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NCT01277523 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of 2 Doses of Tiotropium Respimat Compared to Placebo in Adolescents With Severe Persistent Asthma
A Phase 3 study of Asthma, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 392
- Enrollment target
- 20
- Study locations
NCT01277523: Completed Phase 3 study of Asthma, sponsored by Boehringer Ingelheim.
NCT01277523 is a Phase 3 study of Asthma that has completed, run by Boehringer Ingelheim. The registered enrollment target is 392 participants, below the 1,562-participant average among 374 other Asthma trials with a reported enrollment target (75% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01277523, a Phase 3 study of Asthma, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 392 participants
- Enrollment target
- 20
- Study locations
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) over 12 weeks, compared to placebo, as add-on controller therapy on top of usual care in adolescents (12 to 17 years old) with severe persistent asthma. The primary objective of the trial is to demonstrate superiority of tiotropium (5 mcg and possibly 2.5 mcg once daily in the evening) over placebo with regard to the primary pulmonary function endpoint after 12 weeks of treatment. Secondary objectives are to evaluate efficacy of tiotropium with regard to other endpoints, and to evaluate the safety of tiotropium, compared to placebo, as add-on controller therapy on top of usual care in this patient population.
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 12. Measured values presented are actually adjusted means.
Conditions Studied
Interventions
- DRUG placebo
- DRUG tiotropium high dose
- DRUG tiotropium low dose
Study Locations (20)
Other
- 205.456.54002 Boehringer Ingelheim Investigational Site - Capital Federal
- 205.456.54006 Boehringer Ingelheim Investigational Site - Capital Federal
- 205.456.54008 Boehringer Ingelheim Investigational Site - Capital Federal
- 205.456.54005 Boehringer Ingelheim Investigational Site - Mendoza
- 205.456.54003 Boehringer Ingelheim Investigational Site - San Juan Bautista
- 205.456.54004 Boehringer Ingelheim Investigational Site - San Miguel de Tucumán
- 205.456.54009 Boehringer Ingelheim Investigational Site - San Miguel de Tucumán
- 205.456.35902 Boehringer Ingelheim Investigational Site - Plovdiv
- 205.456.35901 Boehringer Ingelheim Investigational Site - Rousse
- 205.456.35903 Boehringer Ingelheim Investigational Site - Sofia
California
- 205.456.01004 Boehringer Ingelheim Investigational Site - Stockton
Illinois
- 205.456.01008 Boehringer Ingelheim Investigational Site - Normal
Maryland
- 205.456.01003 Boehringer Ingelheim Investigational Site - Baltimore
Missouri
- 205.456.01007 Boehringer Ingelheim Investigational Site - Columbia
Nebraska
- 205.456.01002 Boehringer Ingelheim Investigational Site - Bellevue
New York
- 205.456.01001 Boehringer Ingelheim Investigational Site - Rockville Centre
Ohio
- 205.456.01005 Boehringer Ingelheim Investigational Site - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 392 participants |
| Start Date | 2011-01 |
| Est. Completion | 2013-10 |
| Phase | Phase 3 |
What the finished NCT01277523 record still lists
NCT01277523 is an interventional study that assigns participants to a tested intervention. The registered 392 participants enrollment target is mid-sized for trials with a published cap, below the 1,562-participant average among 374 other Asthma trials with a reported enrollment target (75% lower).
The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 3 interventions - of which placebo is the first listed.
NCT01277523 names 20 study sites across 11 states, led by Other, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT01277523 about?
NCT01277523 is a clinical study titled "Efficacy and Safety of 2 Doses of Tiotropium Respimat Compared to Placebo in Adolescents With Severe 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) over 12 weeks, compared to placebo, as add-on controller therapy on top of usual care in adolescents (12 to 17 years old) with severe p...
What is the current status of trial NCT01277523?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 392 participants. The study started on 2011-01. Estimated completion is 2013-10.
What conditions does trial NCT01277523 study?
This clinical trial studies the following conditions: Asthma.
What interventions are being tested in trial NCT01277523?
The interventions under investigation include: placebo (DRUG), tiotropium high dose (DRUG), tiotropium low dose (DRUG).
Who is sponsoring clinical trial NCT01277523?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01277523 being conducted?
This trial has 20 study locations across California, Illinois, Maryland, Missouri, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01277523's enrollment target sits among peer trials
392 98th of 374 higher than 277 of 374 other Asthma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Asthma 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.
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