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

Completed · Phase 3 · Has a placebo group

Conditions studied: Asthma

In brief

A randomised, double-blind, placebo-controlled (with rescue medication), multi-centre study to evaluate the efficacy and safety of inhaled fluticasone furoate in the treatment of persistent asthma in adults and adolescents not currently receiving inhaled corticosteroids

Key facts

Study ID

NCT01436071

Run by

GlaxoSmithKline

People needed

248

Starts

2011-09-01

Expected to finish

2012-08-01

Last updated by the study team

2017-01-11

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 diagnosis of asthma at least 12 weeks before 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 200mls
• 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 within the past 10 years
• Asthma exacerbation requiring treatment with oral corticosteroids within the last 3 months or that required overnight hospital stay within 6 months
• Current or recent respiratory infection or current oral candida infection
• Presence of another significant respiratory disease or medical condition that is not controlled or that could affect subject safety or study outcome
• Known or suspected allergy to study drug or materials
• Taking another investigational medication or prohibited medication during the study
• Previous treatment with inhaled fluticasone furoate in a phase II or III study
• Current smokers or former smokers with significant tobacco exposure
• Children in Care

Where it is running

• GSK Investigational Site — Long Beach, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Newport Beach, California, United States
• GSK Investigational Site — Albany, Georgia, United States
• GSK Investigational Site — Columbia, Missouri, United States
• GSK Investigational Site — Oklahoma City, Oklahoma, United States
• GSK Investigational Site — Orangeburg, South Carolina, United States
• GSK Investigational Site — Spartanburg, South Carolina, United States
• GSK Investigational Site — Corsicana, Texas, United States
• GSK Investigational Site — Waco, Texas, United States
• GSK Investigational Site — Zapopan, Jalisco, Mexico
• GSK Investigational Site — Morelia, Michoacán, Mexico
• GSK Investigational Site — Villahermosa, Tabasco, Mexico
• GSK Investigational Site — Lima, Lima Province, Peru
• GSK Investigational Site — Lima, Lima Province, Peru
• GSK Investigational Site — Lima, Lima Province, Peru
• GSK Investigational Site — San Borja, Lima region, Peru
• GSK Investigational Site — San Miguel, Lima region, Peru
• GSK Investigational Site — Klin, Russia
• GSK Investigational Site — Moscow, Russia
• GSK Investigational Site — Saint Petersburg, Russia
• GSK Investigational Site — Saratov, Russia
• GSK Investigational Site — Voronezh, Russia
• GSK Investigational Site — Yaroslavl, Russia

Full record on ClinicalTrials.gov

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