe S, Khan U, Barbieri JT, Langkamp M, Doring G, et al. Pseudomonas aeruginosa serology and risk for re-isolation in the EPIC trial. Journal of Cystic Fibrosis 2013;12(2):147-53.
233. Armstrong D, Grimwood K, Carlin J, Carzino R, Olinsky A, Phelan P. Bronchoalveolar lavage or oropharyngeal cultures to identify lower respiratory pathogens in infants with cystic fibrosis. Pediatric Pulmonology 1996;21(5):267-75.
234. Burns JL, Gibson RL, McNamara S, Yim D, Emerson J, Rosenfeld M, et al. Longitudanal assessment of Pseudomonas aeruginosa in young children with cystic fibrosis. Journal of Infectious Diseases 2001;183(3):444-52.
235. Ciofu O, Mandsberg LF, Wang H, Hoiby N. Phenotypes selected during chronic lung infection in cystic fibrosis patients: implications for the treatment of Pseudomonas aeruginosa biofilm infections. FEMS Immunology and Medical Microbiology 2012;65(2):215-25.
236. Douglas TA, Brennan S, Gard S, Berry L, Gangell C, Stick SM, et al. Acquisition and eradication of P. aeruginosa in young children with cystic fibrosis. European Respiratory Journal 2009;33(2):305-11.
237. Döring G, Conway S, Heijerman H, Hodson M, Høiby N, Smyth A, et al. Antibiotic therapy against Pseudomonas aeruginosa: a European consensus. European Respiratory Journal 2000;16(4):749-67.
238. Döring G, Flume P, Heijerman H, Elborn JS. Treatment of lung infection in patients with cystic fibrosis: Current and future strategies. Journal of Cystic Fibrosis 2012;11(6):461-79.
239. Emerson J, Rosenfeld M, McNamara S, Ramsey B, Gibson RL. Pseudomonas aeruginosa and other predictors of mortality and morbidity in young children with cystic fibrosis. Pediatric Pulmonology 2002;34(2):91-100.
240. FitzSimmons SC. The changing epidemiology of cystic fibrosis. Journal of Pediatrics 1993;122(1):1-9.
241. Fitzsimmons S. The Cystic Fibrosis Foundation Patient Registry Report 1996. Pediatric Pulmonology 1996;Suppl 21:267-75.
242. Higgins JPT, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. BMJ 2003;327(7414):557-60.
243. Higgins JPT, Altman DG. Chapter 8: Assessing risk of bias in included studies. In: Higgins JPT, Green S (editors). Cochrane Handbook of Systematic Reviews of Interventions. Version 5.1 [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane-handbook.org.
244. Hilliard TN, Sukhani S, Francis J, Madden N, Rosenthal M, Balfour-Lynn I, et al. Bronchoscopy following diagnosis with cystic fibrosis. Archives of Disease in Childhood 2007;92(10):989-9.
245. Hudson V, Wielinski C, Regelmann W. Prognostic implications of initial oropharyngeal bacterial flora in patients with cystic fibrosis diagnosed before the age of two years. Journal of Pediatrics 1993;122(6):854-60.
246. Iacocca VF, Sibinga M, Barbero G. Respiratory Tract Bacteriology in Cystic Fibrosis. American Journal of Disease in Childhood 1963;106(3):115-24.
247. Johansen HK, Gøtzsche PC. Vaccines for preventing infection with Pseudomonas aeruginosa in cystic fibrosis. Cochrane Database of Systematic Reviews 2015, Issue 8. [DOI: 10.1002/14651858.CD001399.pub4]
248. Kerem E, Corey M, Stein R, Gold R, Levison H. Risk factors for Pseudomonas aeruginosa colonisation in cystic fibrosis patients. Pediatric Infectious Disease Journal 1990;9(7):494-8.
249. Kosorok MR, Zeng L, West SE, Rock MJ, Splaingard ML, Laxova A, et al. Acceleration of lung disease in children with cystic fibrosis after Pseudomonas aeruginosa acquisition. Pediatric Pulmonology 2001;32(4):277-87.
250. Lee TWR, Brownlee KG, Conway SP, Denton M, Littlewood JM. Evaluation of a new definition for chronic Pseudomonas aeruginosa infection in cystic fibrosis patients. Journal of Cystic Fibrosis 2003;2(1):29-34.
251. Lee TW, Brownlee KG, Denton M, Littlewood JM, Conway SP. Reduction in prevalence of chronic Pseudomonas aeruginosa infection at a regional pediatric cystic fibrosis center. Pediatric Pulmonology 2004;37(2):104-10.
252. Lee TWR. Eradication of early Pseudomonas infection in cystic fibrosis. Chronic Respiratory Disease 2009;6(2):99-107.
253. Montori VM, Devereaux PJ, Adhikari NKJ, Burns KEA, Eggert CH, Briel M, et al. Randomized Trials Stopped Early for Benefit: A Systematic Review. JAMA 2005;294(17):2203-9.
254. Muhlebach M, Stewart P, Leigh M, Noah T. Quantitation of inflammatory responses to bacteria in young cystic fibrosis and control patients. American Journal of Respiratory & Critical Care Medicine 1999;160(1):186-91.
