Evaluating the Efficacy and Safety of Fluticasone Furoate in the Treatment of Asthma in Adults and Adolescents

Completed · Phase 3

Conditions studied: Asthma

In brief

A randomised, double-blind, multi-centre study to evaluate the efficacy and safety of two doses of inhaled fluticasone furoate in the treatment of persistent asthma in adults and adolescents currently receiving mid to high strength inhaled corticosteroids.

Key facts

Study ID

NCT01431950

Run by

GlaxoSmithKline

People needed

238

Starts

2011-09-01

Expected to finish

2012-10-01

Last updated by the study team

2017-01-09

Who can join

Age: 12 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent
• Outpatient at least 12 years of age with 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
• Pre-bronchodilator FEV1 of 40-90% predicted
• Reversibility FEV1 of at least 12% and 200mLs
• Current asthma therapy that includes inhaled corticosteroid for at least 4 weeks prior to first visit

You may not qualify if…

• History of life threatening asthma
• Respiratory infection or candidiasis
• Asthma exacerbation requiring OCS within last 4 weeks or overnight hospital stay within the last 3 months
• Concurrent respiratory disease or other disease that would confound study participation of affect subject safety
• Allergies to study drugs, study drug excipients, medications related to study drugs
• Taking another investigational medication or medication prohibited for use during the study
• Previous treatment with FF or FF/VI in a phase II or III study
• Night shift workers
• Children in care

Where it is running

• GSK Investigational Site — Long Beach, California, United States
• GSK Investigational Site — Newport Beach, California, United States
• GSK Investigational Site — Colorado Springs, Colorado, United States
• GSK Investigational Site — Clearwater, Florida, United States
• GSK Investigational Site — Albany, Georgia, United States
• GSK Investigational Site — Lexington, Kentucky, 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 — Plymouth, Minnesota, 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 — Canton, Ohio, United States
• GSK Investigational Site — Cincinnati, Ohio, United States
• GSK Investigational Site — Toledo, Ohio, United States
• GSK Investigational Site — Oklahoma City, Oklahoma, United States
• GSK Investigational Site — Orangeburg, South Carolina, United States
• GSK Investigational Site — Corsicana, Texas, United States
• GSK Investigational Site — Mendoza, Mendoza Province, Argentina
• GSK Investigational Site — Buenos Aires, Argentina
• GSK Investigational Site — Buenos Aires, Argentina
• GSK Investigational Site — Buenos Aires, Argentina
• GSK Investigational Site — San Miguel de Tucumán, Argentina
• GSK Investigational Site — Puente Alto - Santiago, Región Metro de Santiago, Chile

Full record on ClinicalTrials.gov

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