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NCT01314716 · 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
- 274
- Enrollment target
NCT01314716: Completed Phase 3 study, sponsored by Gilead Sciences.
NCT01314716 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 274 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01314716, a Phase 3 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 274 participants
- Enrollment target
Study 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.
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 | 274 participants |
| Start Date | 2011-04 |
| Est. Completion | 2013-07 |
| Phase | Phase 3 |
What the finished NCT01314716 record still lists
NCT01314716 is an interventional study that assigns participants to a tested intervention. The registered 274 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 (65% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01314716 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01314716 about?
NCT01314716 is a clinical study titled "Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis". 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. Fol...
What is the current status of trial NCT01314716?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 274 participants. The study started on 2011-04. Estimated completion is 2013-07.
What interventions are being tested in trial NCT01314716?
The interventions under investigation include: Placebo (DRUG), AZLI (DRUG).
Who is sponsoring clinical trial NCT01314716?
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 NCT01314716's enrollment target sits among peer trials
274 1207th of 2000 higher than 788 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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