chronic obstructive pulmonary disease COPD
Conditions
Interventions
Bronchodilator therapy
during twelve 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 inhalat
Sponsors
Boehringer Ingelheim
Eligibility
Age
18 Years to 99 Years
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 30%
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 |
|---|---|
| The primary endpoint is endurance time [sec] during ESWT to symptom limitation at walking speed corresponding to 85% of predicted maximum oxygen consumption (VO2 peak) after 8 weeks of pharmacological treatment and non-pharmacological intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Average daily walking time measured by the activity monitor in the week prior to Week 12. - Average daily walking intensity measured by the activity monitor in the week prior to Week 12. - Perceived difficulties as evaluated with FPI-SF total score at Week 12. - Endurance time during ESWT to symptom limitation at walking speed corresponding to 85% of predicted maximum oxygen consumption (VO2 peak) after 12 weeks of treatment. - 1 hour post-dose FEV1, after 8 weeks of treatment. - 1 hour post-dose FVC, after 8 weeks of treatment. - Resting IC measured at 1.5 hours post *dose, after 8 weeks of treatment. | — |
Countries
Netherlands
Outcome results
None listed