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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 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 17,183 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01126437
The ClinicalTrials.gov registry entry for NCT01126437 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 17,183 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which tiotropium 18 mcg is the first listed.
NCT01126437 reports 0 study locations.
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.
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