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NCT01313624 · ClinicalTrials.gov registry record · Phase 3
Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis
A Phase 3 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 266
- Enrollment target
NCT01313624: Completed Phase 3 study, sponsored by Gilead Sciences.
NCT01313624 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 266 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01313624, a Phase 3 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 266 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG AZLI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 266 participants |
| Start Date | 2011-04 |
| Est. Completion | 2013-06 |
| Phase | Phase 3 |
What the finished NCT01313624 record still lists
NCT01313624 is an interventional study that assigns participants to a tested intervention. The registered 266 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (66% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01313624 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01313624 about?
NCT01313624 is a clinical study titled "Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis". 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. Fol...
What is the current status of trial NCT01313624?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 266 participants. The study started on 2011-04. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01313624?
The interventions under investigation include: Placebo (DRUG), AZLI (DRUG).
Who is sponsoring clinical trial NCT01313624?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01313624's enrollment target sits among peer trials
266 1222nd of 2000 higher than 778 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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