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NCT00645788 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate the Safety and Efficacy of Ciprofloxacin (Inhaled) in Patients With Cystic Fibrosis
A Phase 2 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 2
- Development phase
- 288
- Enrollment target
NCT00645788: Completed Phase 2 study, sponsored by Bayer.
NCT00645788 is a Phase 2 study that has completed, run by Bayer. The registered enrollment target is 288 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (117% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00645788, a Phase 2 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 288 participants
- Enrollment target
Study Summary
To evaluate the change in forced expiratory volume (FEV1) from baseline to Day 28-30 between Cipro Inhale-treated and placebo-treated subjects after a 4-week treatment period.
Primary Outcome
FEV1: The maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration, expressed in liters at body temperature and ambient pressure saturated with water vapor (BTPS). This was recorded at the site using a spirometer. The later time point minus baseline, days as planned and the last observation carried forward (LOCF) used.
Interventions
- DRUG Placebo
- DRUG Ciprofloxacin (Cipro Inhale, BAYQ3939)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 288 participants |
| Start Date | 2008-05 |
| Est. Completion | 2011-01 |
| Phase | Phase 2 |
What the finished NCT00645788 record still lists
NCT00645788 is an interventional study that assigns participants to a tested intervention. The registered 288 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (117% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00645788 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00645788 about?
NCT00645788 is a clinical study titled "Study to Evaluate the Safety and Efficacy of Ciprofloxacin (Inhaled) in Patients With Cystic Fibrosis". To evaluate the change in forced expiratory volume (FEV1) from baseline to Day 28-30 between Cipro Inhale-treated and placebo-treated subjects after a 4-week treatment period.
What is the current status of trial NCT00645788?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 288 participants. The study started on 2008-05. Estimated completion is 2011-01.
What interventions are being tested in trial NCT00645788?
The interventions under investigation include: Placebo (DRUG), Ciprofloxacin (Cipro Inhale, BAYQ3939) (DRUG).
Who is sponsoring clinical trial NCT00645788?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00645788's enrollment target sits among peer trials
288 191st of 2000 higher than 1,810 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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