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NCT00128492 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis (CF) Patients With Pseudomonas Aeruginosa (PA)
A Phase 3 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 274
- Enrollment target
NCT00128492: Completed Phase 3 study, sponsored by Gilead Sciences.
NCT00128492 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
NCT00128492, a Phase 3 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 274 participants
- Enrollment target
Study Summary
The purpose of this study was to evaluate the safety and efficacy of multiple courses of AZLI in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).
Primary Outcome
Participants experiencing at least 1 treatment-emergent AE or at least 1 serious adverse event (SAE) were summarized for the study as a whole. A treatment-emergent AE was any physical or clinical worsening in symptoms or disease experienced by the participant, whether or not the event was considered related to study participation or study procedures. An SAE was any adverse experience that resulted in hospitalization or death. Participants were monitored for AEs and SAEs during all on-treatment
Interventions
- DRUG AZLI 75 mg two times a day (BID)/ three times a day (TID)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 274 participants |
| Start Date | 2005-08 |
| Est. Completion | 2009-01 |
| Phase | Phase 3 |
What the finished NCT00128492 record still lists
NCT00128492 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 1 intervention - of which AZLI 75 mg two times a day (BID)/ three times a day (TID) is the first listed.
NCT00128492 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00128492 about?
NCT00128492 is a clinical study titled "Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis (CF) Patients With Pseudomonas Aeruginosa (PA)". The purpose of this study was to evaluate the safety and efficacy of multiple courses of AZLI in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).
What is the current status of trial NCT00128492?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 274 participants. The study started on 2005-08. Estimated completion is 2009-01.
What interventions are being tested in trial NCT00128492?
The interventions under investigation include: AZLI 75 mg two times a day (BID)/ three times a day (TID) (DRUG).
Who is sponsoring clinical trial NCT00128492?
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 NCT00128492'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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