Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
A Randomised, Double-blind, 5 Treatment Arms, 4-period, Incomplete Cross-over Study to Determine the Effect of 6 Weeks Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (FDC) (2.5 / 5 µg; and 5 / 5 µg) (Delivered by the Respimat® Inhaler) Compared With Tiotropium (5 µg), Olodaterol (5 µg ) and Placebo (Delivered by the Respimat® Inhaler) on Lung Hyperinflation and Exercise Endurance Time During Constant Work Rate Cycle Ergometry in Patients With Chronic Obstructive Pulmonary Disease (COPD) [MORACTO TM 1]
The primary objective of this trial is to investigate the effect of 6 weeks treatment with tiotropium + olodaterol fixed dose combination inhalation solution on lung hyperinflation and exercise tolerance in patients with COPD
Status | Completed |
Enrollment | 295 |
Est. completion date | November 2013 |
Est. primary completion date | November 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 75 Years |
Eligibility |
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 <80% of predicted normal and a post-bronchodilator FEV1/FVC <70% at Visit 1. 3. Male or female patients, between 40 and 75 years of age (inclusive) on day of signing informed consent. 4. Patients must be current or ex-smokers with a smoking history of more than 10 pack years. 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 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. 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 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 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 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 who have taken an investigational drug within one month or six half lives (whichever is greater) prior to screening visit 23. Patients with known hypersensitivity to ß-adrenergics drugs, anticholinergic drugs, BAC, EDTA or any other component of the Respimat® inhalation solution delivery system 24. Pregnant or nursing women 25. Women of childbearing potential not using highly effective methods of birth control. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Argentina | 1237.13.54301 Boehringer Ingelheim Investigational Site | Capital Federal | |
Argentina | 1237.13.54302 Boehringer Ingelheim Investigational Site | Mar del Plata | |
Australia | 1237.13.61306 Boehringer Ingelheim Investigational Site | Concord | New South Wales |
Australia | 1237.13.61301 Boehringer Ingelheim Investigational Site | Daw Park | South Australia |
Australia | 1237.13.61304 Boehringer Ingelheim Investigational Site | Footscray | Victoria |
Australia | 1237.13.61302 Boehringer Ingelheim Investigational Site | Prahran | Victoria |
Australia | 1237.13.61305 Boehringer Ingelheim Investigational Site | Toorak Gardens | South Australia |
Austria | 1237.13.43303 Boehringer Ingelheim Investigational Site | Linz | |
Austria | 1237.13.43301 Boehringer Ingelheim Investigational Site | Thalheim bei Wels | |
Belgium | 1237.13.32302 Boehringer Ingelheim Investigational Site | Brussel | |
Belgium | 1237.13.32303 Boehringer Ingelheim Investigational Site | Edegem | |
Belgium | 1237.13.32305 Boehringer Ingelheim Investigational Site | Jambes | |
Belgium | 1237.13.32304 Boehringer Ingelheim Investigational Site | Lanaken | |
Belgium | 1237.13.32301 Boehringer Ingelheim Investigational Site | Leuven | |
Canada | 1237.13.11302 Boehringer Ingelheim Investigational Site | Hamilton | Ontario |
Canada | 1237.13.11303 Boehringer Ingelheim Investigational Site | Kingston | Ontario |
Canada | 1237.13.11304 Boehringer Ingelheim Investigational Site | Saskatoon | Saskatchewan |
Chile | 1237.13.56301 Boehringer Ingelheim Investigational Site | Chile | |
Chile | 1237.13.56302 Boehringer Ingelheim Investigational Site | Santiago de Chile | |
Germany | 1237.13.49302 Boehringer Ingelheim Investigational Site | Berlin | |
Germany | 1237.13.49307 Boehringer Ingelheim Investigational Site | Dortmund | |
Germany | 1237.13.49304 Boehringer Ingelheim Investigational Site | Frankfurt | |
