Effect of Treatment BI 1744 CL (5 and 10 mcg) Versus Placebo on Exercise Endurance Time During Constant Work Rate Cycle Ergometry II

NCT ID: NCT01040793

Last Updated: 2014-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 157 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31

Brief Summary

To compare the effects of BI 1744 CL versus placebo on exercise tolerance after 6 weeks of treatment in patients with Chronic Obstructive Pulmonary Disease.

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

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

Study Groups

Olodaterol (BI 1744) Low

Low dose inhaled orally once daily from the Respimat inhaler

Group Type: EXPERIMENTAL

Olodaterol (BI 1744)

Intervention Type: DRUG

Comparison of low and high dose on exercise endurance time in COPD patients

Olodaterol (BI1744)

Intervention Type: DRUG

Comparison of low and high dose on exercise endurance time in COPD patients

Olodaterol (BI 1744) placebo

Intervention Type: DRUG

Placebo that represents olodaterol

Olodaterol (BI 1744) High

High dose inhaled orally once daily from the Respimat inhaler

Group Type: EXPERIMENTAL

Olodaterol (BI 1744)

Intervention Type: DRUG

Comparison of low and high dose on exercise endurance time in COPD patients

Placebo

Olodaterol (BI 1744) placebo inhaled orally from the Respimat inhaler

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Comparison of low and high dose and placebo on exercise endurance time in COPD patients

Interventions

Olodaterol (BI 1744)

Comparison of low and high dose on exercise endurance time in COPD patients

Intervention Type: DRUG

Olodaterol (BI 1744)

Comparison of low and high dose on exercise endurance time in COPD patients

Intervention Type: DRUG

Placebo

Comparison of low and high dose and placebo on exercise endurance time in COPD patients

Intervention Type: DRUG

Olodaterol (BI1744)

Comparison of low and high dose on exercise endurance time in COPD patients

Intervention Type: DRUG

Olodaterol (BI 1744) placebo

Placebo that represents olodaterol

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Signed informed consent prior to participation.

2. Diagnosis of chronic obstructive pulmonary disease and post-bronchodilator FEV1(Forced Expiratory Volume in 1 sec) <80% of predicted normal and post-bronchodilator FEV1(Forced Expiratory Volume in 1 sec)/FVC of < 70% at Visit 1.

3. Male or female between 40 and 75 years of age.

4. Current or ex-smokers with smoking history of more than 10-pack years.

5. Able to perform technically acceptable pulmonary function tests, multiple exercise tests and able to maintain records.

6. Able to inhale medication in a competent manner from a metered-dose inhaler and Respimat inhaler.

Exclusion Criteria

1. Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with an SGOT >x2 ULN, SGPT >x2 ULN, bilirubin >x2 ULN or creatinine >x2 ULN.

2. Patients with a history of asthma and/or total blood eosinophil count of 600 cells/mm3.

3. Patients with thyrotoxicosis, paroxysmal tachycardia (>100 beats per minute).

4. Patients with a history of myocardial infarction within 1 year of screening visit, unstable or life-threatening cardiac arrhythmia, hospitalization 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, life-threatening pulmonary obstruction, cystic fibrosis, clinically evident bronchiectasis, significant alcohol or drug abuse or contraindications to exercise.

5. Patients who have undergone thoracotomy with pulmonary resection.

6. Patients being treated with oral beta-adrenergics or oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day.

7. Patients who regularly use daytime oxygen for more than one hour per day.

8. Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the screening visit or patients who are currently in a pulmonary rehabilitation program.

9. Patients who have a limitation of exercise performance as a result of factors other than fatigue or exertional dyspnea.

10. Pregnant or nursing women.

11. Women of childbearing potential not using two effective methods of birth control (one barrier and one non-barrier).

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 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

1222.38.4380 Boehringer Ingelheim Investigational Site

Hallein, , Austria

1222.38.4381 Boehringer Ingelheim Investigational Site

Leoben, , Austria

1222.38.32004 Boehringer Ingelheim Investigational Site

Brussels, , Belgium

1222.38.32002 Boehringer Ingelheim Investigational Site

Edegem, , Belgium

1222.38.32001 Boehringer Ingelheim Investigational Site

Leuven, , Belgium

1222.38.32003 Boehringer Ingelheim Investigational Site

Liège, , Belgium

1222.38.1082 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

1222.38.1081 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

1222.38.1083 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

1222.38.1080 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

1222.38.4980 Boehringer Ingelheim Investigational Site

Berlin, , Germany

1222.38.4985 Boehringer Ingelheim Investigational Site

Cologne, , Germany

1222.38.4983 Boehringer Ingelheim Investigational Site

Dortmund, , Germany

1222.38.4984 Boehringer Ingelheim Investigational Site

Großhansdorf, , Germany

1222.38.4981 Boehringer Ingelheim Investigational Site

Kiel, , Germany

1222.38.4986 Boehringer Ingelheim Investigational Site

Koblenz, , Germany

1222.38.7080 Boehringer Ingelheim Investigational Site

Moscow, , Russia

1222.38.7081 Boehringer Ingelheim Investigational Site

Moscow, , Russia

1222.38.7082 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Countries

Austria; Belgium; Canada; Germany; Russia

References

Maltais F, Kirsten AM, Hamilton A, De Sousa D, Voss F, Decramer M. Evaluation of the effects of olodaterol on exercise endurance in patients with chronic obstructive pulmonary disease: results from two 6-week crossover studies. Respir Res. 2016 Jul 6;17(1):77. doi: 10.1186/s12931-016-0389-5.

Reference Type: DERIVED

PMID: 27383762 (View on PubMed)

Other Identifiers

2009-014416-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1222.38

Identifier Type: -

Identifier Source: org_study_id