Clinical Study Evaluating Safety and Efficacy of Fluticasone Furoate and Fluticasone Propionate in People With Asthma

Completed · Phase 3 · Has a placebo group

Conditions studied: Asthma

In brief

A randomised, double-blind, double-dummy, placebo controlled multi-centre study to evaluate the efficacy and safety of fluticasone furoate inhalation powder and fluticasone propionate inhalation powder in the treatment of asthma in adults and adolescents not currently treated with inhaled corticosteroids

Key facts

Study ID

NCT01436110

Run by

GlaxoSmithKline

People needed

351

Starts

2011-09-01

Expected to finish

2012-09-01

Last updated by the study team

2017-01-09

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent
• Outpatient at least 12 years of age with a diagnosis of asthma at least 12 weeks prior to first visit
• Both genders; females of child bearing potential must be willing to use appropriate contraception during the study
• Pre-bronchodilator FEV1 of at least 60% predicted
• FEV1 reversibility of at least 12% and 200ml
• Current asthma therapy that includes a non-corticosteroid controller and/or short acting beta-agonist

You may not qualify if…

• History of life-threatening asthma exacerbation with the past 10 years
• Asthma exacerbation requiring oral corticosteroids within the past 3 months or overnight hospital stay within the past 6 months
• Current or recent respiratory infection or current oral candida infection
• Presence of a significant respiratory disease or other medical condition that is uncontrolled or that could affect subject safety or study outcome
• Known or suspected allergy to study medication or materials
• Taking another investigational medication or prohibited medication during the study
• Current smokers or former smokers with significant tobacco exposure
• Previous treatment with fluticasone furoate in a phase II or III study
• Children in Care

Where it is running

• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Rolling Hills Estates, California, United States
• GSK Investigational Site — Sacramento, California, United States
• GSK Investigational Site — San Jose, California, United States
• GSK Investigational Site — Aventura, Florida, United States
• GSK Investigational Site — Clearwater, Florida, United States
• GSK Investigational Site — Hialeah, Florida, United States
• GSK Investigational Site — Orlando, Florida, United States
• GSK Investigational Site — Metairie, Louisiana, United States
• GSK Investigational Site — Sunset, Louisiana, United States
• GSK Investigational Site — Bethesda, Maryland, United States
• GSK Investigational Site — Columbia, Missouri, United States
• GSK Investigational Site — Las Vegas, Nevada, United States
• GSK Investigational Site — Brick, New Jersey, United States
• GSK Investigational Site — Utica, New York, United States
• GSK Investigational Site — Cincinnati, Ohio, United States
• GSK Investigational Site — Orangeburg, South Carolina, United States
• GSK Investigational Site — Corsicana, Texas, United States
• GSK Investigational Site — El Paso, Texas, United States
• GSK Investigational Site — Waco, Texas, United States
• GSK Investigational Site — Guadalajara, Jalisco, Mexico
• GSK Investigational Site — Zapopan, Jalisco, Mexico
• GSK Investigational Site — Mexico City, Mexico
• GSK Investigational Site — Almelo, Netherlands
• GSK Investigational Site — Eindhoven, Netherlands

Full record on ClinicalTrials.gov

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