Study HZA106829: Efficacy/Safety Study of Fluticasone Furoate/Vilanterol (GW642444) in Adult and Adolescent Asthmatics
NCT ID: NCT01134042
Last Updated: 2017-01-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
587 participants
INTERVENTIONAL
2010-06-30
2011-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Fluticasone Furoate/Vilanterol
Fluticasone furoate/vilanterol inhalation powder once daily + Placebo inhalation powder twice daily for 24 weeks
Fluticasone Furoate/Vilanterol Inhalation Powder
Fluticasone furoate/Vilanterol inhalation powder inhaled orally once daily for 24 weeks
Placebo Inhalation Powder 2
Placebo in Diskus inhaler twice daily
Fluticasone Furoate
Fluticasone furoate inhalation powder once daily + Placebo inhalation powder twice daily for 24 weeks
Fluticasone Furoate Inhalation Powder
Fluticasone furoate inhalation powder inhaled orally once daily for 24 weeks
Placebo Inhalation Powder 2
Placebo in Diskus inhaler twice daily
Fluticasone Propionate
Fluticasone propionate inhalation powder twice daily + Placebo inhalation powder once daily for 24 weeks
Fluticasone Propionate Inhalation Powder
Fluticasone propionate inhalation powder inhaled orally twice daily for 24 weeks
Placebo Inhalation Powder 1
Placebo in novel dry powder inhaler once daily
Interventions
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Fluticasone Furoate/Vilanterol Inhalation Powder
Fluticasone furoate/Vilanterol inhalation powder inhaled orally once daily for 24 weeks
Fluticasone Furoate Inhalation Powder
Fluticasone furoate inhalation powder inhaled orally once daily for 24 weeks
Fluticasone Propionate Inhalation Powder
Fluticasone propionate inhalation powder inhaled orally twice daily for 24 weeks
Placebo Inhalation Powder 1
Placebo in novel dry powder inhaler once daily
Placebo Inhalation Powder 2
Placebo in Diskus inhaler twice daily
Eligibility Criteria
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Inclusion Criteria
* Both genders; females of childbearing potential must be willing to use birth control method
* Pre-bronchodilator FEV1 of 40-90% predicted
* Reversibility FEV1 of at least 12% and 200mls
* Current asthma therapy that includes an inhaled corticosteroid for at least 12 weeks prior to first visit
Exclusion Criteria
* Respiratory infection or oral candidiasis
* Asthma exacerbation within 12 weeks
* Concurrent respiratory disease or other disease that would confound study participation or affect subject safety
* Allergies to study drugs, study drugs' excipients, medications related to study drugs
* Taking another investigational medication or medication prohibited for use during this study
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
Bell Gardens, California, United States
GSK Investigational Site
Huntington Beach, California, United States
GSK Investigational Site
Long Beach, California, United States
GSK Investigational Site
Los Angeles, California, United States
GSK Investigational Site
Riverside, California, United States
GSK Investigational Site
Roseville, California, United States
GSK Investigational Site
San Diego, California, United States
GSK Investigational Site
Clearwater, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Panama City, Florida, United States
GSK Investigational Site
Atlanta, Georgia, United States
GSK Investigational Site
Normal, Illinois, United States
GSK Investigational Site
River Forest, Illinois, United States
GSK Investigational Site
Asheville, North Carolina, United States
GSK Investigational Site
Cincinnati, Ohio, United States
GSK Investigational Site
Oklahoma City, Oklahoma, United States
GSK Investigational Site
Oklahoma City, Oklahoma, United States
GSK Investigational Site
Lake Oswego, Oregon, 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
El Paso, Texas, United States
GSK Investigational Site
Sugar Land, Texas, United States
GSK Investigational Site
