Pharmacokinetics and dose-ranging of tiotropium inhalation solution delivered from the Respimat inhaler in patients with Chronic Obstructive Pulmonary Disease (COPD)

SCS Boehringer Ingelheim Comm.V0 sites160 target enrollmentAugust 16, 2010

Overview

No summary available.

Registry

who.int

Start Date

August 16, 2010

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

SCS Boehringer Ingelheim Comm.V

•1\. All patients must sign an informed consent consistent with ICH\-GCP guidelines
•and local legislations prior to any study\-related procedures, which includes
•medication washout and restrictions.
•2\. Male or female patients 40 years of age or older.
•3\. Patients must be current or ex\-smokers with a smoking history of \= 10 pack\-
•years (patients who have never smoked cigarettes must be excluded).
•4\. All patients must have a diagnosis of COPD and must meet the following criteria:
•Relatively stable airway obstruction with a post\-bronchodilator FEV1 \< 80% of
•predicted normal and post\-bronchodilator FEV1 \< 70% of post\-bronchodilator
•5\. Patients must be able to perform technically acceptable pulmonary function tests

•1\. Significant diseases other than COPD.
•2\. Patients with a recent history (i.e., six months or less) of myocardial infarction.
•3\. Patients with any unstable or life\-threatening cardiac arrhythmia requiring
•intervention or change in drug therapy during the past year.
•4\. Hospitalisation for cardiac failure during the past year.
•5\. 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.
•6\. Patients with a history of asthma or who have a total blood eosinophil count
•greater than 600/mm3\.