Chronic Obstructive Pulmonary Disease (COPD) MedDRA version: 17.0 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855
Conditions
Interventions
Product Name: Tiotropium 2.5µg/Olodaterol 2.5µg
Pharmaceutical Form: Inhalation vapour, solution
INN or Proposed INN: TIOTROPIUM
CAS Number: 186691-13-4
Other descriptive name: TIOTROPIUM
Concentratio
Sponsors
Boehringer Ingelheim Limited
Eligibility
Sex/Gender
All
Inclusion 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 ( = forced expiratory volume in one second) =30% and =65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: - Patients with a significant disease other than chronic obstructive pulmonary disease. - Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis. - 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. - 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 investigators 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, benzalkonium chloride, disodium edentat, 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. - Patients who have previously been randomized in this study or are currently participating in another study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore the effect of treatment with orally inhaled tiotropium and olodaterol in fixed dose combination with and without exercise training, and tiotropium comparing to placebo, on top of behavioural modification in improving exercise capacity in patients with COPD;Secondary Objective: To evaluate the effect of interventions (pharmacological intervention +/- exercise training, with a comprehensive behavioral modification program) on two domains of physical activity (i) amount of physical activity (as measured with the activity monitor) (ii) perceived difficulties associated with physical activity (as measured by the FPI questionnaire);Primary end point(s): 1: Endurance time [sec] during Endurance Shuttle Walk Test to symptom limitation at walking speed corresponding to 85% of predicted maximum oxygen consumption after 8 weeks of treatment ;Timepoint(s) of evaluation of this end point: 1: 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1: Average daily walking time measured by the activity monitor in the week prior to 12 weeks of treatment 2: Average daily walking intensity measured by the activity monitor in the week prior to 12 weeks of treatment 3: Functional Performance Inventory-Short Form score at Week 12 4: Endurance time [sec] during Endurance Shuttle Walk Test to symptom limitation at walking speed corresponding to 85% of predicted maximum oxygen consumption after 12 weeks of treatment 5: One hour post-dose forced expiratory volume in one second after 8 weeks of treatment 6: One hour post-dose forced vital capacity after 8 weeks of treatment 7: Resting inspiratory capacity measured at 1.5 hours post dose after 8 weeks of treatment ;Timepoint(s) of evaluation of this end point: 1: 12 weeks 2: 12 weeks 3: 12 weeks 4: 12 weeks 5: 8 weeks 6: 8 weeks 7: 8 weeks 6: 8 weeks 7: 8 weeks | — |
Countries
Australia, Austria, Belgium, Canada, Denmark, Germany, New Zealand, Poland, Portugal, United Kingdom, United States
Contacts
Public ContactQRPE PSC CT Information Disclosure
Boehringer Ingelheim GmbH & Co. KG
Outcome results
None listed