Cottbus, Brandenburg, Germany
GSK Investigational Site
Schwedt, Brandenburg, Germany
GSK Investigational Site
Hamburg, City state of Hamburg, Germany
GSK Investigational Site
Frankfurt am Main, Hesse, Germany
GSK Investigational Site
Gelnhausen, Hesse, Germany
GSK Investigational Site
Kassel, Hesse, Germany
GSK Investigational Site
Rüsselsheim am Main, Hesse, Germany
GSK Investigational Site
Hanover, Lower Saxony, Germany
GSK Investigational Site
Geesthacht, Schleswig-Holstein, Germany
GSK Investigational Site
Lübeck, Schleswig-Holstein, Germany
GSK Investigational Site
Fukuoka, , Japan
GSK Investigational Site
Hiroshima, , Japan
GSK Investigational Site
Hyōgo, , Japan
GSK Investigational Site
Ishikawa, , Japan
GSK Investigational Site
Kagawa, , Japan
GSK Investigational Site
Kyoto, , Japan
GSK Investigational Site
Okayama, , Japan
GSK Investigational Site
Okinawa, , Japan
GSK Investigational Site
Shizuoka, , Japan
GSK Investigational Site
Shizuoka, , Japan
GSK Investigational Site
Tokyo, , Japan
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Tokyo, , Japan
GSK Investigational Site
Bialystok, , Poland
GSK Investigational Site
Działdowo, , Poland
GSK Investigational Site
Gdansk, , Poland
GSK Investigational Site
Gdansk, , Poland
GSK Investigational Site
Gliwice, , Poland
GSK Investigational Site
Krakow, , Poland
GSK Investigational Site
Piekary Śląskie, , Poland
GSK Investigational Site
Sopot, , Poland
GSK Investigational Site
Bucharest, , Romania
GSK Investigational Site
Bucharest, , Romania
GSK Investigational Site
Iași, , Romania
GSK Investigational Site
Oradea, , Romania
GSK Investigational Site
Ploieşti, , Romania
GSK Investigational Site
Suceava, , Romania
GSK Investigational Site
Timișoara, , Romania
GSK Investigational Site
Kazan', , Russia
GSK Investigational Site
Moscow, , Russia
GSK Investigational Site
Moscow, , Russia
GSK Investigational Site
Moscow, , Russia
GSK Investigational Site
Moscow, , Russia
GSK Investigational Site
Moscow, , Russia
GSK Investigational Site
Ryazan, , Russia
GSK Investigational Site
Saint Petersburg, , Russia
GSK Investigational Site
Smolensk, , Russia
GSK Investigational Site
Yaroslavl, , Russia
GSK Investigational Site
Yekaterinburg, , Russia
Countries
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References
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Kosinski M, Nelsen L, Rizio AA, Lay-Flurrie J, von Maltzahn R, Jacques L, Schatz M, Stanford RH, Svedsater H. Psychometric properties of the Asthma Control Test in 2 randomized clinical trials. J Allergy Clin Immunol Pract. 2021 Jan;9(1):561-563.e1. doi: 10.1016/j.jaip.2020.07.040. Epub 2020 Aug 6. No abstract available.
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.
Gross AS, Goldfrad C, Hozawa S, James MH, Clifton CS, Sugiyama Y, Jacques L. Ethnic sensitivity assessment of fluticasone furoate/vilanterol in East Asian asthma patients from randomized double-blind multicentre Phase IIb/III trials. BMC Pulm Med. 2015 Dec 24;15:165. doi: 10.1186/s12890-015-0159-z.
O'Byrne PM, Bleecker ER, Bateman ED, Busse WW, Woodcock A, Forth R, Toler WT, Jacques L, Lotvall J. Once-daily fluticasone furoate alone or combined with vilanterol in persistent asthma. Eur Respir J. 2014 Mar;43(3):773-82. doi: 10.1183/09031936.00064513. Epub 2013 Oct 17.
Study Documents
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Document Type: Dataset Specification
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: Individual Participant Data Set
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: Annotated Case Report Form
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 DocumentRelated Links
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Other Identifiers
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106829
Identifier Type: -
Identifier Source: org_study_id
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