Efficacy and Safety of 2 Doses of Tiotropium Respimat Compared to Placebo in Adolescents With Severe Persistent Asthma
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This page only displays public information reproduced from the official ClinicalTrials.gov record NCT01277523. It adds no medical advice, opinions, or eligibility judgments. The official record remains the source of truth for eligibility criteria, enrollment, and contact information.
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Official title
A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution Delivered Via Respimat® Inhaler (2.5 mcg and 5 mcg Once Daily) Over 12 Weeks as add-on Controller Therapy on Top of Usual Care in Adolescents (12 to 17 Years Old) With Severe Persistent Asthma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01277523
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 392 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 2011 (Type not available)
- Primary completion
- Oct 2013 (Actual)
- Completion
- Oct 2013 (Actual)
- Last update posted
- Oct 20, 2014
2011 – 2013
United States locations
- U.S. sites
- 8
- U.S. states
- 8
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 205.456.01004 Boehringer Ingelheim Investigational Site | Stockton | California | — | — |
| 205.456.01008 Boehringer Ingelheim Investigational Site | Normal | Illinois | — | — |
| 205.456.01003 Boehringer Ingelheim Investigational Site | Baltimore | Maryland | — | — |
| 205.456.01007 Boehringer Ingelheim Investigational Site | Columbia | Missouri | — | — |
| 205.456.01002 Boehringer Ingelheim Investigational Site | Bellevue | Nebraska | — | — |
| 205.456.01001 Boehringer Ingelheim Investigational Site | Rockville Centre | New York | — | — |
| 205.456.01005 Boehringer Ingelheim Investigational Site | Cincinnati | Ohio | — | — |
| 205.456.01006 Boehringer Ingelheim Investigational Site | Summerville | South Carolina | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 61 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01277523, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 20, 2014 · Synced Nov 12, 2026
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