Safety and Efficacy of 12-wk Treatment With Two Doses of Tiotropium Respimat in Cystic Fibrosis

This study is currently recruiting participants.

Verified by Boehringer Ingelheim Pharmaceuticals, December 2008

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00737100

Purpose

This study evaluates the effects of 12-week treatment with two doses of tiotropium bromide (2.5 mcg q.d. and 5 mcg q.d.) compared to placebo administered via the Respimat device on lung function in patients with Cystic Fibrosis. The selection of the optimal dose will be based on bronchodilator efficacy, safety evaluations and pharmacokinetic evaluations

Condition	Intervention	Phase
Cystic Fibrosis	Drug: tiotropium respimat Drug: placebo	Phase II

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

Drug Information available for: Tiotropium Tiotropium bromide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Investigate the Safety and Efficacy of Two Doses of Tiotropium Bromide (2.5 Mcg and 5 Mcg) Administered Once Daily Via the Respimat Device for 12 Weeks in Patients With Cystic Fibrosis.

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

The coprimary endpoints for this trial are: Change from baseline in FEV1 AUC at the end of week 12 Change from baseline in trough FEV1 at the end of week 12 [ Time Frame: 12 weeks ]

Secondary Outcome Measures:

Change from baseline in FVC AUC at the end of week 12 Change from baseline in trough FVC Change from baseline in prebronchodilator FEF25 to 75 percent predicted at the end of week 12 Proportion of patients with at least 1 pulmonary exacerbation [ Time Frame: 12 weeks ]

Estimated Enrollment:	490
Study Start Date:	September 2008
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female patients
Diagnosis of Cystic Fibrosis (positive sweat chloride test or two identifiable mutations)
Pre-bronchodilator FEV1 greater/equal 25% of predicted values

Exclusion Criteria:

Significant history of allergy/hypersensitivity
Hypersensitivity to study drug
Participation in another trial
Female patients who are pregnant or lactating
Female patients of childbearing potential
Patients who have started a new medication for CF within 4 weeks of screening
Patients with known substance abuse
Clinically significant disease other than CF

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00737100

Contacts

Contact: Boehringer Ingelheim Study Coordinator

800-542-6257 ext Option 4

clintriage.rdg@boehringer-ingelheim.com

Show 84 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

Responsible Party:	Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers:	205.339
Study First Received:	August 15, 2008
Last Updated:	December 10, 2008
ClinicalTrials.gov Identifier:	NCT00737100
Health Authority:	Australia: Responsilble Ethics Committee / Therapeutic Goods Administration; Belgium: Federal Agency for Medicines and Health Products; France: French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Great Britain: MHRA; Netherlands: Central Committee on Research involving human subjects (CCMO); New Zealand: Multicentre Ethics Committee/Medsafe; United States: Food and Drug Administration

Study placed in the following topic categories:

Digestive System Diseases
Genetic Diseases, Inborn
Respiratory Tract Diseases
Cystic Fibrosis
Bromides
Fibrosis

Lung Diseases
Infant, Newborn, Diseases
Pancreatic Diseases
Tiotropium
Cystic fibrosis

Additional relevant MeSH terms:

Parasympatholytics
Respiratory System Agents
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Asthmatic Agents

Cholinergic Agents
Pharmacologic Actions
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009