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NCT01126437 · ClinicalTrials.gov registry record · Phase 3
Comparison of Tiotropium in the HandiHaler Versus the Respimat in Chronic Obstructive Pulmonary Disease
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 17,183
- Enrollment target
NCT01126437: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT01126437 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 17,183 participants, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (2129% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01126437, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 17,183 participants
- Enrollment target
Study Summary
Direct comparison studies of the tiotropium HandiHaler® 18 µg and Respimat® 5 µg formulations have been limited to 4-week crossover studies. Therefore, prospective data from a trial of adequate size and duration is required to establish that compared to tiotropium HandiHaler®, tiotropium Respimat® will have (a) similar effects on safety and (b) similar or superior effects on exacerbations.
Primary Outcome
Number of patients with all-cause mortality
Interventions
- DRUG tiotropium 18 mcg
- DRUG tiotropium 1.25 mcg (2 actuations/day)
- DRUG tiotropium 2.5 mcg (2 actuations/day)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17,183 participants |
| Start Date | 2010-05 |
| Est. Completion | 2013-05 |
| Phase | Phase 3 |
What the finished NCT01126437 record still lists
NCT01126437 is an interventional study that assigns participants to a tested intervention. Its 17,183 participants enrollment target places it among the larger protocols in the corpus, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (2129% higher).
The record links to 0 conditions, and to 3 interventions - of which tiotropium 18 mcg is the first listed.
NCT01126437 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01126437 about?
NCT01126437 is a clinical study titled "Comparison of Tiotropium in the HandiHaler Versus the Respimat in Chronic Obstructive Pulmonary Disease". Direct comparison studies of the tiotropium HandiHaler® 18 µg and Respimat® 5 µg formulations have been limited to 4-week crossover studies. Therefore, prospective data from a trial of adequate size and duration is required to establish that compared to tiotropium HandiHaler®, tiotropium Respimat® w...
What is the current status of trial NCT01126437?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 17,183 participants. The study started on 2010-05. Estimated completion is 2013-05.
What interventions are being tested in trial NCT01126437?
The interventions under investigation include: tiotropium 18 mcg (DRUG), tiotropium 1.25 mcg (2 actuations/day) (DRUG), tiotropium 2.5 mcg (2 actuations/day) (DRUG).
Who is sponsoring clinical trial NCT01126437?
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 NCT01126437's enrollment target sits among peer trials
17,183 12th of 2000 higher than 1,989 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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