A Randomized, Multiple-dose, Double-Blind, Placebo- and Active-Controlled, Parallel Group Efficacy and Safety Study to determine the Optimum Dose of BEA 2180 BR Delivered by the Respimat Inhaler in Patients with Chronic Obstructive PulmonaryDisease (COPD) -
- Conditions
- Chronic Obstructive Pulmonary Disease
- Registration Number
- EUCTR2005-000650-79-BE
- Lead Sponsor
- Boehringer Ingelheim Coordination Centre Belgium
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 420
1. All patients must have a diagnosis of chronic obstructive pulmonary and must meet the following spirometric criteria:
Patients must have relatively stable, moderate to severe airway obstruction with an FEV1 =30% and = 60% of predicted normal and FEV1 =70% of FVC at the baseline PFTs at Visit 1.
2. All patients must have an increase in FEV1 of at least 12% from baseline 45 min after inhalation of 80 µg Atrovent HFA MDI.
3.All patients must have an increase in FEV1 of at least 12% from baseline (the -10 minute measurement) 45 min after inhalation of 80 µg Atrovent HFA MDI.
4.Male or female patients 40 years of age or older.
5.Patients must be current or ex-smokers with a smoking history of more than 10 pack years.
6.Patients must be able to perform technically acceptable pulmonary function tests and PEFR measurements, and must be able to maintain records (Patient Daily Diary Card) during the study period as required in the protocol.
7.Patients must be able to inhale medication in a competent manner from the Respimat® inhaler (Appendix 1) and from a metered dose inhaler (MDI).
8. The mean of the two baseline FEV1 values (-1 hour and -10 minutes) at Visit 2 must be within 15% of mean of the two baseline FEV1 values (-1 hour and -10 minutes) performed at Visit 1.
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 a history of asthma, allergic rhinitis or who have a total blood eosinophil count greater than or equal to 600/mm3. A repeat eosinophil count will not be conducted in these patients.
3.All patients with an AST (SGOT) >80 IU/L, ALT (SGPT) >80 IU/L, total bilirubin >2 mg/dL or creatinine >2.4 mg/dL will be excluded regardless of clinical condition. Repeat laboratory evaluation will not be conducted in these patients.
4.Patients with a recent history (one year or less) of myocardial infarction.
5.Patients with any unstable or life-threatening cardiac arrhythmia or patients who have been hospitalized for such an event within the past year.
6.Patients who have been hospitalized for heart failure within the past 3 years.
7.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.
8.Patients with known symptomatic prostatic hyperplasia or bladder neck obstruction as defined in exclusion criteria No. 1.
9.Patients with known narrow-angle glaucoma.
10.Patients with a history of asthma, allergic rhinitis or who have a total blood eosinophil count greater than or equal to 600/mm3. A repeat eosinophil count will not be conducted in these patients.
11.Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis.
12.Patients with known active tuberculosis.
13.Patients with a history of and/or active significant alcohol or drug abuse. See exclusion criterion No. 1.
14.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.
15. Patients who have completed a pulmonary rehabilitation program in the 6 weeks prior to the Screening Visit (Visit 1) or patients who are currently in a pulmonary rehabilitation program.
16.Patients who regularly use daytime oxygen therapy and in the investigator’s opinion will be unable to abstain from the use of oxygen therapy.
17.Patients who have taken an investigational drug within 1 month or six half lives (whichever is greater) prior to Screening Visit (Visit 1).
18.Patients who are being treated with beta-blocker medications. Note: cardioselective beta blocker eye medications (e.g. Betoptic®) for treatment of non-narrow angle glaucoma are allowed.
19.Patients who are being treated with oral beta-adrenergics.
20.Patients who are being treated with cromolyn sodium or nedocromil sodium.
21.Patients who are being treated with antihistamines (H1 receptor antagonists), anti leukotrienes or leukotriene receptor antagonists for asthma or excluded allergic conditions. See exclusion criterion Number 10.
22.Patients using oral corticosteroid medication at unstable doses (i.e., less than 6 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.
23.Patients with known hypersensitivity to anticholinergic drugs, BAC, EDTA or any other components of the Respimat® inhalation solution de
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 determine the optimum dose(s) of BEA 2180 BR inhalation solution delivered by the Respimat® inhaler once daily for four weeks in patients with chronic obstructive pulmonary disease (COPD). ;Secondary Objective: The secondary objective is to compare the safety and efficacy of BEA 2180 BR inhalation solution delivered by the inhaler to placebo and to tiotropium bromide inhalation solution delivered by the Respimat®.;Primary end point(s): The primary endpoint is trough FEV1 response determined at the end of the four-week treatment period. Trough FEV1 is defined as the mean of the two FEV1 values (performed at -1 hour and -10 minutes prior to test-drug inhalation) 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.
- Secondary Outcome Measures
Name Time Method