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Tracking Information | |||||
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First Received Date † | February 13, 2006 | ||||
Last Updated Date | November 13, 2008 | ||||
Start Date † | November 2005 | ||||
Current Primary Outcome Measures † |
Mean change in PC20 methacholine (as a measure of airway hyper-responsiveness) following 24 weeks of treatment. | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00291382 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
Number of 'Totally-controlled' and Well-controlled patients at the end of the run-in and treatment period according to the GOAL criteria. | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Airway Hyper-Responsiveness Study In Asthma Using Salmeterol/Fluticasone Propionate Combination Product | ||||
Official Title † | See Detailed Description | ||||
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. |
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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. |
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Study Phase | Phase IV | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study | ||||
Condition † | Asthma | ||||
Intervention † | Drug: Salmeterol/fluticasone propionate combination | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 150 | ||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion criteria:
Exclusion criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | Belgium, Estonia, Finland, France, Germany, Italy, Latvia, Netherlands, Spain, Sweden | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00291382 | ||||
Responsible Party | Study Director, GSK | ||||
Secondary IDs †† | |||||
Study Sponsor † | GlaxoSmithKline | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | GlaxoSmithKline | ||||
Verification Date | November 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |