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NCT00528996 · ClinicalTrials.gov registry record · Phase 2
An Efficacy and Safety Study to Compare Three Doses of BEA 2180 BR to Tiotropium and Placebo in the Respimat Inhaler.
A Phase 2 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 2,080
- Enrollment target
NCT00528996: Completed Phase 2 study, sponsored by Boehringer Ingelheim.
NCT00528996 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 2,080 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (1464% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00528996, a Phase 2 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 2,080 participants
- Enrollment target
Study Summary
The primary objective of this study is to compare the bronchodilator efficacy of three doses (50 µg, 100 µg and 200 µg) of BEA 2180 delivered by the Respimat® once daily to placebo and tiotropium bromide delivered by the Respimat® in patients with COPD. Additional objectives include comparing the effects on dyspnea and health status.
Primary Outcome
Trough Forced expiratory volume in one second (FEV1) response was defined as the change from baseline in trough FEV1. Trough FEV1 was defined as the mean of the two FEV1 measurements recorded at the pre-dose measurements (40 and 15 minutes before the drug administration) at the end of the dosing interval (24 hours post previous drug administration from the Respimat® Inhaler). Baseline FEV1 was pre-treatment FEV1 values measured at Day 1 of treatment period (baseline) prior to administration of t
Interventions
- DRUG Placebo
- DRUG Tiotropium Bromide
- DRUG BEA 2180 BR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,080 participants |
| Start Date | 2007-09-06 |
| Est. Completion | 2009-05-05 |
| Phase | Phase 2 |
What the finished NCT00528996 record still lists
NCT00528996 is an interventional study that assigns participants to a tested intervention. Its 2,080 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (1464% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00528996 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00528996 about?
NCT00528996 is a clinical study titled "An Efficacy and Safety Study to Compare Three Doses of BEA 2180 BR to Tiotropium and Placebo in the Respimat Inhaler.". The primary objective of this study is to compare the bronchodilator efficacy of three doses (50 µg, 100 µg and 200 µg) of BEA 2180 delivered by the Respimat® once daily to placebo and tiotropium bromide delivered by the Respimat® in patients with COPD. Additional objectives include comparing the ef...
What is the current status of trial NCT00528996?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 2,080 participants. The study started on 2007-09-06. Estimated completion is 2009-05-05.
What interventions are being tested in trial NCT00528996?
The interventions under investigation include: Placebo (DRUG), Tiotropium Bromide (DRUG), BEA 2180 BR (DRUG).
Who is sponsoring clinical trial NCT00528996?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00528996's enrollment target sits among peer trials
2,080 8th of 2000 higher than 1,993 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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