Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of 48 Weeks of Once Daily Treatment of Orally Inhaled BI 1744 CL (5µg [2actuations of 2.5 µg] and 10 µg [2 actuations of 5 µg]) Delivered by the Respimat® Inhaler, in patients with Chronic Obstructive Pulmonary Disease (COPD).
- Conditions
- Chronic Obstructive Pulmonary DiseaseMedDRA version: 9.1Level: LLTClassification code 10010952Term: COPD
- Registration Number
- EUCTR2008-003704-67-DE
- Lead Sponsor
- Boehringer Ingelheim Pharma GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 882
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 (P06-12085) and must meet the following spirometric criteria:
Patients must have relatively stable airway obstruction with a post-bronchodilator <80% of predicted normal (ECCS, R94-1408) and a post-bronchodilator FEV1 / FVC <70% at Visit 1
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 (both supervised) and PEFR measurements, and must be able to maintain records (Patient Daily e-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 and from a metered dose inhaler (MDI).
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 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
2.Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with an AST (SGOT) >x2 ULN, ALT (SGPT) >x2 ULN, bilirubin >x2 ULN or creatinine >x2 ULN will be excluded regardless of clinical condition (a repeat laboratory evaluation will not be conducted in these patients)
3.Patients with a history of asthma. For patients with allergic rhinitis or atopy, source documentation is required to verify that the patient does not have asthma. If a patient has a total blood eosinophil count greater than or euqal to 600/mm3, source documentation is required to verify that the increased eosinophil count is related to a non-asthmatic condition.
4.Patients with any of the following conditions:
–a diagnosis of thyrotoxicosis (due to the known class side effect profile of
ß2-agonists)
–a diagnosis of paroxysmal tachycardia (>100 beats per minute [due to the known class side effect profile of ß2-agonists])
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 assess the long-term efficacy and safety of once daily treatment of orally inhaled BI 1744 CL (5 mcg and 10 mcg) delivered by the Respimat inhaler, compared with placebo, in patients with COPD.;Secondary Objective: ;Primary end point(s): The primary criterion for evaluation is measurement of FEV1 obtained during pulmonary function testing (PFT). The qualifying pulmonary function tests (FEV1 and FVC) will be conducted at the Screening Visit (Visit 1).
- Secondary Outcome Measures
Name Time Method