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HZA113091 Efficacy and Safety of Fluticasone Furoate/Vilanterol (GW642444) in Adults and Adolescents

NCT ID: NCT01147848

Last Updated: 2017-01-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

810 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-07-31

Brief Summary

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The purpose of the study is to compare the efficacy and safety of fluticasone furoate/vilanterol (GW642444) inhalation powder administered once daily with fluticasone propionate/salmeterol administered twice daily in adolescent and adult subjects 12 years of age and older with persistent bronchial asthma over a 24-week period.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Fluticasone furoate/Vilanterol (GW642444)

Fluticasone furoate/vilanterol inhalation powder once daily + placebo inhalation powder twice daily for 24 weeks

Group Type EXPERIMENTAL

Fluticasone furoate/Vilanterol Inhalation Powder

Intervention Type DRUG

Fluticasone furoate/Vilanterol Inhalation Powder inhaled orally once daily for 24 weeks

Placebo (2)

Intervention Type DRUG

Inhalation powder inhaled orally twice daily for 24 weeks

Fluticasone propionate/salmeterol

Fluticasone propionate/salmeterol inhalation powder twice daily + placebo inhalation powder once daily for 24 weeks

Group Type ACTIVE_COMPARATOR

Fluticasone propionate/salmeterol Inhalation Powder

Intervention Type DRUG

Fluticasone propionate/salmeterol Inhalation Powder inhaled orally twice daily for 24 weeks

Placebo (1)

Intervention Type DRUG

Inhalation powder inhaled orally once daily for 24 weeks

Interventions

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Fluticasone furoate/Vilanterol Inhalation Powder

Fluticasone furoate/Vilanterol Inhalation Powder inhaled orally once daily for 24 weeks

Intervention Type DRUG

Fluticasone propionate/salmeterol Inhalation Powder

Fluticasone propionate/salmeterol Inhalation Powder inhaled orally twice daily for 24 weeks

Intervention Type DRUG

Placebo (1)

Inhalation powder inhaled orally once daily for 24 weeks

Intervention Type DRUG

Placebo (2)

Inhalation powder inhaled orally twice daily for 24 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of asthma
* Reversibility of at least 12% and at least 200mLs within 10-40 minutes following 2-4 inhalations of albuterol
* FEV1 of 40-85% predicted normal
* Currently using inhaled corticosteroid therapy

Exclusion Criteria

* History of life-threatening asthma within previous 5 years (requiring intubation and/or was associated with hypercapnoea, respiratory arrest or hypoxic seizures)
* Respiratory infection or oral candidiasis
* Asthma exacerbation requiring oral corticosteroids or that resulted in overnight hospitalisation requiring additional asthma treatment
* Uncontrolled disease or clinical abnormality
* Allergies
* Taking another investigational medication or prohibited medication
* Night shift workers
* Current smokers or subjects with smoking history of at least 10 pack years
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Huntington Beach, California, United States

Site Status

GSK Investigational Site

Los Angeles, California, United States

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Los Angeles, California, United States

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Riverside, California, United States

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Rolling Hills Estates, California, United States

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San Diego, California, United States

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Centennial, Colorado, United States

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Denver, Colorado, United States

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Cocoa, Florida, United States

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Bethesda, Maryland, United States

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Wheaton, Maryland, United States

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Rolla, Missouri, United States

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St Louis, Missouri, United States

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Cherry Hill, New Jersey, United States

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Skillman, New Jersey, United States

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Raleigh, North Carolina, United States

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Cincinnati, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Medford, Oregon, United States

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Greenville, South Carolina, United States

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Orangeburg, South Carolina, United States

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Spartanburg, South Carolina, United States

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Austin, Texas, United States

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San Antonio, Texas, United States

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Waco, Texas, United States

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Buenos Aires, Buenos Aires, Argentina

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Buenos Aires, Buenos Aires, Argentina

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Quilmes, Buenos Aires, Argentina

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Paraná, Entre Ríos Province, Argentina

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Mendoza, Mendoza Province, Argentina

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Rosario, Santa Fe Province, Argentina

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Rosario, Santa Fe Province, Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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San Miguel de Tucumán, , Argentina

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Rancagua, Reg Del Libert Bern Ohiggins, Chile

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Valparaíso, Región de Valparaíso, Chile

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Viña del Mar, Región de Valparaíso, Chile

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Puente Alto - Santiago, Región Metro de Santiago, Chile

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Santiago, Región Metro de Santiago, Chile

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Santiago, Región Metro de Santiago, Chile

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Santiago, Región Metro de Santiago, Chile

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Almelo, , Netherlands

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Breda, , Netherlands

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Dordrecht, , Netherlands

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Eindhoven, , Netherlands

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Harderwijk, , Netherlands

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Heerlen, , Netherlands

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Hoorn, , Netherlands

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Veldhoven, , Netherlands

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Cabanatuan City, Nueva Ecija, , Philippines

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Cebu City, , Philippines

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Dasmariñas, Cavite, , Philippines

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Manila, , Philippines

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Marilao, Bulacan, , Philippines

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GSK Investigational Site

Quezon City, , Philippines

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GSK Investigational Site

Cheongju, Chungcheongbuk-do, , South Korea

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GSK Investigational Site

Incheon, , South Korea

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GSK Investigational Site

Kangwon-do, , South Korea

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GSK Investigational Site

Seoul, , South Korea

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GSK Investigational Site

Seoul, , South Korea

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GSK Investigational Site

Seoul, , South Korea

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GSK Investigational Site

Suwon, Kyonggi-do, , South Korea

Site Status

Countries

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United States Argentina Chile Netherlands Philippines South Korea

References

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Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.

Reference Type DERIVED
PMID: 36472162 (View on PubMed)

Woodcock A, Bleecker ER, Lotvall J, O'Byrne PM, Bateman ED, Medley H, Ellsworth A, Jacques L, Busse WW. Efficacy and safety of fluticasone furoate/vilanterol compared with fluticasone propionate/salmeterol combination in adult and adolescent patients with persistent asthma: a randomized trial. Chest. 2013 Oct;144(4):1222-1229. doi: 10.1378/chest.13-0178.

Reference Type DERIVED
PMID: 23846316 (View on PubMed)

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 Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

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113091

Identifier Type: -

Identifier Source: org_study_id

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