Aztreonam for inhalation solution, an aerosolised antibiotic for the treatment of pseudomonal airway infection in patients with cystic fibrosis

European Respiratory Disease

Volumn 7, Issue 2, 2011, Pages 117-121

  Pressler, Tacjana ^a   Henig, Noreen R ^b   Malyszczak, Witold ^c  

^a National University Hospital   (United Kingdom)

^b GILEAD SCIENCES   (United States)

^c Gilead Sciences Europe Ltd   (United Kingdom)

Author keywords

Antipseudomonal; Aztreonam for inhalation solution; Inhaled antibiotics; Pseudomonas aeruginosa; Respiratory symptoms

Indexed keywords

EID: 84870288595     PISSN: 17545552     EISSN: 17545560     Source Type: Journal    
DOI: None     Document Type: Article

References (44)

1. Davis PB, Drumm M, Konstan MW, Cystic fibrosis, Am J Respir Crit Care Med, 1996;154:1229-56.
2. Gibson RL, Burns JL, Ramsey BW, State of the art: Pathophysiology and management of pulmonary infections in cystic fibrosis, Am J Respir Crit Care Med, 2003;168:918-51.
3. 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.
4. Foweraker J, Recent advances in the microbiology of respiratory tract infection in cystic fibrosis, Br Med Bull, 2009;89:93-110.
5. Pamukcu A, Bush A, Buchdahl R, Effects of Pseudomonas aeruginosa colonization on lung function and anthropometric vaiables in children with cystic fibrosis, Pediatr Pulmonol, 1995;19:10-5.
6. Henry RL, Mellis CM, Petrovic L, Mucoid Pseudomonas aeruginosa is a marker of poor survival in cystic fibrosis, Pediatr Pulmonol, 1992;12:158-61.
7. 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.
8. 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;176:957-69.
9. Summary of Product Characteristics (SPC), TOBI® 300 mg/5mL Nebuliser Solution. Available at: website of UK licensed medicines: www.medicines.org.uk/EMC/medicine/19020/SPC/Tobi+300+mg+5+ml+Nebuliser+S olution/ (accessed 5 May 2011).
10. Summary of Product Characteristics (SPC), Promixin® 1 MIU Powder for Nebuliser Solution. Available at: website of UKlicensed medicines: www.medicines.org.uk/EMC/medicine/13495/SPC/Promixin+1+million+Internati onal+Units+(IU)+Powder+for+Nebuliser+Solution/ (accessed 5 May 2011).
11. Summary of Product Characteristics (SPC), Cayston® 75mg powder and solvent for nebuliser solution. Available at: European Medicines Agency website: www.ema.europa.eu/docs/en_GB/document_library/EPAR__Product_Information/ human/000996/WC500019992.pdf (accessed 5 May 2011).
12. Prescribing information, TOBI®, tobramycin inhalation solution, USP. Available at: www.pharma.us.novartis.com/product/pi/pdf/tobi.pdf (accessed 5 May 2011).
13. Prescribing Information: Cayston® (aztreonam for inhalation solution). Available at: www.cayston.com/prescribing_info.html (accessed 5 May 2011).
14. European Medicines Agency. EPAR summary for the public. Cayston. July 2010. Available at: www.ema.europa.eu/docs/en_GB/document_library/EPAR__Summary_for_the_publ ic/human/000996/WC500019993.pdf (accessed 5 May 2011).
15. European Medicines Agency decision. EMEA-000827-PIP01-09. 8 October 2010. Available at: www.ema.europa.eu/docs/en_GB/document_library/PIP_decision/WC500100040.p df (accessed 5 May, 2011).
16. Rosenfeld M, Emerson J, Williams-Warren J, et al. Defining a pulmonary exacerbation in cystic fibrosis, J Pediatr,2001;139:359-65
17. Smyth A, Elborn JS, Exacerbations in cystic fibrosis: 3- Management. Thorax 2008;63:180-4.
18. Flume PA, Mogayzel PJ Jr, Robinson KA, et al., Cystic fibrosis pulmonary guidelines: treatment of pulmonary exacerbations, Am J Respir Crit Care Med, 2009;180:802-8.
19. Amadori A, Antonelli A, Balteri I, et al., Recurrent exacerbations affect FEV1 decline in adult patients with cystic fibrosis, Respir Med, 2009;103:407-13.
20. Bell SC, Robinson PJ, Exacerbations in cystic fibrosis: 2- Preventions, Thorax, 2007;62:723-32.
21. Prescribing information: AZACTAM® (aztreonam) for injection, USP. Available at:http://packageinserts.bms.com/pi/pi_azactam.pdf (accessed 5 May 2011).
22. Geller DE, The science of aerosol delivery in cystic fibrosis, Pediatr Pulmonol, 2008;43:S5-17.
23. 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.
