A randomised, double-blind, placebo-controlled, parallel group, dose ranging study evaluating the efficacy and safety of GW642444M administered once daily compared with placebo for 28 days in adolescent and adult subjects with persistent asthma.

GlaxoSmithKline Research & Development0 sites600 target enrollmentDecember 3, 2007

Overview

No summary available.

Registry

who.int

Start Date

December 3, 2007

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Subjects eligible for enrolment in the study must meet all of the following criteria:
•1 Aged 12 years of age or older at Visit 1
•For sites in the following countries, subjects recruited will be \= 18 years of age:
•Germany, Hungary and the Russian Federation and any other countries where local
•regulations or the regulatory status of study medication permit enrolment of adults
•2 Male or eligible female subjects
•A female is eligible to enter and participate in the study if she is of: Non\-child bearing potential (i.e. physiologically incapable of becoming pregnant), including any female who is post\-menopausal. Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly (i.e. in accordance with the approved product label and the instructions of the physician for the duration of the study – screening to follow\-up contact):
•Complete abstinence from intercourse from screening until 2 weeks after the
•follow\-up contact; or
•Sterilisation of male partner (vasectomy with documentation of azoospermia)

•1 Culture\-documented or suspected bacterial or viral infection of the upper or lower
•respiratory tract, sinus or middle ear and/or exacerbation of asthma within 4 weeks
•of Visit 1\.
•2 History of life\-threatening asthma, defined as an asthma episode that required
•intubation and/or was associated with hypercapnoea, respiratory arrest or hypoxia
•3 Asthma exacerbation requiring treatment with oral corticosteroids within 3 months
•prior to Visit 1\.
•4 Hospitalised for an asthma exacerbation within 6 months of Visit 1\.
•Hospitalisation is defined as an overnight stay in a hospital.
•5 Previously enrolled in this study, or has participated in any study using an