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NCT00776984 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 453
- Enrollment target
NCT00776984: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT00776984 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 453 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (41% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00776984, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 453 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Peak FEV1 0-3h response was defined as the difference between the maximum FEV1 measured within the first 3 hours post dosing after a treatment period of 24 weeks and the FEV1 baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.
Interventions
- DRUG placebo
- DRUG tiotropium 5mcg/day
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 453 participants |
| Start Date | 2008-10 |
| Phase | Phase 3 |
What the finished NCT00776984 record still lists
NCT00776984 is an interventional study that assigns participants to a tested intervention. The registered 453 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (41% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00776984 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00776984 about?
NCT00776984 is a clinical study titled "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)". 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 the...
What is the current status of trial NCT00776984?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 453 participants. The study started on 2008-10.
What interventions are being tested in trial NCT00776984?
The interventions under investigation include: placebo (DRUG), tiotropium 5mcg/day (DRUG).
Who is sponsoring clinical trial NCT00776984?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00776984's enrollment target sits among peer trials
453 834th of 2000 higher than 1,166 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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