Chronic Obstructive Pulmonary Disease (COPD) MedDRA version: 14.0 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Sponsors
Boehringer Ingelheim Finland Ky
Eligibility
Sex/Gender
All
Inclusion 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, at visit 1: - a post-bronchodilator FEV1 =65 years) yes F.1.3.1 Number of subjects for this age range 150
Exclusion criteria
Exclusion criteria: 1. Patients with a significant disease other than COPD; a significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the study, (ii) influence the results of the study, or (iii) cause concern regarding the patient’s ability to participate in the study 2. Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis 3. Patients with a history of asthma. Patients with any of the following conditions: 4. A diagnosis of thyrotoxicosis 5. A diagnosis of paroxysmal tachycardia (>100 beats per minute) 6. A history of myocardial infarction within 1 year of screening visit 7. Unstable or life-threatening cardiac arrhythmia 8. Hospitalized for heart failure within the past year 9. Known active tuberculosis 10. A malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years (patients with treated basal cell carcinoma are allowed) 11. A history of life-threatening pulmonary obstruction 12. A history of cystic fibrosis 13. Clinically evident bronchiectasis 14. A history of significant alcohol or drug abuse 15. Any contraindications for exercise testing. 16. Patients who have undergone thoracotomy with pulmonary resection (patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion No. 1) 17. Patients being treated with any oral ß-adrenergics 18. Patients being treated with 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 19. 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 20. Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the screening visit (Visit 1) or patients who are currently in a pulmonary rehabilitation program 21. Patients who have a limitation of exercise performance as a result of factors other than fatigue or exertional dyspnoea, such as arthritis in the leg, angina pectoris or claudication or morbid obesity 22. Patients with an endurance time more than 25 minutes during the training (Visit 2) or baseline (Visit 3) constant work rate cycle ergometry 23. Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to screening visit (Visit 1) 24. Patients with known hypersensitivity to ß-adrenergic drugs, anticholinergic drugs, BAC, EDTA or any other component of the RESPIMAT inhalation solution delivery system 25. Pregnant or nursing women 26. Women of childbearing potential not using a highly effective method of birth control. 27. Patients who have previously been randomized in this study or are currently participating in another study 28. Patients who are unable to comply with pulmonary medication restrictions prior to randomization At sites performing the shuttle walk tests, patients with the following criteria will be excluded from the shuttle walk tests: 29. Patients who reach level 12 at the incremental shuttle walk test at visit 1a. 30. Patients with an endurance time more than 15 minutes during the training (Visit 2a) or baseline (visit 3a) endurance shuttle walk test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare the effects of orally inhaled tiotropium + olodaterol fixed dose combination (2.5/5 µg; 5/5 µg) with placebo on exercise tolerance after 12 weeks of treatment in patients with COPD. Exercise tolerance will be assessed by measurement of symptom-limited endurance time during constant work rate cycle ergometry.;Secondary Objective: - to compare the effects of orally inhaled tiotropium + olodaterol fixed dose combination with placebo on symptom-limited endurance time during endurance shuttle walk test after 12 weeks of treatment (subset of patients). - to compare the effects of orally inhaled tiotropium + olodaterol fixed dose with placebo on lung hyperinflation during constant work rate cycle ergometry and endurance shuttle walk test after 12 weeks of treatment. - to compare the effects of orally inhaled tiotropium + olodaterol fixed dose combination (2.5/5 µg; 5/5 µg) with placebo on the intensity of breathing discomfort experienced during constant work rate cycle ergometry and endurance shuttle walk test after 12 weeks of treatment. ;Primary end point(s): endurance time during constant work rate cycle ergometry at 75% Wcap (maximal work capacity). ;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Endurance time during the endurance shuttle walk test at walking speed corresponding to 85% of predicted maximum oxygen consumption (subset of patients) 2. Inspiratory capacity (IC) during constant work rate cycle ergometry 3. Intensity of breathing discomfort (Borg Category-Ratio Scale) during constant work rate cycle ergometry 4. Intensity of breathing discomfort (Borg Category-Ratio Scale) during endurance shuttle walk test (subset of patients) 5. Inspiratory capacity (IC) during endurance shuttle walk test (subset of patients) 6. Intensity of leg discomfort (Borg Category-Ratio Scale) during constant work rate cycle ergometry 7. Intensity of leg discomfort during the endurance shuttle walk test (subset of patients) 8. Locus of symptom limitation during constant work rate cycle ergometry 9. Locus of symptom limitation during the endurance shuttle walk test (subset of patients) 10. FEV1, FVC (trough, 1 hr post-dose) 11. endurance time during constant work rate cycle ergometry (day 1) ;Timepoint(s) of evaluation of this end point: endpoints 1 to 10: at 12 weeks endpoints 2,3,6 and 8 also on day 1 of treatment endpoint 11: on day one of treatment | — |
Countries
Argentina, Canada, Finland, Germany, Hungary, Ireland, Italy, Spain, United Kingdom, United States
Contacts
Public ContactDr Carl Coeck
SCS Boehringer Ingelheim Comm.V
Outcome results
None listed