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

Boehringer Ingelheim151 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

151

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Olodaterol (BI 1744)DRUG

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

Olodaterol (BI 1744)DRUG

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

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

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).

Locations (19)

1222.37.6171 Boehringer Ingelheim Investigational Site

Daw Park, South Australia, Australia

Outcomes

Primary Outcomes

Adjusted Mean Endurance Time After 6 Weeks

Primary endpoint was endurance time during constant work rate ergometry to symptom limitation at 75% of maximal work capacity after 6 weeks of treatment. Mixed effects model on log10 transformation data. Adjusted means are back transformed to report as geometric means. Standard errors (SEs) are calculated using the delta method.

Time frame: 6 weeks

Secondary Outcomes

Adjusted Mean Inspiratory Capacity at Isotime After 6 Weeks

Isotime is defined as the endurance time of the constant work rate exercise test of shortest duration from Baseline visit, and Week 6 of each of the three treatment periods.

Time frame: 6 weeks

Adjusted Mean Borg Scale of Breathing Discomfort at Isotime After 6 Weeks

Isotime is defined as the endurance time of the constant work rate exercise test of shortest duration from Baseline visit, and Week 6 of each of the three treatment periods. Borg scale rates discomfort with breathing at rest, during exercise and at end-exercise on a scale from 0=Nothing at all to 10=Maximal discomfort.

Time frame: 6 weeks

Adjusted Mean Inspiratory Capacity at Pre-exercise After 6 Weeks

Time frame: 6 weeks

Adjusted Mean Inspiratory Capacity at End of Exercise After 6 Weeks

Time frame: 6 weeks

Adjusted Mean Borg Scale of Breathing Discomfort at Pre-exercise After 6 Weeks

Borg scale rates discomfort with breathing at rest, during exercise and at end-exercise on a scale from 0=Nothing at all to 10=Maximal discomfort.

Time frame: 6 weeks

Adjusted Mean Borg Scale of Breathing Discomfort at End of Exercise After 6 Weeks

Data from ClinicalTrials.gov

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