Phase 3
N=266
Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis
Bronchiectasis
Bottom Line
View on ClinicalTrials.gov: NCT01313624 ↗Enrolled (actual)
266
Serious AEs
14.1%
Results posted
Apr 2014
Primary outcome: Primary: Change in QOL-B Respiratory Symptoms Score at Day 28 — 7.4; 5.7 units on a scale — p=0.68
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- AZLI (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Gilead Sciences
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in QOL-B Respiratory Symptoms Score at Day 28 |
7.4; 5.7 | 0.68 |
| SECONDARY Change in QOL-B Respiratory Symptoms Score at Day 84 |
7.4; 4.7 | 0.56 |
| SECONDARY Time to Protocol-Defined Exacerbation (PDE) |
NA; 120 | — |
Summary
The AIR-BX1 study enrolled people with non-cystic fibrosis (non-CF) bronchiectasis and gram-negative airway infection. Participants received two 28-day courses of either Aztreonam for Inhalation Solution (AZLI) or placebo taken 3 times a day. Each course was followed by a 28-day off-drug period. Following the two blinded courses, all participants received a 28-day course of open-label AZLI then were followed for an additional 56 days.
Eligibility Criteria
Inclusion Criteria
- Male/Female 18 years or older with non-CF bronchiectasis
- Chronic sputum production on most days
- Positive sputum culture for gram-negative organisms
- Must have met lung function requirements
Exclusion Criteria
- History of CF
- Hospitalized within 14 days prior to joining the study
- Previous exposure to AZLI
- Pregnant, breastfeeding, or unwilling to follow contraceptive measures for the study
- Must have met liver and kidney function requirements
- Continuous oxygen use of greater than 2 liters per minute (supplemental oxygen with activity and at night was allowed)
- Treatment for nontuberculous mycobacteria infection or active mycobacterium tuberculosis infection within 1 year of enrollment
- Other serious medical conditions.
Data sourced from ClinicalTrials.gov (NCT01313624). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.