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NCT00712166 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Patients With Cystic Fibrosis, Mild Lung Disease, and P. Aeruginosa
A Phase 3 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 160
- Enrollment target
NCT00712166: Completed Phase 3 study, sponsored by Gilead Sciences.
NCT00712166 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 160 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00712166, a Phase 3 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 160 participants
- Enrollment target
Study Summary
The purpose of this study was to evaluate the safety and efficacy of a 28-day course of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF), mild lung disease (forced expiratory volume in 1 second \[FEV1\] \>75% predicted, and Pseudomonas aeruginosa (PA) infection.
Primary Outcome
The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for children and adults with CF. The CFQ-R contains both general and CF-specific scales. The CFQ-R was administered at Days 0, 14, 28, and 42. The endpoint was change in respiratory symptoms (e.g., coughing, congestion, wheezing) from Day 0 (baseline), assessed with the CFQ-R RSS (score range: 0-100; higher scores indicating fewer symptoms, higher health-related quality of life, or better functioning). Bas
Interventions
- DRUG AZLI 75 mg three times daily (TID)
- DRUG Placebo three times daily (TID)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2008-05 |
| Est. Completion | 2009-08 |
| Phase | Phase 3 |
What the finished NCT00712166 record still lists
NCT00712166 is an interventional study that assigns participants to a tested intervention. The registered 160 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 (79% lower).
The record links to 0 conditions, and to 2 interventions - of which AZLI 75 mg three times daily (TID) is the first listed.
NCT00712166 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00712166 about?
NCT00712166 is a clinical study titled "Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Patients With Cystic Fibrosis, Mild Lung Disease, and P. Aeruginosa". The purpose of this study was to evaluate the safety and efficacy of a 28-day course of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF), mild lung disease (forced expiratory volume in 1 second \[FEV1\] \>75% predicted, and Pseudomonas aeruginosa (PA) infection.
What is the current status of trial NCT00712166?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 160 participants. The study started on 2008-05. Estimated completion is 2009-08.
What interventions are being tested in trial NCT00712166?
The interventions under investigation include: AZLI 75 mg three times daily (TID) (DRUG), Placebo three times daily (TID) (DRUG).
Who is sponsoring clinical trial NCT00712166?
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 NCT00712166's enrollment target sits among peer trials
160 1479th of 2000 higher than 500 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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