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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: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT01179347 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 464 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Mixed Model Repeated Measurement (MMRM) results. Response was defined as change from baseline in percent of predicted at the end of 12-week double-blind treatment period and is therefore expressed in percent of predicted. Means are adjusted for treatment, visit, treatment-by-visit interaction, age group (\<= 11, \>=12), baseline and baseline-by-visit interaction. FEV1 AUC0-4h was normalised for time and was calculated using the trapezoidal rule divided by the observation time (4 h).
Interventions
- DRUG tiotropium Respimat® inhaler
- DRUG Placebo Respimat® inhaler
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 464 participants |
| Start Date | 2010-09 |
| Phase | Phase 3 |
What the finished NCT01179347 record still lists
NCT01179347 is an interventional study that assigns participants to a tested intervention. The registered 464 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 (40% lower).
The record links to 0 conditions, and to 2 interventions - of which tiotropium Respimat® inhaler is the first listed.
NCT01179347 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01179347's enrollment target sits among peer trials
464 821st of 2000 higher than 1,180 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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