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Study Name: Effect of Tiotropium Bromide (Spiriva) in People with CF
Study Type: Interventional
Intervention Category: Other
Study Sponsor: BI
Study Phase: 2
Recruitment Status: Trial Completed
Study Drug(s): Tiotropium Bromide
Number of Participants Being Recruited: 465
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
Tiotropium bromide (Spiriva) is an inhaled medication taken once a day that helps the smooth muscle surrounding the airways of the lungs relax. This study looked at the safety and use of tiotropium bromide (Sprivia) inhaled once a day for 12 weeks. The study had 2 groups with each taking a different dose of tiotropium bromide. People in the study were asked to do pulmonary lung function tests to see if the medication helps lung function in patients with Cystic Fibrosis.
ELIGIBILITY
Age: >= 5 Years
FEV1: >= 25 Percent Predicted
P. aeruginosa status: Not applicable
B. cepacia status: Not applicable
Other Primary Eligibility Requirements:

Note: Detailed eligibility criteria information may be available on clinicaltrials.gov. If a specific trial listing for this trial is available, a link to the specific clinicaltrials.gov listing will be present in the "More Information" section below.
FOR MORE INFORMATION:
Sponsor Contact Information: Koker, Paul
(203) 798-4489
pkoker@rdg.boehringer-ingelheim.com
Trial Specific Link on ClinicalTrials.gov: http://clinicaltrials.gov/ct2/show/NCT00737100?term=205.339+AND+cystic+fibrosis&rank=1
Clinical Research Terms Glossary: Click here
TRIAL RESULTS:
Primary Efficacy:

Five hundred ten pediatric and adult subjects with CF were enrolled in this randomized, placebo-controlled, Phase 2b study to evaluate safety and efficacy of a 12-week treatment with 2 doses tiotropium bromide inhaled once daily (2.5 µg or 5.0 µg) compared to placebo.
Both dose levels of tiotropium showed statistically significant improvement in bronchodilation compared to placebo for the co-primary efficacy endpoints of %predicted FEV1 AUC0-4h response and %predicted trough FEV1 at the end of Week 12.

Secondary Efficacy:

At the end of Week 12, there was a statistically significant improvement in bronchodilation for FVC AUC0-4h at the 5ug dose and for %predicted pre-bronchodilator FEF25-75. The results of CFQ scores did not show a treatment benefit with tiotropium at the end of Week 12.

Safety:

Both doses of tiotropium were well tolerated with no unexpected adverse events. Adverse events were equally distributed across groups and primarily respiratory-related.

The summary of data provided here is from sponsor information posted on ClinicalTrials.gov. These data have not been peer-reviewed.

Citation:

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