A multinational, randomised, double-blind, placebo. and active-controlled, parallel group efficacy and safety comparison over 24 weeks of three doses (50µg, 100µg, 200µg) of BEA 2180 to tiotropium 5 µg and placebo delivered by the Respimat(R) inhaler and placebo in patients with chronic obstructive pulmonary disease (COPD)
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)MedDRA version: 9.1Level: PTClassification code 10009033Term: Chronic obstructive pulmonary disease
- Registration Number
- EUCTR2007-001946-42-DE
- Lead Sponsor
- Boehringer Ingelheim Pharma GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1950
1.All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions.
2.All patients must have a diagnosis of chronic obstructive pulmonary disease (P95 4381) and must meet the following spirometric criteria:
Patients must have relatively stable, moderate to severe airway obstruction with an FEV1 (post-bronchodilator, 30 minutes post salbutamol/albuterol) <80% of predicted normal and FEV1 =70% of FVC at the PFTs at Visit 1 (screening).
3.Male or female patients 40 years of age or older.
4.Patients must be current or ex-smokers with a smoking history of more than 10 pack years. Patients who have never smoked cigarettes must be excluded.
5.Patients must be able to perform technically acceptable pulmonary function tests and electronic PEFR measurements, and must be able to maintain records (Patient Daily Diary) during the study period as required in the protocol.
6.Patients must be able to inhale medication in a competent manner from the Respimat® inhaler (Appendix I)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1.Patients with significant diseases other than COPD will be excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient’s ability to participate in the study.
2.Patients with clinically relevant abnormal baseline haematology, blood chemistry or urinalysis, if the abnormality defines a significant disease as defined in exclusion criterion No. 1.
3.Patients with a recent history (one year or less) of myocardial infarction.
4.Patients with any unstable or life-threatening cardiac arrhythmia or patients who have been hospitalized for such an event within the past year.
5.Patients who have been hospitalized for heart failure within the past 3 years.
6.Patients with a malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years. Patients with treated basal cell carcinoma are allowed.
7.Patients with known symptomatic prostatic hyperplasia or bladder neck obstruction as defined in exclusion criteria No. 1.
8.Patients with known narrow-angle glaucoma.
9.Patients with asthma or a history of asthma.
10.Patients who regularly use daytime oxygen therapy and in the investigator’s opinion will be unable to abstain from the use of oxygen therapy during the test day.
11.Patients who are being treated with non-cardioselective beta-blocker medications (e.g., propranolol) within 30 days prior to the screening visit (Visit 1).
12.Patients who have taken Spiriva® within 30 days prior to the screening visit (Visit 1).
13.Patients using oral corticosteroid medication at unstable doses (i.e., less than 6 weeks on a stable dose).
14.Patients with previous participation (receipt of randomized treatment) in this study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to compare the bronchodilator efficacy of three doses (50 mcg, 100 mcg and 200 mcg) of BEA 2180 delivered by the Respimat once daily to placebo and tiotropium bromide delivered by the Respimat in patients with COPD. ;Secondary Objective: Additional objectives include comparing the effects of BEA 2180 on dyspnea and health status. ;Primary end point(s): The primary endpoint in this study is trough FEV1 response after 24 weeks. <br>Trough FEV1 is defined as the mean of the two FEV1 measurements recorded at the pre-dose measurements (-40 and -15 minutes) at the end of the dosing interval 24 hours post drug administration from the Respimat® Inhaler. Trough FEV1 response is defined as the change from baseline in trough FEV1. Baseline FEV1 is pre treatment FEV1 values measured at Visit 2 (test-day 1) prior to administration of the first dose of study medication. The baseline value will be the mean of the -40 and -15 minute PFTs on Visit 2. <br>
- Secondary Outcome Measures
Name Time Method