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12 / 48 Week Pivotal PFT vs PBO in COPD I | Clinical Trials | Clareo Health

COMPLETEDPHASE3

12 / 48 Week Pivotal PFT vs PBO in COPD I

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)

NCT00782210•Boehringer Ingelheim

View on ClinicalTrials.gov

Summary

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). The safety of BI 1744 CL inhalation solution delivered through the Respimat inhaler will also be compared to placebo.

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

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 Post bronchodilator FEV1 \<80% predicted and post-bronchodilator FEV1/FVC \<70%

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

Locations (54)

1222.11.1122 Boehringer Ingelheim Investigational Site

Jasper, Alabama, United States

1222.11.1116 Boehringer Ingelheim Investigational Site

Berkeley, California, United States

1222.11.1121 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

1222.11.1111 Boehringer Ingelheim Investigational Site

Fort Collins, Colorado, United States

1222.11.1117 Boehringer Ingelheim Investigational Site

Stamford, Connecticut, United States

1222.11.1110 Boehringer Ingelheim Investigational Site

DeLand, Florida, United States

1222.11.1106 Boehringer Ingelheim Investigational Site

Coeur d'Alene, Idaho, United States

1222.11.1108 Boehringer Ingelheim Investigational Site

Evansville, Indiana, United States

1222.11.1109 Boehringer Ingelheim Investigational Site

Bowling Green, Kentucky, United States

1222.11.1113 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Key Dates

Start Date

November 1, 2008

Primary Completion Date

September 1, 2010

Last Updated

June 9, 2014

Enrollment

625

ACTUAL participants

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Olodaterol (BI1744)

DRUG

Olodaterol (BI1744)

DRUG

placebo

DRUG

Digital Implementation of the German S3 Clinical Practice Guideline for Multimorbidity

NCT06831994

Asthma BronchialeBreast Neoplasms+11 more

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RECRUITING

The London COPD Exacerbation Cohort

NCT02755974

Pulmonary Disease, Chronic Obstructive

View study

ACTIVE_NOT_RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 9, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

12 / 48 Week Pivotal PFT vs PBO in COPD I

Inclusion Criteria

Exclusion Criteria

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