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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 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 453 participants.
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.
Interventions
- DRUG placebo
- DRUG tiotropium 5mcg/day
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 453 participants |
| Start Date | 2008-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00776984
The ClinicalTrials.gov registry entry for NCT00776984 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 453 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00776984 reports 0 study locations.
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.
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