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NCT00112359 · ClinicalTrials.gov registry record · Phase 3
International Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With P. Aeruginosa
A Phase 3 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 166
- Enrollment target
NCT00112359: Completed Phase 3 study, sponsored by Gilead Sciences.
NCT00112359 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 166 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00112359, a Phase 3 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 166 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) and lung infection due to Pseudomonas aeruginosa (PA).
Primary Outcome
The CFQ-R was administered at baseline and every visit thereafter. The endpoint was change in respiratory symptoms from baseline, assessed with the CFQ-R respiratory symptoms scale (RSS; range of scores: 0-100; higher scores indicate fewer symptoms).
Interventions
- DRUG AZLI 75 mg three times a day (TID)
- DRUG Placebo three times a day (TID)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 166 participants |
| Start Date | 2005-05 |
| Est. Completion | 2007-04 |
| Phase | Phase 3 |
What the finished NCT00112359 record still lists
NCT00112359 is an interventional study that assigns participants to a tested intervention. The registered 166 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 (78% lower).
The record links to 0 conditions, and to 2 interventions - of which AZLI 75 mg three times a day (TID) is the first listed.
NCT00112359 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00112359 about?
NCT00112359 is a clinical study titled "International Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With 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) and lung infection due to Pseudomonas aeruginosa (PA).
What is the current status of trial NCT00112359?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 166 participants. The study started on 2005-05. Estimated completion is 2007-04.
What interventions are being tested in trial NCT00112359?
The interventions under investigation include: AZLI 75 mg three times a day (TID) (DRUG), Placebo three times a day (TID) (DRUG).
Who is sponsoring clinical trial NCT00112359?
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 NCT00112359's enrollment target sits among peer trials
166 1463rd of 2000 higher than 536 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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