Chronic Obstructive Pulmonary Disease MedDRA version: 14.1 Level: PT Classification code 10009033 Term: Chronic obstructive pulmonary disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1 Level: LLT Classification code 10009032 Term: Chronic obstructive lung disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Sponsors
Boehringer Ingelheim RCV GmbH & Co KG
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 pulmonarydisease and must meet the following spirometric criteria: Patients must have relatively stable airway obstruction with a postbronchodilator 30% = FEV1 =65 years) yes F.1.3.1 Number of subjects for this age range 280
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; all patients with an SGOT >x2 ULN, SGPT >x2 ULN, bilirubin >x2 ULN or creatinine >x2 ULN will be excluded regardless of clinical condition (a repeat laboratory evaluation will not be conducted in these patients) 3. Patients with a history of asthma. For patients with allergic rhinitis or atopy, source documentation is required to verify that the patient does not have asthma. If a patient has a total blood eosinophil count greater than or equal to 600/mm3, source documentation is required to verify that the increased eosinophil count is related to a non-asthmatic condition. Patients with any of the following conditions: 4. A diagnosis of thyrotoxicosis (due to the known class side effect profile of ß2-agonists) 5. A diagnosis of paroxysmal tachycardia (>100 beats per minute) (due to the known class side effect profile of ß2-agonists) 6. A history of myocardial infarction within 1 year of screening visit (Visit 1) 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 and patients with chronic respiratory failure 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 as outlined in protocol 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 greater than 25 minutes during the training (Visit 1) or baseline constant work rate cycle ergometry at Visit 2 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-adrenergics drugs, anticholinergic drugs, BAC, EDTA or any other component of the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of this study are: 1) To compare the effects of orally inhaled tiotropium + olodaterol fixed dose combination (2.5 / 5 µg ; 5 / 5 µg) with tiotropium (5 µg), olodaterol (5 µg) and placebo on lung hyperinflation during constant work rate exercise in patients with COPD. Lung hyperinflation will be assessed by measurement of inspiratory capacity (IC). 2) To compare the effects of orally inhaled tiotropium + olodaterol fixed dose combination (2.5 / 5 µg ; 5 / 5 µg) with tiotropium (5 µg), olodaterol (5 µg) and placebo on constant work rate exercise tolerance after 6 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: The secondary 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 tiotropium (5 µg), olodaterol (5 µg) and placebo on the intensity of breathing discomfort experienced during constant work rate exercise in patients with COPD. The intensity of breathing discomfort will be rated by the patients using the Borg Category-Ratio Scale.;Primary end point(s): Two primary endpoints are defined: • inspiratory capacity (IC) at isotime during constant work rate cycle ergometry to symptom limitation at 75% Wcap after 6 weeks of treatment. • endurance time during constant work rate cycle ergometry to symptom limitation at 75% Wcap* (maximal work capacity) after 6 weeks of treatment. * Wcap (maximal work capacity) is the maximum work rate achieved for at least 30 seconds during the incremental cycle ergometry performed at Visit 1.;Timepoint(s) of evaluation of this end point: After 6 weeks treatment. For IC, this will be measured at isotime where for each individual subject, isotime is defined as the endurance time of the constant work rate exercise test of shortest duration from Visit 2, Visit 4, Visit 6, V | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The following key secondary endpoint will also be assessed during the constant work rate cycle ergometry: - intensity of breathing discomfort at isotime during constant work rate cycle ergometry to symptom limitation at 75% Wcap after 6 weeks of treatment;Timepoint(s) of evaluation of this end point: After 6 weeks treatment. For BORG breathing discomfort this will be measured at isotime where for each individual subject, isotime is defined as the endurance time of the constant work rate exercise test of shortest duration from Visit 2, Visit 4, Visit 6, Visit 8 and Visit 10. | — |
Countries
Argentina, Australia, Austria, Belgium, Canada, Chile, Germany, Italy, New Zealand, United States
Contacts
Public ContactQRPE PSC CT Information Disclosure
Boehringer Ingelheim Pharma GmbH & Co. KG
Outcome results
None listed