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NCT01179347 · ClinicalTrials.gov registry record · Phase 3
Tiotropium Bromide in Cystic Fibrosis
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 464
- Enrollment target
NCT01179347 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 464 participants.
The verdict
NCT01179347, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 464 participants
- Enrollment target
Study Summary
To date, there have been no formal clinical studies completed using tiotropium in CF patients. While there is a large body of evidence demonstrating the efficacy and safety of tiotropium in patients with Chronic Obstructive Pulmonary Disease (COPD), relatively little is known about its efficacy and safety in patients with a diagnosis of cystic fibrosis. Therefore, Boehringer Ingelheim proposed to profile the long acting anticholinergic tiotropium and to generate adequate clinical data for use as a bronchodilator in paediatric and adult CF. The phase III trial (205.438) is a part of the approved Paediatric Investigation Plan (PIP) agreed for Spiriva® Respimat® in Cystic Fibrosis.
Interventions
- DRUG tiotropium Respimat® inhaler
- DRUG Placebo Respimat® inhaler
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 464 participants |
| Start Date | 2010-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01179347
The ClinicalTrials.gov registry entry for NCT01179347 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 464 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 tiotropium Respimat® inhaler is the first listed.
NCT01179347 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01179347 about?
NCT01179347 is a clinical study titled "Tiotropium Bromide in Cystic Fibrosis". To date, there have been no formal clinical studies completed using tiotropium in CF patients. While there is a large body of evidence demonstrating the efficacy and safety of tiotropium in patients with Chronic Obstructive Pulmonary Disease (COPD), relatively little is known about its efficacy and ...
What is the current status of trial NCT01179347?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 464 participants. The study started on 2010-09.
What interventions are being tested in trial NCT01179347?
The interventions under investigation include: tiotropium Respimat® inhaler (DRUG), Placebo Respimat® inhaler (DRUG).
Who is sponsoring clinical trial NCT01179347?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
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