Safety and Efficacy of GW685698X an Inhaled Corticosteroid Once Daily and Twice Daily for the Treatment of Asthma
NCT ID: NCT00766090
Last Updated: 2016-12-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
190 participants
INTERVENTIONAL
2008-10-31
2009-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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GW685698X
GW685698X
Inhaled Corticosteroid
Interventions
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GW685698X
Inhaled Corticosteroid
Eligibility Criteria
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Inclusion Criteria
* Reversibility ≥ 12% and ≥200mls reversibility of FEV1 within approximately 30-minutes following 2 to 4 puffs of albuterol
* FEV1 between 40-85% predicted
* Currently on short acting beta2 agonist therapy
Exclusion Criteria
* Respiratory Infection or oropharyngeal candidiasis
* Asthma exacerbation
* Uncontrolled disease or clinical abnormality
* Allergies
* Taking another Investigational medications or other prohibited medications
12 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Long Beach, California, United States
GSK Investigational Site
Long Beach, California, United States
GSK Investigational Site
Torrance, California, United States
GSK Investigational Site
Cocoa, Florida, United States
GSK Investigational Site
Tallahassee, Florida, United States
GSK Investigational Site
Bethesda, Maryland, United States
GSK Investigational Site
Columbia, Missouri, United States
GSK Investigational Site
Rolla, Missouri, United States
GSK Investigational Site
Raleigh, North Carolina, United States
GSK Investigational Site
Canton, Ohio, United States
GSK Investigational Site
Medford, Oregon, United States
GSK Investigational Site
Orangeburg, South Carolina, United States
GSK Investigational Site
Austin, Texas, United States
GSK Investigational Site
Boerne, Texas, United States
GSK Investigational Site
San Antonio, Texas, United States
GSK Investigational Site
Waco, Texas, United States
Countries
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References
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Woodcock A, Bleecker ER, Busse WW, Lotvall J, Snowise NG, Frith L, Jacques L, Haumann B, Bateman ED. Fluticasone furoate: once-daily evening treatment versus twice-daily treatment in moderate asthma. Respir Res. 2011 Dec 21;12(1):160. doi: 10.1186/1465-9921-12-160.
O'Byrne PM, Jacques L, Goldfrad C, Kwon N, Perrio M, Yates LJ, Busse WW. Integrated safety and efficacy analysis of once-daily fluticasone furoate for the treatment of asthma. Respir Res. 2016 Nov 24;17(1):157. doi: 10.1186/s12931-016-0473-x.
Study Documents
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Document Type: Annotated Case Report Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Dataset Specification
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Study Protocol
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Informed Consent Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Statistical Analysis Plan
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Clinical Study Report
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Individual Participant Data Set
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentRelated Links
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Other Identifiers
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112202
Identifier Type: -
Identifier Source: org_study_id
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