Rationale for therapy with low dose steroids combined with long-acting beta2-agonists in patients with allergic asthma: redirecting innate immune responses by long-term treatment with high doses of inhaled steroids

GlaxoSmithKline0 sitesAugust 30, 2007

Overview

No summary available.

Registry

who.int

Start Date

August 30, 2007

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Inclusion criteria for entry into the run\-in period:
•1\. Male or female subjects \=18 years \= 50 years
•2\. Allergic asthma: positive skin prick test for at least one aeroallergen or RAST
•3\. Documented history of asthma according to GINA guidelines for a period of at least 6 months
•3\. Subjects who have received regular treatment with FP at a dose of 250 mcg bd or equivalent with or without a LABA for at least 4 weeks before start of the run\-in period, at a constant dose
•4\. Subjects with history of recurrent episodes of wheezing, breathlessness, chest tigthness and/or coughing in the previous year
•5\. Subjects who are able to use a DISKUS inhaler
•6\. Subjects who are able to perform reproducible lung function tests at Visit 1 (variation FEV1 smaller than 5% between the two best measurements)
•Inclusion criteria for entry into the treatment period:
•1\. Subjects with an FEV1% of predicted bigger than 70%

•Exclusion criteria for entry into the run\-in period:
•1\. Subjects who have been hospitalised for their asthma within 4 weeks of visit 1
•2\. Subjects who had an acute upper respiratory tract infection within 4 weeks or a lower respiratory tract infection within 4 weeks prior to visit 1
•3\. Subjects who received oral, parental, or depot corticosteroids within 4 weeks prior to visit 1
•4\. Subjects who have a known respiratory disorder other than asthma and/or systemic/thoracic abnormalities which influence normal lung function
•5\. Subjects who hae received any investigational drugs within 4 weeks of visit 1
•6\. Subjects with a known or suspected hypersensitivity to inhaled steroids, beta2\-agonists or lactose
•7\. Subjects who use any medication that significantly inhibits the cytochrome P450 subfamily enzyme CYP3A4, including ritonavir, ketoconazole, itraconazole and erythromycin
•8\. Subjects who concurrently participate in another clinical study
•9\. Subjects who have previously been randomised in this study