A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Repeated Courses of Aztreonam for Inhalation Solution in Subjects With Non-CF Bronchiectasis and Gram-Negative Endobronchial Infection
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Gilead Sciences
- Enrollment
- 266
- Locations
- 60
- Primary Endpoint
- Change in QOL-B Respiratory Symptoms Score at Day 28
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
AZLI-AZLI
Participants were randomized to receive blinded AZLI for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI for 28 days plus 56 days of treatment-free follow-up.
Intervention: AZLI (Drug)
Placebo-AZLI
Participants were randomized to receive blinded placebo to match AZLI for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI for 28 days plus 56 days of treatment-free follow-up.
Intervention: AZLI (Drug)
Placebo-AZLI
Participants were randomized to receive blinded placebo to match AZLI for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI for 28 days plus 56 days of treatment-free follow-up.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change in QOL-B Respiratory Symptoms Score at Day 28
Time Frame: Baseline to Day 28
The mean (SD) change in the Respiratory Symptoms score on the Quality of Life Questionnaire-Bronchiectasis (QOL-B) was measured from baseline to the end of Course 1 (Day 28). The QOL-B respiratory symptoms score was transformed onto a scale of 0-100, with higher scores representing a better quality of life.
Secondary Outcomes
- Change in QOL-B Respiratory Symptoms Score at Day 84(Baseline to Day 84)
- Time to Protocol-Defined Exacerbation (PDE)(Baseline to Day 112)