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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.

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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

FieldValue
Enrollment Target 464 participants
Start Date 2010-09
Phase Phase 3

Sponsor

Boehringer Ingelheim

515 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.