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A Randomized, Double-Blind, 4-way Crossover Study to Evaluate the Efficacy of of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Randomized, Double-Blind, 4-way Crossover Study to Evaluate the Efficacy of of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease

Randomised, Double-blind, Double-dummy, Placebo-controlled, 4-way Cross-over Study to Characterise the 24-hour FEV1-time Profiles of BI 1744 CL 5μg and 10μg (Oral Inhalation, Delivered by the Respimat® Inhaler) and Tiotropium Bromide 18μg (Oral Inhalation, Delivered by the HandiHaler®) After 6 Weeks of Treatment in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT01040728•Boehringer Ingelheim

View on ClinicalTrials.gov

Summary

The study is intended to characterize the lung function profile of BI1744 in Chronic Obstructive Pulmonary Disease (COPD) patients where patients will perform pulmonary function tests at regular intervals for 24 hours at the end of a 6 week treatment period. Each patient will receive all four treatments.

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients willing to participate with confirmed diagnosis of COPD
•40 years of age or older
•having a 10 pack year smoking history
•able to perform serial pulmonary function tests
•able to use both a Dry powder inhaler (DPI) and Respimat device

Exclusion Criteria

•Significant other disease
•clinically relevant abnormal hematology, chemistry, or urinalysis
•history of asthma
•diagnosis of thyrotoxicosis
•paroxysmal tachycardia related to beta agonists
•history of MI within 1 year, cardiac arrhythmia, hospitalization for heart failure within 1 year
•active tuberculosis, cystic fibrosis, clinically evident bronchiectasis
•significant alcohol or drug abuse
•pulmonary resection
•taking oral beta adrenergics
+6 more criteria

Locations (12)

1222.40.11003 Boehringer Ingelheim Investigational Site

Jasper, Alabama, United States

1222.40.11001 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

1222.40.11002 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

1222.40.49401 Boehringer Ingelheim Investigational Site

Berlin, Germany

1222.40.49403 Boehringer Ingelheim Investigational Site

Berlin, Germany

1222.40.49402 Boehringer Ingelheim Investigational Site

Hanover, Germany

1222.40.31003 Boehringer Ingelheim Investigational Site

Breda, Netherlands

1222.40.31002 Boehringer Ingelheim Investigational Site

Eindhoven, Netherlands

1222.40.31001 Boehringer Ingelheim Investigational Site

Heerlen, Netherlands

1222.40.47003 Boehringer Ingelheim Investigational Site

Arendal, Norway

Key Dates

Start Date

January 1, 2010

Primary Completion Date

January 1, 2011

Last Updated

June 30, 2014

Enrollment

122

ACTUAL participants

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Olodaterol (BI1744) Low

DRUG

Olodaterol (BI1744) High

DRUG

Tiotropium 18 mcg

DRUG

Placebo (for Olodaterol (BI1744)l)

DRUG

Placebo (for Tiotropium)

DRUG

Digital Implementation of the German S3 Clinical Practice Guideline for Multimorbidity

NCT06831994

Asthma BronchialeBreast Neoplasms+11 more

View study

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 30, 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

A Randomized, Double-Blind, 4-way Crossover Study to Evaluate the Efficacy of of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease

Inclusion Criteria

Exclusion Criteria

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