Pharmacokinetics and dose-ranging of tiotropium inhalation solution delivered from the Respimat inhaler in patients with Chronic Obstructive Pulmonary Disease (COPD) - Tiotropium Respimat PK study 205.458

Boehringer Ingelheim0 sites32 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sponsor

•1\. All patients must sign an informed consent consistent with ICH\-GCP guidelines and local legislations prior to any study\-related procedures, including 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 at least 10 pack\-years.
•4\. All patients must have a diagnosis of COPD (refer to page 22 of study protocol).
•5\. Patients must be able to perform technically acceptable pulmonary function tests.
•6\. Patients must be able to inhale medication in a competent manner from the Respimat and HandiHaler devices.

•1\. Significant diseases other than COPD (refer to page 23 of study protocol).
•2\. Patients with a recent history of myocardial infarction.
•3\. Patients with any unstable of 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\. Patients with a history of asthma or who have a total eosinophil count equal to or above 600/mm3\.
•6\. Use of systemic corticosteroid medication at unstable doses (less than 6 weeks on stable dose) or at doses in excess of the equivalent of 10 mg prednisone per day or 20 mg every other day.
•7\. Pregnant or nursing women.

Not specified