Evaluation of Tiotropium 5 µg/Day Delivered Via the Respimat® Inhaler Over 48 Weeks in Patients With Severe Persistent Asthma on Top of Usual Care (Study II)
Public ClinicalTrials.gov record NCT00776984. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution Delivered Via Respimat® Inhaler (5 mcg/Day) Over 48 Weeks as add-on Controller Therapy on Top of Usual Care in Patients With Severe Persistent Asthma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The trial is a randomised, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of 5 µg tiotropium over a 48-week treatment period as compared to placebo. Tiotropium inhalation solution delivered by the Respimat® inhaler will be examined as add-on controller therapy on top of usual care in patients with severe persistent asthma. The primary objective of each trial is to evaluate the long term efficacy of tiotropium over placebo on top of usual care in patients with severe persistent asthma as determined by pulmonary function testing, effects on asthma exacerbations, effects on quality of life, on asthma control and health care resource utilisation. The secondary objective of each trial is to compare the long term safety of tiotropium with placebo in this patient population.
Study identification
- NCT ID
- NCT00776984
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 453 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 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
- Sep 30, 2008
- Primary completion
- Jun 30, 2011
- Completion
- Not listed
- Last update posted
- Sep 9, 2014
Started 2008
United States locations
- U.S. sites
- 18
- U.S. states
- 13
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 205.417.01061 Boehringer Ingelheim Investigational Site | Fountain Valley | California | — | — |
| 205.417.01052 Boehringer Ingelheim Investigational Site | Fresno | California | — | — |
| 205.417.01051 Boehringer Ingelheim Investigational Site | Stockton | California | — | — |
| 205.417.01056 Boehringer Ingelheim Investigational Site | Waterbury | Connecticut | — | — |
| 205.417.01065 Boehringer Ingelheim Investigational Site | Pensacola | Florida | — | — |
| 205.417.01059 Boehringer Ingelheim Investigational Site | Chicago | Illinois | — | — |
| 205.417.01068 Boehringer Ingelheim Investigational Site | Normal | Illinois | — | — |
| 205.417.01063 Boehringer Ingelheim Investigational Site | Louisville | Kentucky | — | — |
| 205.417.01064 Boehringer Ingelheim Investigational Site | New Orleans | Louisiana | — | — |
| 205.417.01066 Boehringer Ingelheim Investigational Site | Omaha | Nebraska | — | — |
| 205.417.01069 Boehringer Ingelheim Investigational Site | Ocean City | New Jersey | — | — |
| 205.417.01062 Boehringer Ingelheim Investigational Site | Albany | New York | — | — |
| 205.417.01058 Boehringer Ingelheim Investigational Site | Great Neck | New York | — | — |
| 205.417.01055 Boehringer Ingelheim Investigational Site | Rockville Centre | New York | — | — |
| 205.417.01067 Boehringer Ingelheim Investigational Site | High Point | North Carolina | — | — |
| 205.417.01070 Boehringer Ingelheim Investigational Site | Canton | Ohio | — | — |
| 205.417.01053 Boehringer Ingelheim Investigational Site | Upland | Pennsylvania | — | — |
| 205.417.01054 Boehringer Ingelheim Investigational Site | Richmond | Virginia | — | — |
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 57 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00776984, 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 Sep 9, 2014 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00776984 live on ClinicalTrials.gov.