Phase 3
Completed N=274
Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis
Source: ClinicalTrials.gov NCT01314716 ↗Enrolled (actual)
274
Serious AEs
10.3%
Results posted
Apr 2014
Primary outcomePrimary: Change in QOL-B Respiratory Symptoms Score at Day 28 — 8.2; 3.2 units on a scale — p=0.011
Summary
The AIR-BX2 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in QOL-B Respiratory Symptoms Score at Day 28 |
8.2; 3.2 | 0.011 sig |
| SECONDARY Change in QOL-B Respiratory Symptoms Score at Day 84 |
5.6; 3.9 | 0.56 |
| SECONDARY Time to Protocol-Defined Exacerbation (PDE) |
NA; NA | — |
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 (NCT01314716). 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. Informational only — not medical advice.