A randomised, double-blind, active-controlled parallel group study to evaluate the effect of 52 weeks of once daily treatment of orally inhaled tiotropium + olodaterol fixed dose combination compared with tiotropium on Chronic Obstructive Pulmonary Disease (COPD) exacerbation in patients with severe to very severe COPD.
- Conditions
- chronic obstructive pulmonary diseaseCOPD10038716
- Registration Number
- NL-OMON44270
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 171
- 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:
* stable airway obstruction with a post-bronchodilator FEV1< 60% of predicted normal
* and a postbronchodilator FEV1/FVC <70% documented at Visit 1
- Patients with a documented history of at least one moderate to severe COPD exacerbation in the previous 12 months requiring treatment with systemic corticosteroids and/or antibiotics and/or related hospitalization.
- Investigator should also ascertain that the patient is symptomatically stable as defined by:
* no evidence of COPD exacerbation requiring use of either antibiotics and/or steroids 4
weeks prior to visit 1,
* no evidence of change in their usual COPD medication 4 weeks prior to visit 1.
- Male or female patients, 40 years of age or older.
- Patients must be current or ex-smokers with a smoking history of more than 10 pack years.
- Patients must be able to perform all trial related procedures at the investigator discretion
including:
* technically acceptable and eligible pulmonary function test (if performed at site)
* vital status follow-up in case of discontinuation until the predicted exit date (i.e.: 52 weeks from first intake of randomised treatment + 21 days).
* COPD exacerbation interview every 6 weeks in case of premature discontinuation until the predicted exit date (i.e.: 52 weeks from first intake of randomised treatment + 21 days).
- Patients must be able to inhale medication in a competent manner from the Respimat®
inhaler (Appendix 10.1), and from a metered dose inhaler (MDI) in the opinion of the
investigator.
- 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 corrent documented diagnosis of asthma.;Patients with one of the following conditions:
- A diagnosis of thyrotoxicosis (due to the known class side effect profile of ß2-agonists)
- A history of myocardial infarction within 6 months of screening visit.
- Life-threatening cardiac arrhythmia.
- Known active tuberculosis.
- A malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years.
- A history of cystic fibrosis.
- Clinically relevant bronchiectasis.
- Patients with severe emphysema requiring endobronchial interventions within 6 months
prior to screening
- A history of significant alcohol or drug abuse.
- 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 being treated with antibiotics for any reason 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 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.
- Patients who are unable to comply with pulmonary medication restrictions prior to randomization.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint:<br /><br>- Annualised rate of moderate to severe COPD exacerbation during the treatment<br /><br>period (within 1 day after the last drug administration date).</p><br>
- Secondary Outcome Measures
Name Time Method