Germany | 1237.13.49301 Boehringer Ingelheim Investigational Site | Halle | |
Germany | 1237.13.49303 Boehringer Ingelheim Investigational Site | Hannover | |
Germany | 1237.13.49305 Boehringer Ingelheim Investigational Site | Lübeck | |
Italy | 1237.13.39302 Boehringer Ingelheim Investigational Site | Genova | |
Italy | 1237.13.39304 Boehringer Ingelheim Investigational Site | Parma | |
Italy | 1237.13.39303 Boehringer Ingelheim Investigational Site | Pavia | |
Italy | 1237.13.39305 Boehringer Ingelheim Investigational Site | Pavullo Nel Frignano (mo) | |
Italy | 1237.13.39301 Boehringer Ingelheim Investigational Site | Pisa | |
Italy | 1237.13.39312 Boehringer Ingelheim Investigational Site | Pisa | |
Italy | 1237.13.39310 Boehringer Ingelheim Investigational Site | Roma | |
Italy | 1237.13.39308 Boehringer Ingelheim Investigational Site | Sesto S. Giovanni (mi) | |
Italy | 1237.13.39306 Boehringer Ingelheim Investigational Site | Trieste | |
New Zealand | 1237.13.64302 Boehringer Ingelheim Investigational Site | Christchurch | |
New Zealand | 1237.13.64301 Boehringer Ingelheim Investigational Site | Greenlane East Auckland NZ | |
United States | 1237.13.01305 Boehringer Ingelheim Investigational Site | Easley | South Carolina |
United States | 1237.13.01301 Boehringer Ingelheim Investigational Site | Greenville | South Carolina |
United States | 1237.13.01308 Boehringer Ingelheim Investigational Site | Hartford | Connecticut |
United States | 1237.13.01304 Boehringer Ingelheim Investigational Site | Livonia | Michigan |
United States | 1237.13.01307 Boehringer Ingelheim Investigational Site | Pittsburgh | Pennsylvania |
United States | 1237.13.01306 Boehringer Ingelheim Investigational Site | Richmond | Virginia |
United States | 1237.13.01303 Boehringer Ingelheim Investigational Site | Spartanburg | South Carolina |
United States | 1237.13.01302 Boehringer Ingelheim Investigational Site | Torrance | California |
Lead Sponsor | Collaborator |
---|---|
Boehringer Ingelheim |
United States, Argentina, Australia, Austria, Belgium, Canada, Chile, Germany, Italy, New Zealand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Inspiratory Capacity at Rest Before Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap | Inspiratory capacity (IC) at rest before constant work rate cycle ergometry to symptom limitation at 75% maximal work capacity (Wcap). Wcap was defined as the maximum work rate achieved for at least 30 seconds during the incremental cycle ergometry performed at Visit 1. The presented means are adjusted means from the MMRM (Mixed Effects Model Repeated Measures) model. |
6 weeks | No |
Primary | Endurance Time During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap | Endurance time during constant work rate cycle ergometry (CWRCE) to symptom limitation at 75% work capacity (Wcap). Wcap was defined as the maximum work rate achieved for at least 30 seconds during the incremental cycle ergometry performed at Visit 1. The presented means are adjusted mean from the MMRM model. |
6 weeks | No |
Secondary | Slope of the Intensity of Breathing Discomfort During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Work Capacity | Slope of the intensity of breathing discomfort during Constant Work Rate Cycle Ergometry (CWRCE) to symptom limitation at 75% Work capacity (Wcap). The intensity of breathing discomfort was rated using the modified Borg scale with ratings from 0 (nothing at all) to 10 (maximal). Slope of breathing discomfort is defined as: (intensity of breathing discomfort at the end of exercise minus intensity of breathing discomfort at rest) / endurance time. A decrease in slope indicates improvement. The presented means are adjusted means from MMRM model. |
6 weeks | No |
Secondary | Forced Expiratory Volume in 1 Second (One Hour Post-dose) | Forced Expiratory Volume in 1 Second (FEV1) (one hour post-dose) The presented means are adjusted means from MMRM model. |
6 weeks | No |
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