24. Elborn JS, Henig NR, Optimal airway antimicrobial therapy for cystic fibrosis: the role of inhaled aztreonam lysine, Expert Opin Pharmacother, 2010;11:1373-85.
25. Retsch-Bogart GZ, Quittner AL, Gibson RL, et al., Efficacy and safety of inhaled aztreonam lysine for airway Pseudomonas in cystic fibrosis, Chest, 2009;135:1223-32.
26. 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;178:921-8.
27. 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;41:656-65.
28. Quittner AL, Buu A, Messer MA, et al., Development and validation of the cystic fibrosis questionnaire in the Unite States: a health related quality of life measure for cystic fibrosis, Chest, 2005;128:2347-54.
29. Quittner AL, Modi AC, Wainwright C, et al., Determination of the minimal clinically important difference scores for the Cystic Fibrosis Questionnaire-Revised Respiratory Symptom Scale in two populations of patients with cystic fibrosis and chronic Pseudomonas aeruginosa airway infection, Chest, 2009;135:1610-8.
30. 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;(Suppl. 25):251.
31. 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.
32. Oermann CM, Retsch-Bogart GZ, Quittner AL, et al., An 18-month study of the safety and efficacy of repeated coursesof inhaled aztreonam lysine in cystic fibrosis, Pediatr Pulmonol, 2010;45:1121-34.
33. Wainwright, C Quittner, AL, Geller DE, et al., Aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis, mild lung impairment, and P. aeruginosa, J Cyst Fibros, 2011;10:234-42.
34. Oermann CM, Assael B, Nakamura C, et al., Aztreonam for inhalation solution (AZLI) vs. tobramycin inhalation solution (TIS), a 6-month comparative trial in cystic fibrosis patients with Pseudomonas aeruginosa [abstract 305], Pediatr Pulmonol, 2010;45(S33):327.
35. Bresnik M, Assael B, Chiron R, et al., Lung function improvement in cystic fibrosis (CF) subjects in response to treatment with aztreonam for inhalation solution (AZLI) in a single-arm extension study after multiple courses of inhaled antipseudomonal antibiotics [abstract], Am J Respir Crit Care Med, 2011;183:A1111.
36. Assael BM, Chiron R, Fischer R, et al., Lung function improvement with aztreonam 75 mg powder and solvent for nebuliser solution (AZLI) in a single-arm extension of a randomized trial of inhaled antipseudomonal antibiotics in patients with cystic fibrosis (CF) and Pseudomonas aeruginosa infection [abstract 86], J Cyst Fibros, 2011;10(S1):S22.
37. Clinical Trials Registry ID NCT01059565. Available at: http://clinicaltrials.gov/ct2/show/NCT01059565 (accessed 5 May 2011)
38. Moskowitz SM, Silva SJ, Mayer-Hamblett N, et al., Investigators and Coordinators of the Epidemiologic Study of Cystic Fibrosis (ESCF). Shifting patterns of inhaled antibiotic use in cystic fibrosis, Pediatr Pulmonol, 2008;43:874-81.Clinical Trials Registry ID NCT01059565. Available at: http://clinicaltrials.gov/ct2/show/NCT01059565 (accessed 5 May 2011).
39. McColley SA, Trapnell B, Kissner D, et al., Fosfomycin/tobramycin for inhalation (FTI): Microbiological results of aphase 2 placebo-controlled trial in patients with cystic fibrosis and Pseudomonas aeruginosa [Abstract 334], Pediatr Pulmonol, 2010:45(Suppl. 33):338.
40. Trapnell BC, Kissner D, Montgomery AB, et al., Fosfomycin/tobramycin for inhalation (FTI): Safety results of a phase 2 placebo-controlled trial in patients with cystic fibrosis and Pseudomonas aeruginosa [Abstract 234], Pediatr Pulmonol, 2010:45(Suppl. 33):302.
41. Trapnell BC, Rolfe M, McColley S, et al., Fosfomycin/tobramycin for inhalation (FTI): Efficacy results of a phase 2 placebo-controlled trial in patients with cystic fibrosis and Pseudomonas aeruginosa [Abstract 233], Pediatr Pulmonol, 2010:45(Suppl. 33):302.
42. Clinical Trials Registry ID NCT01319253. Available at: http://clinicaltrials.gov/ct2/show/nct01319253 (accessed 5 May 2011).
43. Clinical Trials Registry ID NCT01313624. Available at: http://clinicaltrials.gov/ct2/show/NCT01313624 (accessed 5 May 2011).
44. Clinical Trials Registry ID NCT01314716. Available at: http://clinicaltrials.gov/ct2/show/NCT01314716 (accessed 5 May 2011).