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NCT00782509 · ClinicalTrials.gov registry record · Phase 3
12 / 48 wk Pivotal PFT vs PBO in COPD II
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 644
- Enrollment target
NCT00782509: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT00782509 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 644 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00782509, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 644 participants
- Enrollment target
Study Summary
This primary objective of this study is to compare two doses of BI 1744 CL inhalation solution delivered by the Respimat® inhaler once daily to placebo in patients with chronic obstructive pulmonary disease (COPD).
Primary Outcome
Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours po
Interventions
- DRUG Placebo
- DRUG Olodaterol (BI 1744)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 644 participants |
| Start Date | 2009-02 |
| Phase | Phase 3 |
What the finished NCT00782509 record still lists
NCT00782509 is an interventional study that assigns participants to a tested intervention. The registered 644 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 (17% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00782509 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00782509 about?
NCT00782509 is a clinical study titled "12 / 48 wk Pivotal PFT vs PBO in COPD II". This primary objective of this study is to compare two doses of BI 1744 CL inhalation solution delivered by the Respimat® inhaler once daily to placebo in patients with chronic obstructive pulmonary disease (COPD).
What is the current status of trial NCT00782509?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 644 participants. The study started on 2009-02.
What interventions are being tested in trial NCT00782509?
The interventions under investigation include: Placebo (DRUG), Olodaterol (BI 1744) (DRUG).
Who is sponsoring clinical trial NCT00782509?
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 NCT00782509's enrollment target sits among peer trials
644 572nd of 2000 higher than 1,428 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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