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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 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 398 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01257230
The ClinicalTrials.gov registry entry for NCT01257230 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 398 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 tiotropium Respimat low dose is the first listed.
NCT01257230 reports 0 study locations.
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.
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