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

Completed · Phase 3 · Has a placebo group

Conditions studied: Asthma

In brief

A randomised, double-blind, double-dummy, placebo controlled (with rescue medication), multicenter study to evaluate the efficacy and safety of Fluticasone Furoate inhalation powder in the treatment of persistent asthma in adults and adolescents.

Key facts

Study ID

NCT01159912

Run by

GlaxoSmithKline

People needed

350

Starts

2010-06-30

Expected to finish

2012-01-16

Last updated by the study team

2017-11-09

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
• Both genders; females of child bearing potential must be willing to use approved 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 4 weeks prior to first visit

You may not qualify if…

• History of life threatening asthma
• Respiratory infection or candidiasis
• Asthma exacerbation within 6 months prior to first visit
• Concurrent respiratory disease or other disease that would confound study participation or 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 this study

Where it is running

• GSK Investigational Site — Montgomery, Alabama, United States
• GSK Investigational Site — Green Valley, Arizona, United States
• GSK Investigational Site — Little Rock, Arkansas, United States
• GSK Investigational Site — Bakersfield, California, United States
• GSK Investigational Site — Encinitas, California, United States
• GSK Investigational Site — Fresno, California, United States
• GSK Investigational Site — Huntington Beach, California, United States
• GSK Investigational Site — Long Beach, California, United States
• GSK Investigational Site — Long Beach, California, United States
• GSK Investigational Site — Newport Beach, California, United States
• GSK Investigational Site — Orange, California, United States
• GSK Investigational Site — Riverside, California, United States
• GSK Investigational Site — Rolling Hills Estates, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — San Jose, California, United States
• GSK Investigational Site — Cutler Bay, Florida, United States
• GSK Investigational Site — Edgewater, Florida, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Orlando, Florida, United States
• GSK Investigational Site — Albany, Georgia, United States
• GSK Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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