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Study HZA106829: Efficacy/Safety Study of Fluticasone Furoate/Vilanterol (GW642444) in Adult and Adolescent Asthmatics | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Study HZA106829: Efficacy/Safety Study of Fluticasone Furoate/Vilanterol (GW642444) in Adult and Adolescent Asthmatics

HZA106829: A Randomised, Double-blind, Parallel Group, Multicentre Study of Fluticasone Furoate/GW642444 Inhalation Powder, Fluticasone Furoate Inhalation Powder Alone, and Fluticasone Propionate Alone in the Treatment of Persistent Asthma in Adults and Adolescents

NCT01134042•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Outpatient at least 12 years of age
•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

•History of life-threatening asthma
•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

Locations (71)

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

Key Dates

Start Date

June 1, 2010

Primary Completion Date

October 1, 2011

Completion Date

October 1, 2011

Last Updated

January 11, 2017

Enrollment

587

ACTUAL participants

Conditions

Asthma

Interventions

Fluticasone Furoate/Vilanterol Inhalation Powder

DRUG

Fluticasone Furoate Inhalation Powder

DRUG

Fluticasone Propionate Inhalation Powder

DRUG

Placebo Inhalation Powder 1

OTHER

Placebo Inhalation Powder 2

OTHER

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

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Asthma

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RECRUITINGPHASE2

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 11, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study HZA106829: Efficacy/Safety Study of Fluticasone Furoate/Vilanterol (GW642444) in Adult and Adolescent Asthmatics

Inclusion Criteria

Exclusion Criteria

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

Relationship of Airway Microbiota, Endotype and Phenotype in Adult Asthma

To Assess the Management of Patients on Global Initiative of Asthma (GINA) Step 4 and 5 Treatment in Hong Kong

A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma