Optimal airway antimicrobial therapy for cystic fibrosis: The role of inhaled aztreonam lysine

Expert Opinion on Pharmacotherapy

Volumn 11, Issue 8, 2010, Pages 1373-1385

  Elborn, J Stuart ^a,b   Henig, Noreen R ^c  

^a QUEEN'S UNIVERSITY BELFAST   (United Kingdom)

^b ROYAL GROUP OF HOSPITALS TRUST   (United Kingdom)

^c GILEAD SCIENCES   (United States)

Author keywords

Aztreonam lysine; Cystic fibrosis; Inhaled antibiotics; Pseudomonas aeruginosa; Pulmonary exacerbations; Respiratory

Indexed keywords

2 [[[( 2 AMINO 4 THIAZOYL)[[ 2 METHYL 4 OXO 1 SULFO 3 AZETIDINYL]CARBAMOYL]METHYLENE]AMINO]OXY] 2 METHYLPROPIONIC ACID; ANTIBIOTIC AGENT; ANTIINFECTIVE AGENT; ANTIINFLAMMATORY AGENT; AZITHROMYCIN; AZTREONAM; AZTREONAM LYSINE; BRAMITOB; CARBAPENEM DERIVATIVE; CARBENICILLIN; CAYSTON; CEFTAZIDIME; CEPHALOSPORIN DERIVATIVE; COLISTIMETHATE; COLISTIN; DORNASE ALFA; GENTAMICIN; MUCOLYTIC AGENT; PENICILLIN G; PLACEBO; PROMIXIN; PROPIONIC ACID DERIVATIVE; SODIUM CHLORIDE; SOLVENT; TOBRAMYCIN; UNCLASSIFIED DRUG;

ABDOMINAL PAIN; AEROSOL; AIRWAY; ANTIMICROBIAL THERAPY; AUSTRALIA; BRONCHOSPASM; CANADA; CLINICAL TRIAL; COUGHING; CYSTIC FIBROSIS; DISEASE EXACERBATION; DRUG EFFICACY; DRUG ERUPTION; DRUG FORMULATION; DRUG MECHANISM; DRUG METABOLISM; DRUG SAFETY; DRUG TOLERABILITY; EUROPEAN UNION; FEVER; FORCED EXPIRATORY VOLUME; HUMAN; LUNG DISEASE; MICROBIOLOGICAL EXAMINATION; MULTIPLE CYCLE TREATMENT; NEBULIZER; NOSE CONGESTION; OPEN STUDY; PHARMACODYNAMICS; POWDER INHALER; PSEUDOMONAS AERUGINOSA; PSEUDOMONAS INFECTION; RESPIRATORY TRACT INFECTION; REVIEW; RHINORRHEA; SORE THROAT; SPUTUM; SYMPTOM; THORAX PAIN; TREATMENT DURATION; TREATMENT OUTCOME; UNITED STATES; VOMITING; WHEEZING;

ADMINISTRATION, INHALATION; AEROSOLS; ANTI-BACTERIAL AGENTS; AZTREONAM; CONTROLLED CLINICAL TRIALS AS TOPIC; CYSTIC FIBROSIS; DRUG TOXICITY; HUMANS; NEBULIZERS AND VAPORIZERS; PSEUDOMONAS AERUGINOSA; PSEUDOMONAS INFECTIONS; RESPIRATORY FUNCTION TESTS; TREATMENT OUTCOME;

EID: 77952231620     PISSN: 14656566     EISSN: None     Source Type: Journal    
DOI: 10.1517/14656566.2010.482102     Document Type: Review

References (71)

1. Davis PB, Drumm M, Konstan MW. Cystic fibrosis. Am J Respir Crit Care Med 1996;154:1229-1256
2. Cystic Fibrosis Foundation Patient Registry. 2008 Annual Data Report to the Center Directors. Bethesda, Maryland: Cystic Fibrosis Foundation; 2007
3. Henry RL, Mellis CM, Petrovic L. Mucoid Pseudomonas aeruginosa is a marker of poor survival in cystic fibrosis. Pediatr Pulmonol 1992;12:158-161
4. Pamukcu A, Bush A, Buchdahl R. Effects of Pseudomonas aeruginosa colonization on lung function and anthropometric variables in children with cystic fibrosis. Pediatr Pulmonol 1995;19:10-15
5. Corey M, Edwards L, Levison H, Knowles M. Longitudinal analysis of pulmonary function decline in patients with cystic fibrosis. J Pediatr 1997;131:809-814
6. Gibson RL, Burns JL, Ramsey BW. Pathophysiology and management of pulmonary infections in cystic fibrosis. Am J Respir Crit Care Med 2003;168:918-951
7. Fogarty A, Hubbard R, Britton J. International comparison of median age at death from cystic fibrosis. Chest 2000;117:1656-1660
8. Cystic Fibrosis Trust. UK CF Registry Annual Data Report 2008. Available from: http://www.cftrust.org.uk/aboutcf/ publications/cfregistryreports/ UK-CF-Registry-Annual- Data-Report-2008.pdf [Last accessed 27 January 2010]
9. Rosenfeld M, Emerson J, Williams-Warren J, et al. Defining a pulmonary exacerbation in cystic fibrosis. J Pediatr 2001;139:359-365
10. Amadori A, Antonelli A, Balteri I, et al. Recurrent exacerbations affect FEV1 decline in adult patients with cystic fibrosis. Respir Med 2009;103:407-413
11. Hansen CR, Pressler T, Høiby N. Early aggressive eradication therapy for intermittent Pseudomonas aeruginosa airway colonization in cystic fibrosis patients: 15 years experience. J Cyst Fibros 2008;7:523-530
12. Foweraker J. Recent advances in the microbiology of respiratory tract infection in cystic fibrosis. Br Med Bull 2009;89:93-110
13. Tunney MM, Field TR, Moriarty TF, et al. Detection of anaerobic bacteria in high numbers in sputum from patients with cystic fibrosis. Am J Respir Crit Care Med 2008;177:995-1001
14. Courtney JM, Bradley J, Mccaughan J, et al. Predictors of mortality in adults with cystic fibrosis. Pediatr Pulmonol 2007;42:525-532
15. Bittar F, Richet H, Dubus JC, et al. Molecular detection of multiple emerging pathogens in sputa from cystic fibrosis patients. PLoS One 2008;3:e2908
16. Lee TW, Brownlee KG, Denton M, et al. Reduction in prevalence of chronic Pseudomonas aeruginosa infection at a regional pediatric cystic fibrosis center. Pediatr Pulmonol 2004;37:104-110
17. Taccetti G, Campana S, Neri AS, et al. Antibiotic therapy against Pseudomonas aeruginosa in cystic fibrosis. J Chemother 2008;20:166-169
18. Ho SA, Lee TW, Denton M, et al. Regimens for eradicating early Pseudomonas aeruginosa infection in children do not promote antibiotic resistance in this organism. J Cyst Fibros 2009;8:43-46
19. Douglas TA, Brennan S, Gard S, et al. Acquisition and eradication of P. aeruginosa in young children with cystic fibrosis. Eur Respir J 2009;33:305-311
20. Flume PA, O'sullivan BP, Robinson KA, et al. Cystic fibrosis pulmonary guidelines. Chronic medications for maintenance of lung health. Am J Respir Crit Care Med 2007;176:957-969
21. Heijermann H, Westerman E, Conway S, et al. Inhaled medication and inhalation devices for lung disease in patients with cystic fibrosis: a European consensus. J Cyst Fibros 2009;8:295-315
22. Smyth A, Elborn JS. Exacerbations in cystic fibrosis: 3 -- Management. Thorax 2008;63:180-184
23. Flume PA, Mogayzel PJ Jr, Robinson KA, et al. Cystic fibrosis pulmonary guidelines: treatment of pulmonary exacerbations. Am J Respir Crit Care Med 2009;180:802-808
24. Ramsey BW, Pepe MW, Quan JM, et al. Cystic fibrosis inhaled tobramycin study group. Intermittent administration of inhaled tobramycin in patients with cystic fibrosis. N Eng J Med 1999;340:23-30
25. US prescribing information, TOBI®, tobramycin inhalation solution, USP. Available from: http://www.pharma.us. novartis.com/product/pi/pdf/tobi.pdf [Last accessed 27 January 2010]
26. Hodson ME, Gallagher CG. New clinical evidence from the European tobramycin trial in cystic fibrosis. J Cyst Fibros 2002;1(Suppl 2):199-202
27. Summary of Product Characteristics (SPC), TOBI® 300°mg/5°ml Nebuliser SolutionWebsite of UK licensed medicines. Available from: http://emc. medicines.org.uk/ [Last accessed 27 January 2010]
28. Summary of Product Characteristics (SPC), Promixin® 1 MIU Powder for Nebuliser Solution. Website of UK licensed medicines. Available from: http://emc.medicines.org.uk/ [Last accessed 27 January 2010]
29. Coulthard K. Maximizing the efficacy and safety of colistimethate therapy [abstract S19.2]. Pediatr Pulmonol 2008;43(Suppl 31):193-195
30. Li J, Nation RL, Turnidge JD, et al. Colistin: the re-emerging antibiotic for multidrug-resistant Gram-negative bacterial infections. Lancet 2006;6:589-601
31. Kuhn RJ. Formulation of aerosolized therapeutics. Chest 2001;120:94S-8S
32. European Medicines Agency. Summary of Product Characteristics (SPC), Cayston® 75 mg powder and solvent for nebuliser solution. Available from: http://www.emea.europa.eu/ humandocs/PDFs/EPAR/cayston/ emea-combined-h996en.pdf [Last accessed 27 January 2010]
33. Heath Canada. Product Monograph: Cayston® (Aztreonam for Inhalation Solution 75 mg aztreonam/vial antibiotic. Available from: http://www.hc-sc.gc. ca/index-eng.php [Last accessed 27 January 2010]
34. FDA. Prescribing Information: Cayston® (aztreonam for inhalation solution). Available from: http://www.cayston.com/ media/CAYSTON-prescribe-info. pdf [Last accessed 26 February 2010]
35. Prescribing information: AZACTAM® (aztreonam) for injection, USP. Available from: http://www.elan.com/ [Last accessed 27 January 2010]
36. In: Parfitt K, editor, Aztreonam. Martindale: the complete drug reference. 32nd edition. Pharmaceutical Press, London; 1999. p. 156-157
37. Dietzsch HJ, Gottschalk B, Heyne K, et al. Cystic fibrosis: comparison of two mucolytic drugs for inhalation treatment (acetylcysteine and arginine hydrochloride). Pediatrics 1975;55:96-100
38. Georgopapadakou NH, Smith SA, Sykes RB. Mode of action of aztreonam. Antimicrob Agents Chemother 1982;21:950-956
39. Johnson DH, Cunha BA. Aztreonam. Med Clin North Am 1995;79:733-743
40. Craig WA. Basic pharmacodynamics of antibacterials with clinical applications to the use of beta-lactams, glycopeptides, and linezolid. Infect Dis Clin North Am 2003;17:479-501
41. Sykes RB, Bonner DP. Aztreonam: the first monobactam. Am J Med 1985;78:2-10
42. Brogden RN, Heel RC. Aztreonam. A review of its antibacterial activity, pharmacokinetic properties and therapeutic use. Drugs 1986;31:96-130
43. Adkinson NF Jr. Immunogenicity and cross-allergenicity of aztreonam. Am J Med 1990;88(3C):12S-5S, discussion 38S-42S
44. Geller DE. The science of aerosol delivery in cystic fibrosis. Pediatr Pulmonol 2008;43(Suppl 9):5-17
45. Gibson RL, Retsch-Bogart GZ, Oermann C, et al. Microbiology, safety and pharmacokinetics of aztreonam lysinate for inhalation in patients with cystic fibrosis. Pediatr Pulmonol 2006;41:656-665
46. Retsch-Bogart GZ, Quittner AL, Gibson RL, et al. Efficacy and safety of inhaled aztreonam lysine for airway Pseudomonas in cystic fibrosis. Chest 2009;135:1223-1232
47. McCoy KS, Quittner AL, Oermann CM, et al. Inhaled aztreonam lysine for chronic airway Pseudomonas aeruginosa in cystic fibrosis. Am J Respir Crit Care Med 2008;178:921-928
48. Hofmann T, Otto K, Kirihara J, et al. Safety and tolerability study of aztreonam for inhalation (AI) in healthy volunteers [abstract 195]. Pediatr Pulmonol 2003;36(Suppl 25):251
49. Retsch-Bogart GZ, Burns JL, Otto KL, et al. A phase 2 study of aztreonam lysine for inhalation to treat patients with cystic fibrosis and Pseudomonas aeruginosa infection. Pediatr Pulmonol 2008;43:47-58
50. Oermann CM, Retsch-Bogart GZ, McCoy KS, et al. Effect of multiple courses of aztreonam for inhalation solution (AZLI) on disease-related endpoints and safety in patients with CF: final analysis of 18-month data [abstract 241]. Pediatr Pulmonol 2009;44(Suppl 32):296
