Effect on Exercise Endurance and Lung Hyperinflation of Tiotropium + Olodaterol in COPD Patients
Pulmonary Disease, Chronic Obstructive
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive
Eligibility Criteria
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 a post-bronchodilator FEV1 <80% of predicted normal and a post-bronchodilator FEV1/FVC <70% at Visit 1.
- Male or female patients, between 40 and 75 years of age (inclusive) on day of signing informed consent.
- Patients must be current or ex-smokers with a smoking history of more than 10 pack years.
Exclusion criteria:
- Patients with a significant disease other than COPD; a significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the study, (ii) influence the results of the study, or (iii) cause concern regarding the patient's ability to participate in the study
- Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with an SGOT >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. 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:
- A diagnosis of thyrotoxicosis (due to the known class side effect profile of ß2-agonists)
- A diagnosis of paroxysmal tachycardia (>100 beats per minute) (due to the known class side effect profile of ß2-agonists)
- 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 (patients with treated basal cell carcinoma are allowed)
- A history of life-threatening pulmonary obstruction
- 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 with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion No. 1)
- Patients being treated with any oral ß-adrenergics
- Patients being treated with oral corticosteroid medication at unstable doses
- 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 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, such as arthritis in the leg, angina pectoris or claudication or morbid obesity.
- Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to screening visit
- Patients with known hypersensitivity to ß-adrenergics 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 highly effective methods of birth control.
Sites / Locations
- 1237.13.01302 Boehringer Ingelheim Investigational Site
- 1237.13.01308 Boehringer Ingelheim Investigational Site
- 1237.13.01304 Boehringer Ingelheim Investigational Site
- 1237.13.01307 Boehringer Ingelheim Investigational Site
- 1237.13.01305 Boehringer Ingelheim Investigational Site
- 1237.13.01301 Boehringer Ingelheim Investigational Site
- 1237.13.01303 Boehringer Ingelheim Investigational Site
- 1237.13.01306 Boehringer Ingelheim Investigational Site
- 1237.13.54301 Boehringer Ingelheim Investigational Site
- 1237.13.54302 Boehringer Ingelheim Investigational Site
- 1237.13.61306 Boehringer Ingelheim Investigational Site
- 1237.13.61301 Boehringer Ingelheim Investigational Site
- 1237.13.61305 Boehringer Ingelheim Investigational Site
- 1237.13.61304 Boehringer Ingelheim Investigational Site
- 1237.13.61302 Boehringer Ingelheim Investigational Site
- 1237.13.43303 Boehringer Ingelheim Investigational Site
- 1237.13.43301 Boehringer Ingelheim Investigational Site
- 1237.13.32302 Boehringer Ingelheim Investigational Site
- 1237.13.32303 Boehringer Ingelheim Investigational Site
- 1237.13.32305 Boehringer Ingelheim Investigational Site
- 1237.13.32304 Boehringer Ingelheim Investigational Site
- 1237.13.32301 Boehringer Ingelheim Investigational Site
- 1237.13.11302 Boehringer Ingelheim Investigational Site
- 1237.13.11303 Boehringer Ingelheim Investigational Site
- 1237.13.11304 Boehringer Ingelheim Investigational Site
- 1237.13.56301 Boehringer Ingelheim Investigational Site
- 1237.13.56302 Boehringer Ingelheim Investigational Site
- 1237.13.49302 Boehringer Ingelheim Investigational Site
- 1237.13.49307 Boehringer Ingelheim Investigational Site
- 1237.13.49304 Boehringer Ingelheim Investigational Site
- 1237.13.49301 Boehringer Ingelheim Investigational Site
- 1237.13.49303 Boehringer Ingelheim Investigational Site
- 1237.13.49305 Boehringer Ingelheim Investigational Site
- 1237.13.39302 Boehringer Ingelheim Investigational Site
- 1237.13.39304 Boehringer Ingelheim Investigational Site
- 1237.13.39303 Boehringer Ingelheim Investigational Site
- 1237.13.39305 Boehringer Ingelheim Investigational Site
- 1237.13.39301 Boehringer Ingelheim Investigational Site
- 1237.13.39312 Boehringer Ingelheim Investigational Site
- 1237.13.39310 Boehringer Ingelheim Investigational Site
- 1237.13.39308 Boehringer Ingelheim Investigational Site
- 1237.13.39306 Boehringer Ingelheim Investigational Site
- 1237.13.64302 Boehringer Ingelheim Investigational Site
- 1237.13.64301 Boehringer Ingelheim Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Active Comparator
Active Comparator
Placebo Comparator
Tiotropium + olodaterol High dose QD
Tiotropium + olodaterol Low dose QD
Tiotropium 5 mcg QD
Olodaterol 5 mcg QD
Placebo QD
patient will receive tiotropium 5 mcg + olodaterol 5 mcg in a fixed dose combination once daily
patient will receive tiotropium 2.5 mcg + olodaterol 5 mcg in a fixed dose combination once daily
patient will receive tiotropium 5 mcg once daily
patient will receive olodaterol 5 mcg once daily