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NCT01634139 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of 2 Doses of Tiotropium Respimat® Compared to Placebo in Children With Moderate Persistent Asthma
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 403
- Enrollment target
NCT01634139: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT01634139 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 403 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01634139, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 403 participants
- Enrollment target
Study Summary
The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat® inhaler (2.5 mcg and 5 mcg once daily in the evening) over 48 weeks, compared to placebo, in children (6 to 11 years old) with moderate persistent asthma.
Primary Outcome
Change from baseline in peak forced expiratory volume (FEV) in 1 second within the first 3 hours (h) post dosing (FEV1 peak(0-3h)) measured at week 24. Measured values presented are actually adjusted means. The number of participants analysed displays the number of participants with available data at the timepoint of interest.
Interventions
- DRUG Placebo
- DRUG Tiotropium low dose QD
- DRUG Tiotropium high dose QD
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 403 participants |
| Start Date | 2012-07 |
| Est. Completion | 2015-12 |
| Phase | Phase 3 |
What the finished NCT01634139 record still lists
NCT01634139 is an interventional study that assigns participants to a tested intervention. The registered 403 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01634139 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01634139 about?
NCT01634139 is a clinical study titled "Efficacy and Safety of 2 Doses of Tiotropium Respimat® Compared to Placebo in Children With Moderate Persistent Asthma". The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat® inhaler (2.5 mcg and 5 mcg once daily in the evening) over 48 weeks, compared to placebo, in children (6 to 11 years old) with moderate persistent asthma.
What is the current status of trial NCT01634139?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 403 participants. The study started on 2012-07. Estimated completion is 2015-12.
What interventions are being tested in trial NCT01634139?
The interventions under investigation include: Placebo (DRUG), Tiotropium low dose QD (DRUG), Tiotropium high dose QD (DRUG).
Who is sponsoring clinical trial NCT01634139?
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 NCT01634139's enrollment target sits among peer trials
403 917th of 2000 higher than 1,082 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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