COPD (Chronic Obstructive Pulmonary Disease
Conditions
Interventions
Patients will recieve twice:
_ Bronchodilator therapy
during 6 weeks a once daily inhalation of
studymedication with the Respimat® Inhaler with one
of the following treatments:
1. tiotropium + olodaterol (5 ~g/5 ~g) fixed dose combination inhalation
so
COPD trials
Shuttle test
Tiotropium/ olodaterol
Sponsors
Boehringer Ingelheim
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - All patients must sign an informed consent consistent with International Conference on Harmonization - Good Clinical Practice (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 30% <
Exclusion criteria
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 a, in the opinion of the investigator, clinically relevant abnormal baseline haematology, blood chemistry, or creatinine >x2 ULN will be excluded regardless of clinical condition.;- Patients with a current documented diagnosis of asthma. For patients with allergic rhinitis or atopy, source documentation is required to verify that the patient does not have asthma.;- Patients with a COPD exacerbation in the 6 weeks prior to screening (visit 1).;- A diagnosis of thyrotoxicosis (due to the known class side effect profile of B2-agonists);- A history of myocardial infarction within 6 months of screening visit (visit 1);- Life-threatening cardiac arrhythmia as judged by the Investigator.;- Known active tuberculosis;- Any malignancy unless free of disease for at least 5 years (patients with treated basal cell carcinoma or squamous cell skin cancers are allowed);- A history of cystic fibrosis;- Clinically relevant bronchiectasis, as judged by the Investigator.;- Patients with severe emphysema requiring endobronchial interventions within 6 months prior to screening.;- A history of significant alcohol or drug abuse, as judged by the investigator.;- Any contraindications for exercise testing as outlined below.;- 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 or patch ß-adrenergics;- Patients being treated with oral corticosteroid medication at unstable doses (i.e., less than four 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 being treated with antibiotics for any reason (not limited to exacerbation infection) within 4 weeks of screening visit.;- Patients being treated with PDE4 inhibitors within 3 months of screening visit (e.g.roflumilast) should not be enrolled and PDE4 inhibitors should not be withdrawn for the purpose of enrolling in this study.;- 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 dyspnea, such as arthritis in the leg, angina pectoris or claudication or morbid obesity.;- Patients with an endurance time >=12 minutes during the incremental shuttle walk test (visit1).;- Patients with oxygen saturation < 85% (on room air) at rest or during exercise.;- Patients who have taken an investigational drug within one month or six half-lives (whichever is greater) or in case the investigational drug (sub) class is listed within the washout period specified prior to screening visit (visit 1);- Patients with known hypersensitivity to ß-adrenergics and/or anticholinergic drugs, BAC, EDTA or any ot
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the study is to evaluate the effect of tiotropium + olodaterol FDC compared to tiotropium monotherapy on the intensity of breathlessness during the 3min CSST. | — |
Secondary
| Measure | Time frame |
|---|---|
| A secondary objective is to explore the relationship between reductions in breathlessness during the 3min CSST and reductions in breathlessness during activities of everyday living as measured by the dyspnea domain of the Chronic Respiratory Questionnaire (CRQ) following bronchodilator therapy Secondary Endpoints include: Change from baseline in Inspiratory Capacity (IC) measured prior to exercise, after 6 weeks of treatment. Change from baseline in IC measured at the end of exercise, after 6 weeks of treatment Change from baseline in 1 hour post-dose FEV1, after 6 weeks of treatment. Change from baseline in 1 hour post-dose FVC, after 6 weeks of treatment. Change from baseline in intensity of Breathlessness (MBS-S) at 1, 2 and 2.5 min during the 3min CSST after 6 weeks of treatment. Change in CRQ-SAI dyspnea subscale score after 6 weeks of treatment. Change in CRQ-SAS dyspnea subscale score after 6 weeks of treatment. None of the primary or secondary endpoints are safety issues. | — |
Countries
Belgium, Canada, Germany, Netherlands
Outcome results
None listed