12 / 48 wk Pivotal PFT vs PBO in COPD II

This study is not yet open for participant recruitment.

Verified by Boehringer Ingelheim Pharmaceuticals, December 2008

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00782509

Purpose

This primary objective of this study is to compare two doses of BI 1744 CL inhalation solution delivered by the Respimat® inhaler once daily to placebo in patients with chronic obstructive pulmonary disease (COPD).

Condition	Intervention	Phase
Pulmonary Disease, Chronic Obstructive	Drug: BI 1744 CL	Phase III

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of 48 Weeks of Once Daily Treatment of Orally Inhaled BI 1744 CL (5 Mcg [2 Actuations of 2.5 Mcg] and 10 Mcg [2 Actuations of 5 Mcg]) Delivered by the Respimat® Inhaler, in Patients With Chronic Obstructive Pulmonary Disease (COPD

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

The bronchodilator efficacy of BI 1744 CL will be primarily assessed using forced expiratory volume in one second (FEV1). The 2 co primary endpoints in this study are FEV1 AUC 0 3 response and trough FEV1 response. [ Time Frame: 12 weeks ]

Secondary Outcome Measures:

FEV1 AUC response after 2, 6, 24 and 48 weeks FEV1 trough after 2, 6, 18, 24, 32, 40 and 48 weeks FEV1 peak [ Time Frame: 48 weeks ]

Estimated Enrollment:	510
Study Start Date:	December 2008
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All patients must have a diagnosis of chronic obstructive pulmonary disease
Male or female patients, 40 years of age or older
Patients must be current or ex-smokers with a smoking history of more than 10 pack years

Exclusion Criteria:

Patients with a significant disease other than COPD
Patients with a history of asthma
Patients with any of the following conditions:
a history of myocardial infarction within 1 year of screening visit (Visit 1) unstable or life-threatening cardiac arrhythmia.
have been hospitalized for heart failure within the past year.
known active tuberculosis
a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years (patients with treated basal cell carcinoma are allowed)
a history of life-threatening pulmonary obstruction
a history of cystic fibrosis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00782509

Contacts

Contact: Boehringer Ingelheim Study Coordinator

800-542-6257 ext Option 4

clintriage.rdg@boehringer-ingelheim.com

Show 34 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:	1222.12
Study First Received:	October 29, 2008
Last Updated:	December 10, 2008
ClinicalTrials.gov Identifier:	NCT00782509
Health Authority:	China: State Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices; Taiwan: Department of Health, Executive Yuan, Taiwan; United States: Food and Drug Administration

Study placed in the following topic categories:

Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases

Respiration Disorders
Chronic Disease
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009