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NCT01122680 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of 3 Doses of Tiotropium Compared to Placebo in Adolescents (12 to 17 Yrs) With Moderate Asthma
A Phase 2 study of Asthma, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 105
- Enrollment target
- 19
- Study locations
NCT01122680: Completed Phase 2 study of Asthma, sponsored by Boehringer Ingelheim.
NCT01122680 is a Phase 2 study of Asthma that has completed, run by Boehringer Ingelheim. The registered enrollment target is 105 participants, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (93% lower). The trial reports 19 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01122680, a Phase 2 study of Asthma, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 105 participants
- Enrollment target
- 19
- Study locations
Study Summary
The primary objective of this trial is to evaluate the efficacy and safety of tiotropium 1.25 mcg (2 actuations of 0.625 mcg), tiotropium 2.5 mcg (2 actuations of 1.25 mcg) and tiotropium 5 mcg (2 actuations of 2.5 mcg) once daily in the evening delivered by the Respimat inhaler in adolescents (12 to 17 yrs) with moderate persistent asthma, compared to placebo and on top of maintenance therapy with an inhaled corticosteroid controller medication. It is a randomised, double-blind, placebo-controlled Phase II trial with incomplete cross-over design. Patients need to be still symptomatic, i. e. not fully controlled with their maintenance treatment.
Primary Outcome
The FEV1 peak (0-3h) response is determined at the end of the 4 week treatment period. This is the difference between the maximum FEV1 measured within the first 3 hours post dosing and the FEV1 baseline measurement. Analysis adjusted for treatment, period, patient and baseline using a mixed model.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG tiotropium bromide
- DRUG Tiotropium bromide
Study Locations (19)
Other
- 205.424.49007 Boehringer Ingelheim Investigational Site - Koblenz
- 205.424.49004 Boehringer Ingelheim Investigational Site - Rosenheim
- 205.424.49002 Boehringer Ingelheim Investigational Site - Wesel
- 205.424.37104 Boehringer Ingelheim Investigational Site - Balvi
- 205.424.37103 Boehringer Ingelheim Investigational Site - Daugavpils
- 205.424.37105 Boehringer Ingelheim Investigational Site - Rēzekne
- 205.424.37101 Boehringer Ingelheim Investigational Site - Riga
- 205.424.37102 Boehringer Ingelheim Investigational Site - Riga
- 205.424.37001 Boehringer Ingelheim Investigational Site - Vilnius
- 205.424.37003 Boehringer Ingelheim Investigational Site - Vilnius
- 205.424.37004 Boehringer Ingelheim Investigational Site - Vilnius
- 205.424.38604 Boehringer Ingelheim Investigational Site - Kamnik
- 205.424.38605 Boehringer Ingelheim Investigational Site - Ljubljana
- 205.424.38602 Boehringer Ingelheim Investigational Site - Maribor
Missouri
- 205.424.01006 Boehringer Ingelheim Investigational Site - Columbia
- 205.424.01007 Boehringer Ingelheim Investigational Site - Warrensburg
Colorado
- 205.424.01002 Boehringer Ingelheim Investigational Site - Denver
Nebraska
- 205.424.01004 Boehringer Ingelheim Investigational Site - Boys Town
Ohio
- 205.424.01001 Boehringer Ingelheim Investigational Site - Canton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2010-05 |
| Phase | Phase 2 |
What the finished NCT01122680 record still lists
NCT01122680 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (93% 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.
NCT01122680 lists 19 locations in 5 states (Other, Missouri, Colorado).
Frequently Asked Questions
What is clinical trial NCT01122680 about?
NCT01122680 is a clinical study titled "Efficacy and Safety of 3 Doses of Tiotropium Compared to Placebo in Adolescents (12 to 17 Yrs) With Moderate Asthma". The primary objective of this trial is to evaluate the efficacy and safety of tiotropium 1.25 mcg (2 actuations of 0.625 mcg), tiotropium 2.5 mcg (2 actuations of 1.25 mcg) and tiotropium 5 mcg (2 actuations of 2.5 mcg) once daily in the evening delivered by the Respimat inhaler in adolescents (12 t...
What is the current status of trial NCT01122680?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 105 participants. The study started on 2010-05.
What conditions does trial NCT01122680 study?
This clinical trial studies the following conditions: Asthma.
What interventions are being tested in trial NCT01122680?
The interventions under investigation include: Placebo (DRUG), tiotropium bromide (DRUG), Tiotropium bromide (DRUG).
Who is sponsoring clinical trial NCT01122680?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01122680 being conducted?
This trial has 19 study locations across Colorado, Missouri, Nebraska, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Asthma
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 NCT01122680's enrollment target sits among peer trials
105 209th of 374 higher than 165 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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