Clinical trial NCT00291382: Airway Hyper-responsiveness Study In Asthma Using Salmeterol/Fluticasone Propionate Combination Product
Official title: A Multicentre, Stratified, Randomised, Double Blind, Parallel Group Trial to Evaluate Whether a Treatment Strategy Based on Aiming for Total Control Results in Better AHR Than a Treatment Strategy Based on Maintaining Well Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: Total asthma control
airway hyper-responsiveness
adult
Asthma
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-02-14
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean change in PC20 methacholine (as a measure of airway hyper-responsiveness) following 24 weeks of treatment.
Secondary outcomes:
measure: Number of 'Totally-controlled' and Well-controlled patients at the end of the run-in and treatment period according to the GOAL criteria.
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: GSK Investigational Site
city: Liège
country: Belgium
facility: GSK Investigational Site
city: Tartu
country: Estonia
facility: GSK Investigational Site
city: Jyvaskyla
country: Finland
facility: GSK Investigational Site
city: Tampere
country: Finland
facility: GSK Investigational Site
city: Lille cedex
country: France
facility: GSK Investigational Site
city: Montpellier
country: France
facility: GSK Investigational Site
city: Poitiers
country: France
facility: GSK Investigational Site
city: Sinsheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Bonn
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Torrette (AN)
country: Italy
facility: GSK Investigational Site
state: Marche
city: Foggia
country: Italy
facility: GSK Investigational Site
state: Puglia
city: Cagliari
country: Italy
facility: GSK Investigational Site
state: Sardegna
city: Pisa
country: Italy
facility: GSK Investigational Site
state: Toscana
city: Bussolengo (VR)
country: Italy
facility: GSK Investigational Site
state: Veneto
city: Salerno
country: Italy
facility: GSK Investigational Site
city: Riga
country: Latvia
facility: GSK Investigational Site
city: Riga
country: Latvia
facility: GSK Investigational Site
city: Breda
country: Netherlands
facility: GSK Investigational Site
city: Groningen
country: Netherlands
facility: GSK Investigational Site
city: Harderwijk
country: Netherlands
facility: GSK Investigational Site
city: Helmond
country: Netherlands
facility: GSK Investigational Site
city: Hoorn
country: Netherlands
facility: GSK Investigational Site
city: Nieuwegein
country: Netherlands
facility: GSK Investigational Site
city: Veldhoven
country: Netherlands
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Tarrasa, Barcelona
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Göteborg
country: Sweden
facility: GSK Investigational Site
city: Linköping
country: Sweden
facility: GSK Investigational Site
city: Lund
country: Sweden
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_DIRECTOR
References: