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

NCT ID: NCT00720499

Last Updated: 2015-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 141 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31

Brief 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).

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BI 1744 CL low dose+tiotropium bromide

BI 1744 CL low dose plus tiotropium bromide fixed dose combination; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation

Group Type: EXPERIMENTAL

BI 1744 CL plus tiotropium bromide

Intervention Type: DRUG

BI 1744 CL plus tiotropium bromide fixed dose combination; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation

Respimat® Inhaler

Intervention Type: DEVICE

BI 1744 CL medium dose+tiotropium bromide

BI 1744 CL medium dose plus tiotropium bromide fixed dose combination; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation

Group Type: EXPERIMENTAL

BI 1744 CL plus tiotropium bromide

Intervention Type: DRUG

BI 1744 CL plus tiotropium bromide fixed dose combination; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation

Respimat® Inhaler

Intervention Type: DEVICE

Interventions

BI 1744 CL plus tiotropium bromide

BI 1744 CL plus tiotropium bromide fixed dose combination; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation

Intervention Type: DRUG

Respimat® Inhaler

Intervention Type: DEVICE

Eligibility Criteria

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

11. Patients who are unable to comply with pulmonary medication restrictions prior to randomization

12. Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to Screening Visit

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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

1237.9.00255 Boehringer Ingelheim Investigational Site

Mississauga, Ontario, Canada

1237.9.00251 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

1237.9.00252 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

1237.9.00254 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

1237.9.00253 Boehringer Ingelheim Investigational Site

Ste-Foy, Quebec, Canada

1237.9.04952 Boehringer Ingelheim Investigational Site

Berlin, , Germany

1237.9.04953 Boehringer Ingelheim Investigational Site

Berlin, , Germany

1237.9.04954 Boehringer Ingelheim Investigational Site

Berlin, , Germany

1237.9.04955 Boehringer Ingelheim Investigational Site

Bruchsal, , Germany

1237.9.04959 Boehringer Ingelheim Investigational Site

Gelnhausen, , Germany

1237.9.04960 Boehringer Ingelheim Investigational Site

Großhansdorf, , Germany

1237.9.04958 Boehringer Ingelheim Investigational Site

Hamburg, , Germany

1237.9.04951 Boehringer Ingelheim Investigational Site

Tübingen, , Germany

1237.9.04956 Boehringer Ingelheim Investigational Site

Wiesloch, , Germany

Countries

United States; Belgium; Canada; Germany

Other Identifiers

EudtaCT No: 2008-000562-23

Identifier Type: -

Identifier Source: secondary_id

1237.9

Identifier Type: -

Identifier Source: org_study_id