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NCT00104520 · ClinicalTrials.gov registry record · Phase 3
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
- 211
- Enrollment target
NCT00104520: Completed Phase 3 study, sponsored by Gilead Sciences.
NCT00104520 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 211 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00104520, a Phase 3 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 211 participants
- Enrollment target
Study Summary
The purpose of this study was to evaluate the safety and efficacy of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).
Primary Outcome
The primary endpoint was time to need for a course of inhaled or IV antipseudomonal antibiotics with documented physician assessment of need for antibiotics. Antipseudomonal Antibiotic need was documented based on the presence of at least one of the following four symptoms predictive of pulmonary exacerbation: decreased exercise tolerance, increased cough, increased sputum / chest congestion, decreased appetite, or other.
Interventions
- DRUG AZLI 75 mg two times a day (BID)/three times a day (TID)
- DRUG Placebo two times a day (BID)/three times a day (TID)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 211 participants |
| Start Date | 2005-02 |
| Est. Completion | 2006-09 |
| Phase | Phase 3 |
What the finished NCT00104520 record still lists
NCT00104520 is an interventional study that assigns participants to a tested intervention. The registered 211 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 (73% lower).
The record links to 0 conditions, and to 2 interventions - of which AZLI 75 mg two times a day (BID)/three times a day (TID) is the first listed.
NCT00104520 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00104520 about?
NCT00104520 is a clinical study titled "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 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 NCT00104520?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 211 participants. The study started on 2005-02. Estimated completion is 2006-09.
What interventions are being tested in trial NCT00104520?
The interventions under investigation include: AZLI 75 mg two times a day (BID)/three times a day (TID) (DRUG), Placebo two times a day (BID)/three times a day (TID) (DRUG).
Who is sponsoring clinical trial NCT00104520?
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 NCT00104520's enrollment target sits among peer trials
211 1337th of 2000 higher than 663 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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