Chronic Obstructive Pulmonary Disease MedDRA version: 14.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855
Conditions
Sponsors
Boehringer Ingelheim Pharma GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - patients must sign informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions. - Patients must have a diagnosis of COPD and must meet the following spirometric criteria: Patients must have relatively stable airway obstruction with a post-bronchodilator (10 to 45 minutes after 400mcg salbutamol) FEV1>30% and =65 years) yes F.1.3.1 Number of subjects for this age range 18
Exclusion criteria
Exclusion criteria: - Significant disease other than COPD - Clinically relevant abnormal lab values. - History of asthma. - Diagnosis of thyrotoxicosis - Diagnosis of paroxysmal tachycardia - History of myocardial infarction within 1 year of screening visit - Unstable or life-threatening cardiac arrhythmia - Hospitalization for heart failure within the past year - Known active tuberculosis - Malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years - History of life-threatening pulmonary obstruction and patients with chronic respiratory failure - History of cystic fibrosis - Clinically evident bronchiectasis - History of significant alcohol or drug abuse - Thoracotomy with pulmonary resection - Patients treated with oral or patch ß-adrenergics - Patients treated with oral corticosteroid medication at unstable doses or at doses in excess of 10mg prednisolone per day or equivalent - Regular use of daytime oxygen therapy for more than one hour per day - Pulmonary rehabilitation program in the six weeks prior to the screening visit or patients currently in a pulmonary rehabilitation program - Investigational drug within one month or six half lives (whichever is greater) prior to screening visit - Known hypersensitivity to ß-adrenergic and/or anticholinergic drugs, BAC, EDTA - Pregnant or nursing women - Women of childbearing potential not using a highly effective method of birth control - Patient who have previously been randomized in this study or are currently participating in another study - Patients who are unable to comply with pulmonary medication restrictions prior to randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy and Safety of tiotropium/olodaterol fixed dose combination compared to free combination of tiotropium and olodaterol;Secondary Objective: Not applicable;Primary end point(s): 1: FEV1 AUC0-3h response (Response is defined as the change from patient baseline, patient baseline is the average of the mean pre-dose values on each test day) ;Timepoint(s) of evaluation of this end point: 1: 3 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1: Mean QTcF interval change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min) 2: Peak QTcF interval change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min) 3: Mean heart rate change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min) 4: Peak heart rate change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min) ;Timepoint(s) of evaluation of this end point: 1: 50 min 2: 50 min 3: 50 min 4: 50 min | — |
Countries
Germany
Contacts
Public ContactQRPE PSC CT Information Disclosure
Boehringer Ingelheim
Outcome results
None listed