Tiotropium Bromide in Cystic Fibrosis
Public ClinicalTrials.gov record NCT01179347. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomised, Double-blind, Placebo-controlled Parallel-group Trial to Confirm the Efficacy After 12 Weeks and the Safety of Tiotropium 5 Mcg Administered Once Daily Via the Respimat® Device in Patients With Cystic Fibrosis.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01179347
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 464 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2010
- Primary completion
- Feb 29, 2012
- Completion
- Not listed
- Last update posted
- Dec 23, 2013
Started 2010
United States locations
- U.S. sites
- 15
- U.S. states
- 11
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 205.438.01004 Boehringer Ingelheim Investigational Site | Tuscon | Arizona | — | — |
| 205.438.01011 Boehringer Ingelheim Investigational Site | San Diego | California | — | — |
| 205.438.01018 Boehringer Ingelheim Investigational Site | Jacksonville | Florida | — | — |
| 205.438.01008 Boehringer Ingelheim Investigational Site | Orlando | Florida | — | — |
| 205.438.01014 Boehringer Ingelheim Investigational Site | Orlando | Florida | — | — |
| 205.438.01021 Boehringer Ingelheim Investigational Site | Orlando | Florida | — | — |
| 205.438.01007 Boehringer Ingelheim Investigational Site | Indianapolis | Indiana | — | — |
| 205.438.01006 Boehringer Ingelheim Investigational Site | South Bend | Indiana | — | — |
| 205.438.01001 Boehringer Ingelheim Investigational Site | Detroit | Michigan | — | — |
| 205.438.01010 Boehringer Ingelheim Investigational Site | Manchester | New Hampshire | — | — |
| 205.438.01003 Boehringer Ingelheim Investigational Site | Syracuse | New York | — | — |
| 205.438.01019 Boehringer Ingelheim Investigational Site | Cleveland | Ohio | — | — |
| 205.438.01013 Boehringer Ingelheim Investigational Site | Oklahoma City | Oklahoma | — | — |
| 205.438.01005 Boehringer Ingelheim Investigational Site | Charleston | South Carolina | — | — |
| 205.438.01012 Boehringer Ingelheim Investigational Site | Milwaukee | Wisconsin | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 84 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01179347, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 23, 2013 · Synced Sep 25, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01179347 live on ClinicalTrials.gov.