51. Oermann CS, McCoy KS, Retsch-Bogart GZ, et al. Effect of repeated exposure to aztreonam for inhalation solution (AZLI) therapy on cystic fibrosis respiratory pathogens [abstract 353]. Pediatr Pulmonol 2009;44(Suppl 32):335-336
52. Oermann CS, McCoy KS, Retsch-Bogart GZ, et al. Antibiotic susceptibility in Pseudomonas aeruginosa (PA) isolates following repeated exposure to aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis [abstract 278]. Pediatr Pulmonol 2009;44(Suppl 32):309
53. Oermann CM, Retsch-Bogart GZ, Quittner AL, et al. An 18-month study, AIR-CF3, of the safety and improvement in pulmonary function and respiratory symptoms with repeated courses of aztreonam for inhalation solution in patients with cystic fibrosis and airway Pseudomonas aeruginosa. Pediatr Pulmonol 2010; in press
54. Quittner AL, Sweeny S, Watrous M, et al. Translation and linguistic validation of a disease-specific quality of life measure for cystic fibrosis. J Pediatr Psychol 2000;25:403-414
55. Modi AC, Quittner AL. Validation of a disease-specific measure of health-related quality of life for children with cystic fibrosis. J Pediatric Psychol 2003;28:535-546
56. Quittner AL, Buu A, Messer MA, et al. Development and validation of the cystic fibrosis questionnaire in the United States: a health-related quality-of-life measure for cystic fibrosis. Chest 2005;128:2347-2354
57. Abbott J. Health-related quality of life measurement in cystic fibrosis: advances and limitations. Chron Respir Dis 2009;6:31-41
58. US FDA Guidance for Industry. Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. Available from: http://www.fda.gov/downloads/Drugs/ GuidanceCompliance RegulatoryInformation/ Guidances/UCM193282.pdf [Last accessed 27 January 2010]
59. Guyatt GH, Kirshner B, Jaeschke R. Measuring health status: what are the necessary measurement properties? J Clin Epidemiol 1992;45:1341-1345
60. Juniper EF, Guyatt GH, Willan A, Griffith LE. Determining a minimal important change in a disease-specific quality of life questionnaire. J Clin Epidemiol 1994;47:81-87
61. Testa MA. Interpretation of quality-of-life outcomes: issues that affect magnitude and meaning. Med Care 2000;38:166-174
62. Guyatt GH. Making sense of quality-of-life data. Med Care 2000;38:175-179
63. Terwee CB, Dekker FW, Wiersinga WM, et al. On assessing responsiveness of health-related quality of life instruments: guidelines for instrument evaluation. Qual Life Res 2003;12:349-362
64. Goss CH, Quittner AL. Patient-reported outcomes in cystic fibrosis. Proc Am Thorac Soc 2007;4:378-386
65. Quittner AL, Modi A, Wainwright C, et al. Determination of the minimal clinically important difference (MCID) scores for the Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Symptom scale in two populations of patients with CF and chronic Pseudomonas aeruginosa airway infection. Chest 2009;135:1610-1618
66. Montgomery AB, S Lewis M, K Higuchi M, et al. Hospitalization risk of current standard of care (SOC) vs. aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) [abstract]. Am J Respir Crit Care Med 2009;179:A1188
67. Braff M, Retsch-Bogart G, McCoy K, et al. Effect of 28-day aztreonam for inhalation solution (AZLI) therapy on cystic fibrosis (CF) respiratory pathogens [abstract]. Am J Respir Crit Care Med 2009;179:A5944
68. McCoy KS, Retsch-Bogart G, Gibson R, et al. Relevance of established susceptibility breakpoints to clinical efficacy of inhaled antibiotic therapies in cystic fibrosis [abstract 418]. Pediatr Pulmonol 2008:43(Suppl 31):351
69. Elborn JS, Hodson M, Bertram C. Implementation of European standards of care for cystic fibrosis -- control and treatment of infection. J Cyst Fibros 2009;8:211-217
70. Burns JL, Emerson J, McNamara S, et al. Antibiotic resistance in cystic fibrosis sputum isolates [abstract 373]. Pediatr Pulmonol 2008;43(Suppl 31):334
71. Jones AM, Helm JM. Emerging treatments in cystic fibrosis. Drugs 2009;69:1903-1910