A Study to Determine the Effect of Tiotropium + Olodaterol Fixed Dose Combination on Exercise Endurance Time During Constant Work Rate Cycle Ergometry Test in COPD

Inclusion criteria

• All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions.
• 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, at visit 1:

a post-bronchodilator 30% x2 ULN, SGPT > x2 ULN, bilirubin > x2 ULN or creatinine > x2 ULN will be excluded regardless of clinical condition

• Patients with a history of asthma
• A diagnosis of thyrotoxicosis
• A diagnosis of paroxysmal tachycardia (>100 beats per minute)
• A history of myocardial infarction within 1 year of screening visit (Visit 1)
• Unstable or life-threatening cardiac arrhythmia
• Hospitalized for heart failure within the past year
• Known active tuberculosis
• A malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years
• A history of life-threatening pulmonary obstruction and patients with chronic respiratory failure
• A history of cystic fibrosis
• Clinically evident bronchiectasis
• A history of significant alcohol or drug abuse
• Any contraindications for exercise testing
• Patients who have undergone thoracotomy with pulmonary resection
• Patients being treated with any oral ß-adrenergics
• Patients being treated with oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day
• 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
• Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the screening visit (Visit 1) or patients who are currently in a pulmonary rehabilitation program
• Patients who have a limitation of exercise performance as a result of factors other than fatigue or exertional dyspnoea or morbid obesity
• Patients with an endurance time >=25 minutes during the training (Visit 2) or baseline (Visit 3) constant work rate cycle ergometry
• Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to screening visit (Visit 1)
• Patients with known hypersensitivity to ß-adrenergic drugs, anticholinergic drugs, BAC, EDTA or any other component of the RESPIMAT inhalation solution delivery system
• Pregnant or nursing women
• Women of childbearing potential not using a highly effective method of birth control.

Female patients will be considered to be of childbearing potential unless surgically sterilised by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years

• Patients 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

At sites performing the shuttle walk tests, patients with the following criteria will be excluded from the shuttle walk tests:

• Patients who complete level 12 at the incremental shuttle walk test at visit 1a.
• Patients with an endurance time >=15 minutes during the training (Visit 2a) or baseline (visit 3a) endurance shuttle walk test.