Health Condition 1: null- severe to very severe Chronic Obstructive Pulmonary Disease
Conditions
Interventions
Intervention1: tiotropium 5 ug and olodaterol 5 ug in fixed dose combination: Respimat Inhaler Tiotropium and Olodaterol each in 5 ug combined as fixed dose combination
Once daily
For 52 weeks
Control
Sponsors
BoehringerIngelheim
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients, 40 years of age or older. 2. All patients must have a diagnosis of COPD and must meet the following spirometric criteria stable airway obstruction with a documented post-bronchodilator FEV1 less than 60% of predicted normal and a post-bronchodilator FEV1/FVC less than 70% at Visit 1 3. Patients with a documented history of at least one moderate to severe COPD exacerbation in the previous 12 months requiring treatment with systemic corticosteroids and/or antibiotics and/or related hospitalization. 4. Investigator should also ascertain that the patient is symptomatically stable as defined by ï?· no evidence of COPD exacerbation requiring use of either antibiotics and/or steroids 4 weeks prior to visit 1 and no evidence of change in their usual COPD medication 4 weeks prior to visit 1 5. Patients must be current or ex-smokers with a smoking history of more than 10 pack years 6. Patients must be able to perform all trial related procedures at the investigator discretion including technically acceptable and eligible pulmonary function test vital status follow-up in case of discontinuation until the predicted exit date and COPD exacerbation interview every 6 weeks in case of premature discontinuation until the predicted exit date
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 put the patient at risk because of participation in the study and influence the results of the study and cause concern regarding the patientâ??s ability to participate in the study. 2. Patients with a, in the opinion of the investigator, clinically relevant abnormal baseline haematology, blood chemistry, urinalysis or creatinine more than 2 times ULN will be excluded regardless of clinical condition 3. Patients with a current documented 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 5. A history of myocardial infarction within 6 months of screening visit. 6. Life-threatening cardiac arrhythmia, as judged by the Investigator. 7. Known active tuberculosis. 8. Any malignancy unless free of disease for at least 5 years however patients with treated basal cell carcinoma or squamous cell skin cancers are allowed. 9. A history of cystic fibrosis. 10. Clinically relevant bronchiectasis, as judged by the Investigator 11. Patients with severe emphysema requiring endobronchial interventions within 6 months prior to screening 5. A history of myocardial infarction within 6 months of screening visit (Visit 1). 6. Life-threatening cardiac arrhythmia, as judged by the Investigator. 7. Known active tuberculosis. 8. Any malignancy unless free of disease for at least 5 years (patients with treated basal cell carcinoma or squamous cell skin cancers are allowed). 9. A history of cystic fibrosis. 10. Clinically relevant bronchiectasis, as judged by the Investigator 11. Patients with severe emphysema requiring endobronchial interventions within 6 months prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint 1. Annualised rate of moderate to severe COPD exacerbation during the treatment period (within 1 day after the last drug administration date) Secondary Endpoint 1. Time to first moderate to severe COPD exacerbation during the treatment period 2. Annualised rate of exacerbation leading to hospitalisation during the treatment period 3. Time to first COPD exacerbations leading to hospitalisation during the treatment period 4. Time to all-cause mortalityTimepoint: Primary Endpoint 52 weeks and 1 day Secondary end point 52 weeks and 1 day | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to first moderate to severe COPD exacerbation during the treatment period 2. Annualised rate of exacerbation leading to hospitalisation during the treatment period 3. Time to first COPD exacerbations leading to hospitalisation during the treatment period 4. Time to all-cause mortalityTimepoint: Primary Endpoint 52 weeks and 1 day | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Italy, Japan, Latvia, Lebanon, Lithuania, Malaysia, Mexico, Montenegro, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, United States of America, Viet Nam
Contacts
Public ContactDr Pratha Gokhale
Boehringer-Ingelheim India Pvt Ltd
Outcome results
None listed