255. Munck A, Bonacorsi S, Mariani-Kurkdjian P, Lebourgeois M, Gerardin M, Brahimi N, et al. Genotypic characterisation of Pseudomonas aeruginosa strains recovered from patients with cystic fibrosis after initial and subsequent colonisation. Pediatric Pulmonology 2001;32(4):288-92.
256. Nixon GM, Armstrong DS, Carzino R, Carlin JB, Olinsky A, Robertson CF, et al. Clinical outcome after early Pseudomonas aeruginosa infection in cystic fibrosis. Journal of Pediatrics 2001;138(5):699-704.
257. Pamukcu A, Bush A, Buchdal R. Effects of Pseudomonas aeruginosa colonisation on lung function and anthropomorphic variables in children with cystic fibrosis. Pediatric Pulmonology 1995;19(1):10-5.
258. Parad RB, Gerard CJ, Zurakowski D, Nichols DP, Pier GB. Pulmonary outcome in cystic fibrosis is influenced primarily by mucoid Pseudomonas aeruginosa infection and immune status and only modestly by genotype. Infection & Immunity 1999;67(9):4744-50.
259. Ramsey B. Drug therapy: Management of pulmonary disease in patients with cystic fibrosis. New England Journal of Medicine 1996;335(3):179-88.
260. Ratjen F, Comes G, Paul K, Posselt H, Wagner T, Harms K. Effect of continuous antistaphylococcal therapy on the rate of P.aeruginosa acquisition in patients with cystic fibrosis. Pediatric Pulmonology 2001;31(1):13-6.
261. Rosenfeld M, Emerson J, Accurso F, Armstrong D, Castille R, Grimwood K, et al. Diagnostic accuracy of oropharyngeal cultures in infants and young children with cystic fibrosis. Pediatric Pulmonology 1999;28(5):321-8.
262. Rosenfeld MR, Gibson RL, McNamara S, Emerson J, Burns JL, Castile R, et al. Early pulmonary infection, inflammation and clinical outcomes in infants with cystic fibrosis. Pediatric Pulmonology 2001;32(5):356-66.
263. Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in randomised controlled trials. JAMA 1995;273(5):408-12.
264. Smyth AR, Bell SC, Bojcin S, Bryon M, Duff A, Flume P, et al. European Cystic Fibrosis Society Standards of Care: Best Practice Guidelines. Journal of Cystic Fibrosis 2014;13(Supplement 1):S23-S42.
265. Smyth AR, Rosenfeld M. Prophylactic anti-staphylococcal antibiotics for cystic fibrosis. Cochrane Database of Systematic Reviews 2017, Issue 4. [DOI: 10.1002/14651858.CD001912.pub4]
266. Stutman HR, Lieberman JM, Nussbaum E, Marks MI. Antibiotic prophylaxis in infants and young children with cystic fibrosis: a randomised controlled trial. Journal of Pediatrics 2002;140(3):299-305.
267. Thomassen MJ, Klinger JD, Badger SJ, Van Herckren BW, Stern RC. Cultures of thoracotomy specimens confirm usefulness of sputum cultures in cystic fibrosis. Journal of Pediatrics 1984;104(3):352-6.
268. UK CF Trust. Cystic Fibrosis Trust Patient Registry User’s Guide. Bromley: UK CF Trust, 2012.
269. UK Cystic Fibrosis Trust. UK CF Registry: Annual Data Report 2015. Bromley: Cystic Fibrosis Trust, 2016.
270. UK CF Trust Control of Infection Group. Pseudomonas aeruginosa infection in people with cystic fibrosis: suggestions for prevention and control (2nd edition). UK CF Trust 2004.
271. Winnie GB, Cowan RG. Respiratory tract colonisation with Pseudomonas aeruginosa in cystic fibrosis: correlations between anti-Pseudomonas aeruginosa antibody levels and pulmonary function. Pediatric Pulmonology 1991;10(2):92-100.
272. Langton-Hewer SC, Smyth AR. Antibiotic strategies for eradicating Pseudomonas aeruginosa in people with cystic fibrosis. Cochrane Database of Systematic Reviews 2009, Issue 4. [DOI: 10.1002/14651858.CD004197.pub3]
273. Langton-Hewer SC, Smyth AR. Antibiotic strategies for eradicating Pseudomonas aeruginosa in people with cystic fibrosis. Cochrane Database of Systematic Reviews 2014, Issue 11. [DOI: 10.1002/14651858.CD004197.pub4]
274. Wood DM, Smyth A. Antibiotic strategies for eradicating Pseudomonas aeruginosa in people with cystic fibrosis. Cochrane Database of Systematic Reviews 2003, Issue 2. [DOI: 10.1002/14651858.CD004197]
275. Wood DM, Smyth AR. Antibiotic strategies for eradicating Pseudomonas aeruginosa in people with cystic fibrosis. Cochrane Database of Systematic Reviews 2006, Issue 1. [DOI: 10.1002/14651858.CD004197.pub2]