Airway Hyper-responsiveness Study In Asthma Using Salmeterol/Fluticasone Propionate Combination Product
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
1 other identifier
interventional
150
9 countries
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 asthma
Started Nov 2005
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 13, 2006
CompletedFirst Posted
Study publicly available on registry
February 14, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedMay 30, 2017
May 1, 2017
1.7 years
February 13, 2006
May 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean change in PC20 methacholine (as a measure of airway hyper-responsiveness) following 24 weeks of treatment.
Secondary Outcomes (1)
Number of 'Totally-controlled' and Well-controlled patients at the end of the run-in and treatment period according to the GOAL criteria.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (35)
GSK Investigational Site
Ghent, 9000, Belgium
GSK Investigational Site
Liège, 4000, Belgium
GSK Investigational Site
Tartu, 51014, Estonia
GSK Investigational Site
Jyväskylä, 40100, Finland
GSK Investigational Site
Tampere, 33100, Finland
GSK Investigational Site
Lille, 59042, France
GSK Investigational Site
Montpellier, 34295, France
GSK Investigational Site
Poitiers, 86000 cedex, France
GSK Investigational Site
Sinsheim, Baden-Wurttemberg, 74889, Germany
GSK Investigational Site
Bonn, North Rhine-Westphalia, 53123, Germany
GSK Investigational Site
Berlin, 10559, Germany
GSK Investigational Site
Berlin, 13353, Germany
GSK Investigational Site
Berlin, 13359, Germany
GSK Investigational Site
Foggia, Apulia, 71100, Italy
GSK Investigational Site
Cagliari, Sardinia, 09126, Italy
GSK Investigational Site
Torrette (AN), The Marches, 60020, Italy
GSK Investigational Site
Pisa, Tuscany, 56124, Italy
GSK Investigational Site
Bussolengo (VR), Veneto, 37012, Italy
GSK Investigational Site
Salerno, 84100, Italy
GSK Investigational Site
Riga, LV 1003, Latvia
GSK Investigational Site
Riga, LV 1035, Latvia
GSK Investigational Site
Breda, 4819 EV, Netherlands
GSK Investigational Site
Groningen, 9721 SW, Netherlands
GSK Investigational Site
Harderwijk, 3844 DG, Netherlands
GSK Investigational Site
Helmond, 5707 HA, Netherlands
GSK Investigational Site
Hoorn, 1624 NP, Netherlands
GSK Investigational Site
Nieuwegein, 3435 CM, Netherlands
GSK Investigational Site
Veldhoven, 5504 DB, Netherlands
GSK Investigational Site
Barcelona, 08022, Spain
GSK Investigational Site
Madrid, 28006, Spain
GSK Investigational Site
Tarrasa, Barcelona, 08221, Spain
GSK Investigational Site
Valencia, 46017, Spain
GSK Investigational Site
Gothenburg, SE-413 45, Sweden
GSK Investigational Site
Linköping, SE-585 81, Sweden
GSK Investigational Site
Lund, SE-221 85, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials, MD
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2006
First Posted
February 14, 2006
Study Start
November 1, 2005
Primary Completion
July 1, 2007
Study Completion
July 1, 2007
Last Updated
May 30, 2017
Record last verified: 2017-05