CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 266 enrolled
Drug / intervention
AZLI +1 moredrug
Likely dose
AZLI 75 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01313624
NCT01313624Phase 3Completed
CompareCT.gov

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

Gilead Sciences·interventional·Posted Mar 14, 2011·Updated Apr 16, 2014

In Brief

A Phase 3 clinical trial evaluating AZLI and Placebo for Bronchiectasis. Completed, enrolled 266 participants across 60 sites in 3 countries.

Detailed 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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBronchiectasis
CountriesAustralia, Canada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 14, 2011
Enrollment StartApr 1, 2011
Primary CompletionMar 1, 2013
Study CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 15.3 years ago

Interventions

AZLIdrug

AZLI 75 mg reconstituted with diluent and administered via nebulizer three times daily

Placebodrug

Placebo to match AZLI administered via nebulizer three times daily