study to evaluate the effect on lung function and ecg when a combination of tiotropium plus olodaterol is administered to patients with copd either from a single inhaler or each compound is administered after each other from two different inhalers

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the primary objective of this study is to evaluate the efficacy and safety of orally inhaled tiotropium and olodaterol as both a fixed dose combination and a free combination with respect to lung function and ecg parameters


Eligibility 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 \< 80% of predicted normal (ecsc, gold ii - iii) and a post-bronchodilator fev1/fvc \<70% at visit 1 * male or female patients, 40 years of age or older. * patients must be current or ex-smokers with a smoking history of more than 10 pack years. * patients who have never smoked cigarettes must be excluded. * patients must be able to perform technically acceptable pulmonary function tests according to ats/ers guidelines and maintain records in a paper diary * patients must be able to inhale medication in a competent manner from the respimat inhaler and from a metered dose inhaler (mdi). 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