Airway Hyper-responsiveness Study In Asthma Using Salmeterol/Fluticasone Propionate Combination Product

GlaxoSmithKline150 enrolled

Overview

This double-blind, stratified, parallel group study is to determine whether aiming for 'Total control' results in better airway hyper-responsiveness than maintaining the treatment level at which 'Well-controlled' asthma was achieved. The primary endpoint is the mean change in PC20 methacholine. Well controlled subjects (as assessed after a 12 week run-in period) will enter a 24 week treatment period during which they will record PEF(Peak Expiratory Flow), symptoms, rescue beta2-agonist use over 24 hours, night time awakenings, asthma exacerbations, emergency visits due to asthma and Adverse Events. At every visit lung function measurements and airway hyper-responsiveness will be measured.

A multi-centre, randomised, double blind, stratified, and parallel group study to evaluate whether a treatment strategy based on aiming for 'Total control' results in better airway hyper-responsiveness than a treatment strategy based on maintaining the treatment level at which 'Well-controlled' asthma was achieved.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

150

Conditions

Asthma

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria: * History of asthma of at least 6 months. * Subjects who have received fluticasone propionate at a dose of 100 mcg bd to 250 mcg bd or equivalent with or without a long acting beta2-agonist for at least 4 weeks before the start of the run-in period, at a constant dose. * Subjects who are able to understand and complete an electronic diary card. Exclusion criteria: * Subjects who have been hospitalized for their asthma within 4 weeks of study entry. * Subjects who had an acute upper respiratory tract infection within 4 weeks or a lower respiratory tract infection within 4 weeks prior to study entry. * Subjects who received oral, parental or depot corticosteroids within 4 weeks prior to study entry. * Subjects who have a known respiratory disorder other than asthma and/or systemic/thoracic abnormalities which influence normal lung function. * Subjects who have more than 5 pack years. * Subjects who currently smoke.

Locations (35)

GSK Investigational Site

Ghent, Belgium

GSK Investigational Site

Liège, Belgium

GSK Investigational Site

Tartu, Estonia

GSK Investigational Site

Jyväskylä, Finland

GSK Investigational Site

Tampere, Finland

GSK Investigational Site

Outcomes

Primary Outcomes

Mean change in PC20 methacholine (as a measure of airway hyper-responsiveness) following 24 weeks of treatment.

Secondary Outcomes

Number of 'Totally-controlled' and Well-controlled patients at the end of the run-in and treatment period according to the GOAL criteria.