A randomised, double-blind, crossover study to investigate the bronchodilatation post-inhalation of GSK961081 alone and with the addition of cumulative doses of short acting bronchodilators (salbutamol and ipratropium bromide) in patients with COPD

GlaxoSmithKline Reaseach & Development0 sites45 target enrollmentFebruary 22, 2008

Overview

No summary available.

Registry

who.int

Start Date

February 22, 2008

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

GlaxoSmithKline Reaseach & Development

•A subject will be eligible for inclusion in this study only if all of the following criteria apply:
•1\. Subject is male or female (of non\-child bearing potential) \= 40 years of age and \= 75 years of age.
•Non\- child bearing potential is defined as physiologically incapable of becoming pregnant, including females who are post\-menopausal (more than 2 years without
•menses with appropriate clinical history i.e. age, history of vasomotor symptomsestradiol and FSH levels may be checked if indicated) and females who are
•surgically sterile (hysterectomy, tubal ligation or bilateral oophorectomy).
•2\. Subject diagnosed with COPD in accordance with ATS/ERS guidelines.
•3\. Subject is a smoker or an ex\-smoker with a history of at least 10 pack years (1 pack year \= 20 cigarettes smoked per day for 1 year or equivalent)
•4\. Subject has FEV1/FVC \< 0\.7 post\-bronchodilator (salbutamol)
•5\. Subject has FEV1 \< 80 % of predicted normal for height, age, gender after inhalation of salbutamol
•6\. Response to ipatropium bromide defined as:

•A subject will not be eligible for inclusion in this study if any of the following criteria
•1\. Subjects who have a past or present disease, which as judged by the Investigator and medical monitor may affect the outcome of the study or the safety of the subject
•2\. Subjects with clinically relevant findings on laboratory safety tests.
•3\. Women who are pregnant or lactating
•4\. An unwillingness of subjects to abstain from sexual intercourse with pregnant or
•lactating women; or an unwillingness of the subject to use a condom/spermicide in
•addition to having their female partner use another form of contraception such as
•IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone,
•subdermal implants or tubal ligation if the woman could become pregnant from the
•time of the first dose study medication until 90 days post\-dose