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NCT01634152 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of 2 Doses of Tiotropium Respimat® Compared to Placebo in Children With Severe Persistent Asthma
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 401
- Enrollment target
NCT01634152 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 401 participants.
The verdict
NCT01634152, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 401 participants
- Enrollment target
Study Summary
The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation solution (2.5 mcg and 5 mcg) delivered via Respimat® inhaler once daily in the evening over 12 weeks, compared to placebo, as add-on controller therapy on top of usual care in children (6 to 11 years old) with severe persistent asthma.
Interventions
- DRUG Placebo
- DRUG Tiotropium low dose mcg
- DRUG Tiotropium high dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 401 participants |
| Start Date | 2012-07 |
| Est. Completion | 2015-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01634152
The ClinicalTrials.gov registry entry for NCT01634152 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 401 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 Placebo is the first listed.
NCT01634152 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01634152 about?
NCT01634152 is a clinical study titled "Efficacy and Safety of 2 Doses of Tiotropium Respimat® Compared to Placebo in Children With Severe Persistent Asthma". The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation solution (2.5 mcg and 5 mcg) delivered via Respimat® inhaler once daily in the evening over 12 weeks, compared to placebo, as add-on controller therapy on top of usual care in children (6 to 11 years old) wi...
What is the current status of trial NCT01634152?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 401 participants. The study started on 2012-07. Estimated completion is 2015-05.
What interventions are being tested in trial NCT01634152?
The interventions under investigation include: Placebo (DRUG), Tiotropium low dose mcg (DRUG), Tiotropium high dose (DRUG).
Who is sponsoring clinical trial NCT01634152?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
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