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NCT00757237 · ClinicalTrials.gov registry record · Phase 3
Aztreonam for Inhalation Solution vs Tobramycin Inhalation Solution in Patients With Cystic Fibrosis & Pseudomonas Aeruginosa
A Phase 3 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 274
- Enrollment target
NCT00757237: Completed Phase 3 study, sponsored by Gilead Sciences.
NCT00757237 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
NCT00757237, 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 assess the comparative safety and effectiveness of aztreonam for inhalation solution versus tobramycin inhalation solution in adult and pediatric patients with cystic fibrosis (CF) and pulmonary Pseudomonas aeruginosa (PA) infection.
Primary Outcome
Spirometry was performed according to American Thoracic Society (ATS) guidelines at each visit. FEV1 percent predicted is a normalized value of FEV1 calculated using the Knudson equation and based upon participant age, gender, and height. Treatment effect on the relative change from baseline in FEV1 percent predicted at Day 28 (Visit 4) was tested using an analysis of covariance (ANCOVA) model-based method.
Interventions
- DRUG Aztreonam for Inhalation Solution (AZLI)
- DRUG Tobramycin Inhalation Solution (TIS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 274 participants |
| Start Date | 2008-08 |
| Est. Completion | 2010-11 |
| Phase | Phase 3 |
What the finished NCT00757237 record still lists
NCT00757237 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 Aztreonam for Inhalation Solution (AZLI) is the first listed.
NCT00757237 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00757237 about?
NCT00757237 is a clinical study titled "Aztreonam for Inhalation Solution vs Tobramycin Inhalation Solution in Patients With Cystic Fibrosis & Pseudomonas Aeruginosa". The purpose of this study was to assess the comparative safety and effectiveness of aztreonam for inhalation solution versus tobramycin inhalation solution in adult and pediatric patients with cystic fibrosis (CF) and pulmonary Pseudomonas aeruginosa (PA) infection.
What is the current status of trial NCT00757237?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 274 participants. The study started on 2008-08. Estimated completion is 2010-11.
What interventions are being tested in trial NCT00757237?
The interventions under investigation include: Aztreonam for Inhalation Solution (AZLI) (DRUG), Tobramycin Inhalation Solution (TIS) (DRUG).
Who is sponsoring clinical trial NCT00757237?
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 NCT00757237'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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