Health Condition 1: null- Chronic Obstructive Pulmonary Disorder
Conditions
Interventions
Intervention1: Tiotropium+olodaterol 2.5 µg /5 µg combination: Route of administration: Oral inhalation via RESPIMAT inhaler Dosage regimen: 2 inhalations once daily Duration of Therapy: 52 weeks
In
Sponsors
Boehringer Ingelheim India Pvt Ltd
Eligibility
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 COPD [P10-01267] and must meet the following spirometric criteria: Patients must have relatively stable airway obstruction with a post-bronchodilator FEV1 a post-bronchodilator FEV1/FVC predicted normal equations). 3. Male or female patients, 40 years of age or older. 4. Patients must be current or ex-smokers with a smoking history of more than 10 pack years. (see Appendix 10.3 for calculation): Patients who have never smoked cigarettes must be excluded. 5. Patients must be able to • perform technically acceptable pulmonary function tests , • perform technically acceptable PEF measurements, • maintain records (Patient Daily e-Diary) during the study period , • perform all other assessments (e.g. complete self administed questionnaires), as required in the protocol. 6. Patients must be able to inhale medication in a competent manner from the RESPIMAT inhaler
Exclusion criteria
Exclusion criteria: Patients with a significant disease other than COPD Patients with a history of asthma. A diagnosis of thyrotoxicosis A diagnosis of paroxysmal tachycardia (100 beats per minute) (due to the known class side effect profile of Ã?2-agonists). A history of myocardial infarction within 1 year of screening visit (Visit 1). Unstable or life-threatening cardiac arrhythmia. Hospitalization for heart failure within the past year. Patients who regularly use daytime oxygen therapy for more than one hour per day Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to screening visit (Visit 1). Pregnant or nursing women. Women of childbearing potential not using a highly effective method of birth control.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ FEV1 AUC0-3h response â?¢ Trough FEV1 response â?¢ SGRQ (total score) (Combined data from 1237.5 and1237.6) Timepoint: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| The TDI focal score (to measure the effect of tiotropium plus olodaterol combination on patientsâ?? health-related quality of life) is key secondary endpoint (Combined data from 1237.5 and1237.6) Timepoint: 24 weeks | — |
Countries
Australia, Austria, Belgium, Canada, Colombia, Czech Republic, Denmark, Finland, France, Germany, Guatemala, Hungary, India, Japan, Netherlands, New Zealand, Norway, Portugal, Slovakia, South Africa, Spain, Taiwan, United States of America
Contacts
Public ContactShoma Das
Boehringer-Ingelheim India Pvt Ltd
Outcome results
None listed