Randomised, double-blind, placebo-controlled, 3-way cross-over study to determine the effect of 6 weeks treatment of orally inhaled BI 1744 CL (5 µg [2 actuations of 2.5 µg] and 10 µg [2 actuations of 5 µg]) delivered by the Respimat® Inhaler on exercise endurance time during constant work rate cycle ergometry in patients with Chronic Obstructive Pulmonary Disease (COPD)

Boehringer Ingelheim Pharma GmbH & Co. KG0 sites150 target enrollmentNovember 19, 2009

Overview

No summary available.

Registry

who.int

Start Date

November 19, 2009

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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 FEV1 \<80% of predicted normal (ECSC, Quanjer et al, Eur Respir J, 1993\) and a post\-bronchodilator FEV1/FVC \<70% at Visit 1 (ECSC predicted normal equations)
•3\. Male or female patients, between 40 and 75 years of age
•4\. Patients must be current or ex\-smokers with a smoking history of more than 10 pack years:
•Pack Years \= Number of cigarettes/day
•20 cigarettes/packx years of smoking
•Patients who have never smoked cigarettes must be excluded
•5\. Patients must be able to perform technically acceptable pulmonary function tests (body plethysmography, spirometry), must be able to complete multiple symptom\-limited cycle ergometry tests, 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 and from a metered dose inhaler (MDI)

•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 SGOT \>x2 ULN, 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 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)
•5\. Patients with any of the following conditions:
•\-a history of myocardial infarction within 1 year of screening visit (Visit 1\)
•\-unstable or life\-threatening cardiac arrhythmia.