Safety Study of Aztreonam Lysine for Inhalation (AZLI) in the Treatment of Early Bronchiolitis Obliterans Syndrome (BOS)
Summary
This study is a pilot two- center study to determine if aztreonam lysine for inhalation AZLI can be safely and self-administered in lung transplant recipients with newly diagnosed bronchiolitis obliterans syndrome, grade 1 (BOS) and obtain pilot data regarding its effect on lung function in order to appropriately design and power a larger multicenter randomized study. The hypothesis is that AZLI is a safe and effective treatment for declining lung function in lung transplant recipients with early stage BOS.
Timeline
- Start
- 2013-03
- Primary completion
- 2015-03
- Completion
- 2015-04
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Aztreonam Lysine for Inhalation (AZLI); p = 0.2030; t-test, 2 sided NCT01469364 ↗
registry analysis (superiority or other test); Aztreonam Lysine for Inhalation (AZLI); p = 0.2527; t-test, 2 sided NCT01469364 ↗
registry analysis (superiority or other test); Aztreonam Lysine for Inhalation (AZLI); p = 0.34; Mean Absolute Difference -1.52; t-test, 2 sided NCT01469364 ↗
registry analysis (superiority or other test); Aztreonam Lysine for Inhalation (AZLI); p = 0.18; Median Absolute Difference 0.78; t-test, 2 sided NCT01469364 ↗
registry analysis (superiority or other test); Aztreonam Lysine for Inhalation (AZLI); p = 0.09; Median Absolute Difference 1.62; t-test, 2 sided NCT01469364 ↗
registry analysis (superiority or other test); Aztreonam Lysine for Inhalation (AZLI); p = 0.31; Median Absolute Difference -1.24; t-test, 2 sided NCT01469364 ↗
registry analysis (superiority or other test); Aztreonam Lysine for Inhalation (AZLI); p = 0.56; Median Absolute Difference 0.82; t-test, 2 sided NCT01469364 ↗
registry analysis (superiority or other test); Aztreonam Lysine for Inhalation (AZLI); p = 0.68; Median Absolute Difference 0.15; t-test, 2 sided NCT01469364 ↗
registry analysis (superiority or other test); Aztreonam Lysine for Inhalation (AZLI); p = 0.7454; t-test, 2 sided NCT01469364 ↗
registry analysis (superiority or other test); Aztreonam Lysine for Inhalation (AZLI); p = 0.9638; t-test, 2 sided NCT01469364 ↗
Publications
- Background Belperio JA, Weigt SS, Fishbein MC, Lynch JP 3rd. Chronic lung allograft rejection: mechanisms and therapy. Proc Am Thorac Soc. 2009 Jan 15;6(1):108-21. doi: 10.1513/pats.200807-073GO.
- Background Weigt SS, Wallace WD, Derhovanessian A, Saggar R, Saggar R, Lynch JP, Belperio JA. Chronic allograft rejection: epidemiology, diagnosis, pathogenesis, and treatment. Semin Respir Crit Care Med. 2010 Apr;31(2):189-207. doi: 10.1055/s-0030-1249116. Epub 2010 Mar 30.
- Background Estenne M, Maurer JR, Boehler A, Egan JJ, Frost A, Hertz M, Mallory GB, Snell GI, Yousem S. Bronchiolitis obliterans syndrome 2001: an update of the diagnostic criteria. J Heart Lung Transplant. 2002 Mar;21(3):297-310. doi: 10.1016/s1053-2498(02)00398-4. No abstract available.
- Background Lama VN, Murray S, Lonigro RJ, Toews GB, Chang A, Lau C, Flint A, Chan KM, Martinez FJ. Course of FEV(1) after onset of bronchiolitis obliterans syndrome in lung transplant recipients. Am J Respir Crit Care Med. 2007 Jun 1;175(11):1192-8. doi: 10.1164/rccm.200609-1344OC. Epub 2007 Mar 8.
- Background Christie JD, Edwards LB, Kucheryavaya AY, Aurora P, Dobbels F, Kirk R, Rahmel AO, Stehlik J, Hertz MI. The Registry of the International Society for Heart and Lung Transplantation: twenty-seventh official adult lung and heart-lung transplant report--2010. J Heart Lung Transplant. 2010 Oct;29(10):1104-18. doi: 10.1016/j.healun.2010.08.004. No abstract available.
- Background Finlen Copeland CA, Snyder LD, Zaas DW, Turbyfill WJ, Davis WA, Palmer SM. Survival after bronchiolitis obliterans syndrome among bilateral lung transplant recipients. Am J Respir Crit Care Med. 2010 Sep 15;182(6):784-9. doi: 10.1164/rccm.201002-0211OC. Epub 2010 May 27.
- Background Vos R, Vanaudenaerde BM, Ottevaere A, Verleden SE, De Vleeschauwer SI, Willems-Widyastuti A, Wauters S, Van Raemdonck DE, Nawrot TS, Dupont LJ, Verleden GM. Long-term azithromycin therapy for bronchiolitis obliterans syndrome: divide and conquer? J Heart Lung Transplant. 2010 Dec;29(12):1358-68. doi: 10.1016/j.healun.2010.05.023. Epub 2010 Jul 8.
- Background Gerhardt SG, McDyer JF, Girgis RE, Conte JV, Yang SC, Orens JB. Maintenance azithromycin therapy for bronchiolitis obliterans syndrome: results of a pilot study. Am J Respir Crit Care Med. 2003 Jul 1;168(1):121-5. doi: 10.1164/rccm.200212-1424BC. Epub 2003 Apr 2.
- Background Vos R, Vanaudenaerde BM, Geudens N, Dupont LJ, Van Raemdonck DE, Verleden GM. Pseudomonal airway colonisation: risk factor for bronchiolitis obliterans syndrome after lung transplantation? Eur Respir J. 2008 May;31(5):1037-45. doi: 10.1183/09031936.00128607. Epub 2008 Feb 6.
- Background Jain R, Hachem RR, Morrell MR, Trulock EP, Chakinala MM, Yusen RD, Huang HJ, Mohanakumar T, Patterson GA, Walter MJ. Azithromycin is associated with increased survival in lung transplant recipients with bronchiolitis obliterans syndrome. J Heart Lung Transplant. 2010 May;29(5):531-7. doi: 10.1016/j.healun.2009.12.003. Epub 2010 Feb 4.
- Background McCoy KS, Quittner AL, Oermann CM, Gibson RL, Retsch-Bogart GZ, Montgomery AB. Inhaled aztreonam lysine for chronic airway Pseudomonas aeruginosa in cystic fibrosis. Am J Respir Crit Care Med. 2008 Nov 1;178(9):921-8. doi: 10.1164/rccm.200712-1804OC. Epub 2008 Jul 24.
- Background Oermann CM, Retsch-Bogart GZ, Quittner AL, Gibson RL, McCoy KS, Montgomery AB, Cooper PJ. An 18-month study of the safety and efficacy of repeated courses of inhaled aztreonam lysine in cystic fibrosis. Pediatr Pulmonol. 2010 Nov;45(11):1121-34. doi: 10.1002/ppul.21301.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aztreonam | Small molecule | 75 mg | Inhaled |