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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 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 1,032 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01172821
The ClinicalTrials.gov registry entry for NCT01172821 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,032 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 2 interventions - of which placebo is the first listed.
NCT01172821 reports 0 study locations.
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.
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