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NCT01257230 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of 2 Doses of Tiotropium Via Respimat Compared to Placebo in Adolescents With Moderate Persistent Asthma
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 398
- Enrollment target
NCT01257230: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT01257230 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 398 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
NCT01257230, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 398 participants
- Enrollment target
Study Summary
The aim of the study is to evaluate efficacy and safety of a 48-week treatment with two doses of tiotropium bromide compared to placebo in adolescent patients with moderate persistent asthma. Efficacy and safety will be assessed by measuring lung function parameters and evaluating the effects on asthma exacerbations, on Quality of life, on health care resource utilisation an on the number of adverse events.
Primary Outcome
Change from baseline in peak Forced expiratory volume in 1 second within the first 3 hours post dosing (FEV1 peak0-3) measured at week 24. Note, the measured values presented are actually adjusted means.
Interventions
- DRUG tiotropium Respimat low dose
- DRUG placebo Respimat
- DRUG tiotropium Respimat high dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 398 participants |
| Start Date | 2010-12 |
| Est. Completion | 2013-12 |
| Phase | Phase 3 |
What the finished NCT01257230 record still lists
NCT01257230 is an interventional study that assigns participants to a tested intervention. The registered 398 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 tiotropium Respimat low dose is the first listed.
NCT01257230 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01257230 about?
NCT01257230 is a clinical study titled "Efficacy and Safety of 2 Doses of Tiotropium Via Respimat Compared to Placebo in Adolescents With Moderate Persistent Asthma". The aim of the study is to evaluate efficacy and safety of a 48-week treatment with two doses of tiotropium bromide compared to placebo in adolescent patients with moderate persistent asthma. Efficacy and safety will be assessed by measuring lung function parameters and evaluating the effects on ast...
What is the current status of trial NCT01257230?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 398 participants. The study started on 2010-12. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01257230?
The interventions under investigation include: tiotropium Respimat low dose (DRUG), placebo Respimat (DRUG), tiotropium Respimat high dose (DRUG).
Who is sponsoring clinical trial NCT01257230?
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 NCT01257230's enrollment target sits among peer trials
398 963rd of 2000 higher than 1,037 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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