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Efficacy and Safety of 4 Weeks of Treatment With Orally Inhaled BI1744/Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease (COPD) | Clinical Trials | Clareo Health

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Efficacy and Safety of 4 Weeks of Treatment With Orally Inhaled BI1744/Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Randomised, Double-blind, Cross-over Study to Assess the Efficacy and Safety of 4 Weeks of Once Daily Treatment of 2 Doses of Orally Inhaled BI 1744 CL, Each in Fixed Dose Combination (FDC) With 5 Microgram Tiotropium Bromide (Delivered by the Respimat® Inhaler) in Patients With COPD

NCT00720499•Boehringer Ingelheim

View on ClinicalTrials.gov

Summary

The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL administered with 5 microgram tiotropium bromide solution for inhalation, delivered by the Respimat® inhaler, once daily for four weeks in patients with chronic obstructive pulmonary disease (COPD).

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions
•2. All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:
•Patients must have relatively stable airway obstruction with a post-bronchodilator FEV1 \>= 30% of predicted normal and \<80% of predicted normal and a post-bronchodilator FEV1 / FVC \<70% at Visit 1
•3. Male or female patients, 40 years of age or older
•4. Patients must be current or ex-smokers with a smoking history of more than 10 pack years
•5. Patients must be able to perform technically acceptable pulmonary function tests and PEF measurements, and must be able to maintain records (Patient Daily e-Diary) during the study period as required in the protocol
•6. Patients must be able to inhale medication in a competent manner from the Respimat inhaler and from a metered dose inhaler (MDI).

Exclusion Criteria

•1. Patients with a significant disease other than COPD
•2. Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis;
•3. Patients with a history of asthma or a total blood eosinophil count \>= 600/mm3.
•4. Patients with any of the following conditions:a diagnosis of thyrotoxicosis, a diagnosis of paroxysmal tachycardia (\>100 beats per minute), a marked baseline prolongation of QT/QTc interval (e.g. repeated demonstration of a QTcF\* interval \> 450 ms), a history of additional risk factors for Torsade de Pointes (TdP) (e.g. heart failure, hypokalemia, family history of Long QT Syndrome)
•5. Patients with any of the following conditions:a history of myocardial infarction within 1 year of screening visit (Visit 1), a diagnosis of clinically relevant cardiac arrhythmia, known active tuberculosis, a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years, a history of life-threatening pulmonary obstruction, a history of cystic fibrosis, clinically evident bronchiectasis, a history of significant alcohol or drug abuse
•6. Patients who have undergone thoracotomy with pulmonary resection
•7. Patients who regularly use daytime oxygen therapy for more than one hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy during clinic visits.
•8. Pregnant or nursing women
•9. Women of childbearing potential not using two effective method of birth control (one barrier and one non-barrier). Female patients will be considered to be of childbearing potential unless surgically sterilised by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years
•10. Patients who have previously been randomized in this study or are currently participating in another study
+2 more criteria

Locations (24)

1237.9.00152 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

1237.9.00155 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

1237.9.00151 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

1237.9.00154 Boehringer Ingelheim Investigational Site

Killeen, Texas, United States

1237.9.00153 Boehringer Ingelheim Investigational Site

Spokane, Washington, United States

1237.9.03253 Boehringer Ingelheim Investigational Site

Brussels, Belgium

1237.9.03255 Boehringer Ingelheim Investigational Site

Brussels, Belgium

1237.9.03254 Boehringer Ingelheim Investigational Site

Edegem, Belgium

1237.9.03251 Boehringer Ingelheim Investigational Site

Ghent, Belgium

1237.9.03252 Boehringer Ingelheim Investigational Site

Leuven, Belgium

Key Dates

Start Date

July 1, 2008

Primary Completion Date

February 1, 2009

Last Updated

August 17, 2015

Enrollment

141

ACTUAL participants

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

BI 1744 CL plus tiotropium bromide

DRUG

Respimat® Inhaler

DEVICE

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

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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: August 17, 2015Data 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

Efficacy and Safety of 4 Weeks of Treatment With Orally Inhaled BI1744/Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Inclusion Criteria

Exclusion Criteria

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