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Study HZA106827: Efficacy/Safety Study of Fluticasone Furoate/Vilanterol (GW642444) in Adult and Adolescent Asthmatics

NCT ID: NCT01165138

Last Updated: 2018-02-14

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

612 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-20

Study Completion Date

2011-10-19

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 and fluticasone furoate inhalation powder both administered once daily in adolescent and adult subjects 12 years of age and older with persistent bronchial asthma over a 12 week treatment 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 for 12 weeks

Group Type EXPERIMENTAL

Fluticasone furoate/Vilanterol Inhalation Powder

Intervention Type DRUG

Fluticasone furoate/Vilanterol Inhalation Powder inhaled orally once daily for 12 weeks

Fluticasone Furoate

Fluticasone furoate inhalation powder once daily for 12 weeks

Group Type EXPERIMENTAL

Fluticasone Furoate Inhalation Powder

Intervention Type DRUG

Fluticasone Furoate Inhalation Powder inhaled orally once daily for 12 weeks

Placebo

Placebo inhalation powder once daily for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo Inhaltion Powder

Intervention Type DRUG

Placebo Inhaltion Powder inhaled orally once daily for 12 weeks

Interventions

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Fluticasone furoate/Vilanterol Inhalation Powder

Fluticasone furoate/Vilanterol Inhalation Powder inhaled orally once daily for 12 weeks

Intervention Type DRUG

Fluticasone Furoate Inhalation Powder

Fluticasone Furoate Inhalation Powder inhaled orally once daily for 12 weeks

Intervention Type DRUG

Placebo Inhaltion Powder

Placebo Inhaltion Powder inhaled orally once daily for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Outpatients at least 12 years of age
* Male and female; female subjects of childbearing potential must be willing to use birth control
* Pre-bronchodilator FEV1 of 40-90% predicted normal
* Reversibility FEV1 of at least 12% and 200mL
* Current asthma therapy includes inhaled corticosteroid use for at least 12 weeks prior to first visit

Exclusion Criteria

* History of life-threatening asthma during last 10 years
* Respiratory infection or oral candidiasis
* Asthma exacerbation requiring oral corticosteroids or that required overnight hospitalisation requiring additional asthma treatment
* Uncontrolled disease or clinical abnormality
* Allergies to study drugs or the excipients
* Taking another investigational medication or prohibited medication
* Night shift workers
* Current smokers or subjects with a 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

Bell Gardens, California, United States

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Huntington Beach, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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Newport Beach, California, United States

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Riverside, California, United States

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Roseville, California, United States

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San Diego, California, United States

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Miami, Florida, United States

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Normal, Illinois, United States

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River Forest, Illinois, United States

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Columbia, Maryland, United States

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Rolla, Missouri, United States

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Cincinnati, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Lake Oswego, Oregon, United States

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Medford, Oregon, United States

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Portland, Oregon, United States

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Orangeburg, South Carolina, United States

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Austin, Texas, United States

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Sugar Land, Texas, United States

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Murray, Utah, United States

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Mannheim, Baden-Wurttemberg, Germany

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Oranienburg, Brandenburg, Germany

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Frankfurt am Main, Hesse, Germany

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Gelnhausen, Hesse, Germany

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Dresden, Saxony, Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Hamburg, , Germany

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Fukuoka, , Japan

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Hiroshima, , Japan

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Hokkaido, , Japan

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Hyōgo, , Japan

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Ishikawa, , Japan

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Kagawa, , Japan

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Kanagawa, , Japan

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Kyoto, , Japan

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Okinawa, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tarnów, , Poland

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Tczew, , Poland

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Wroclaw, , Poland

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Zawadzkie, , Poland

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Bucharest, , Romania

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Cluj-Napoca, , Romania

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Craiova, , Romania

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Deva, , Romania

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Piteşti, , Romania

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Ploieşti, , Romania

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Suceava, , Romania

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Timișoara, , Romania

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Dnipropetrovsk, , Ukraine

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Dnipropetrovsk, , Ukraine

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Ivano-Frankivsk, , Ukraine

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Kharkiv, , Ukraine

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Kiev, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Simferopol, , Ukraine

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GSK Investigational Site

Zaporizhia, , Ukraine

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Countries

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United States Germany Japan Poland Romania Ukraine

References

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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.

Reference Type DERIVED
PMID: 27881132 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26704701 (View on PubMed)

Bleecker ER, Lotvall J, O'Byrne PM, Woodcock A, Busse WW, Kerwin EM, Forth R, Medley HV, Nunn C, Jacques L, Bateman ED. Fluticasone furoate-vilanterol 100-25 mcg compared with fluticasone furoate 100 mcg in asthma: a randomized trial. J Allergy Clin Immunol Pract. 2014 Sep-Oct;2(5):553-61. doi: 10.1016/j.jaip.2014.02.010. Epub 2014 Apr 24.

Reference Type DERIVED
PMID: 25213048 (View on PubMed)

Svedsater H, Jacques L, Goldfrad C, Bleecker ER. Ease of use of the ELLIPTA dry powder inhaler: data from three randomised controlled trials in patients with asthma. NPJ Prim Care Respir Med. 2014 Jun 26;24:14019. doi: 10.1038/npjpcrm.2014.19. No abstract available.

Reference Type DERIVED
PMID: 24966061 (View on PubMed)

Svedsater H, Dale P, Garrill K, Walker R, Woepse MW. Qualitative assessment of attributes and ease of use of the ELLIPTA dry powder inhaler for delivery of maintenance therapy for asthma and COPD. BMC Pulm Med. 2013 Dec 7;13:72. doi: 10.1186/1471-2466-13-72.

Reference Type DERIVED
PMID: 24314123 (View on PubMed)

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 Document

Document Type: Statistical Analysis Plan

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: Individual Participant Data Set

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: Study Protocol

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

View Document

Document Type: Dataset Specification

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

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Other Identifiers

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106827

Identifier Type: -

Identifier Source: org_study_id

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