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NCT01172821 · ClinicalTrials.gov registry record · Phase 3
Evaluation of Tiotropium 2.5 and 5 mcg Once Daily Delivered Via the Respimat® Inhaler Compared to Placebo and Salmeterol HydroFluoroAlkane (HFA) Metered Dose Inhaler (MDI) (50 mcg Twice Daily) in Patient With Moderate Persistent Asthma II
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,032
- Enrollment target
NCT01172821: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT01172821 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 1,032 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01172821, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,032 participants
- Enrollment target
Study Summary
The aim of this trial is to evaluate the efficacy and safety of 2.5 and 5 mcg tiotropium over a 24-week treatment period as compared to placebo and salmeterol (50 mcg twice daily). Tiotropium inhalation solution delivered by the Respimat® inhaler will be examined on top of maintenance treatment with inhaled corticosteroid controller medication in patients with moderate persistent asthma. Efficacy and safety will be assessed by measuring effects on lung function, effects on asthma exacerbations, effects on quality of life, effects on asthma control, effects on health care resource utilisation, and number of adverse events.
Primary Outcome
Peak forced expiratory volume in one second (FEV1) response within 3 hours post-dose determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.
Interventions
- DRUG placebo
- DRUG tiotropium Respimat® low dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,032 participants |
| Start Date | 2010-08 |
| Est. Completion | 2012-11 |
| Phase | Phase 3 |
What the finished NCT01172821 record still lists
NCT01172821 is an interventional study that assigns participants to a tested intervention. Its 1,032 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% higher).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01172821 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01172821 about?
NCT01172821 is a clinical study titled "Evaluation of Tiotropium 2.5 and 5 mcg Once Daily Delivered Via the Respimat® Inhaler Compared to Placebo and Salmeterol HydroFluoroAlkane (HFA) Metered Dose Inhaler (MDI) (50 mcg Twice Daily) in Patient With Moderate Persistent Asthma II". The aim of this trial is to evaluate the efficacy and safety of 2.5 and 5 mcg tiotropium over a 24-week treatment period as compared to placebo and salmeterol (50 mcg twice daily). Tiotropium inhalation solution delivered by the Respimat® inhaler will be examined on top of maintenance treatment with...
What is the current status of trial NCT01172821?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,032 participants. The study started on 2010-08. Estimated completion is 2012-11.
What interventions are being tested in trial NCT01172821?
The interventions under investigation include: placebo (DRUG), tiotropium Respimat® low dose (DRUG).
Who is sponsoring clinical trial NCT01172821?
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 NCT01172821's enrollment target sits among peer trials
1,032 288th of 2000 higher than 1,713 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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