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



Status:Completed
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:12 - Any
Updated:11/11/2017
Start Date:June 30, 2010
End Date:January 16, 2012

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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.

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.

This is a multi-center, randomized, double-blind, double-dummy, parallel-group study to
compare the efficacy and safety of Fluticasone Furoate Inhalation Powder 100mcg once daily
and Fluticasone Propionate Inhalation Powder 250mcg twice daily with Placebo. Subjects will
participate in the study for up to a maximum of 29 weeks (including screening, treatment and
follow-up contact). The primary endpoint consists of change from baseline in clinic visit
trough (pre-bronchodilator and pre-dose) FEV1 at the end of the 24 week treatment period. The
nominated powered secondary endpoint is the change from baseline in the percentage of
rescue-free 24 hour periods during the 24-week treatment period. Safety assessments include
adverse events, oropharyngeal examinations, clinical chemistry and urine cortisol excretion.
For subjects who have consented for pharmacogenetics, a blood sample will also be taken for
pharmacogenetic analysis.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
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49
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Saint Louis, Missouri 63110
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Albany, Georgia 31707
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Austin, Texas 78705
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Bakersfield, California 93309
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Baltimore, Maryland 21201
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Bellevue, Nebraska 68123
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Birmingham, Alabama 35249
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Canton, Ohio 44708
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1250 South Collegeville Road
Collegeville, Pennsylvania 19426
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Columbia, Missouri 65201
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Columbus, Georgia 31904
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Cutler Bay, Florida 33189
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Dallas, Texas 75230
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Dayton, Ohio 45420
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Edgewater, Florida 32132
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Encinitas, California 92024
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Franklin, Ohio 45005
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Fresno, California 93720
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Green Valley, Arizona 85614
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Greenville, South Carolina 29615
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Houston, Texas 77030
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Huntington Beach, California 92647
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Kerrville, Texas 78028
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Las Vegas, Nevada 89102
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Lenexa, Kansas 66215
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Little Rock, Arkansas 72205
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Long Beach, California 90813
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Medford, Oregon 97504
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Metairie, Louisiana 70006
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Miami, Florida 33136
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Montgomery, Alabama 36109
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Newport Beach, California 92663
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Oklahoma City, Oklahoma 73112
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Orange, California 92868
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Orangeburg, South Carolina 29118
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Orlando, Florida 32806
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Owensboro, Kentucky 42303
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Pittsburgh, Pennsylvania 15213
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Richmond, Virginia 23298
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Riverside, California 92506
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Rolling Hills Estates, California 90274
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San Antonio, Texas 78258
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Shelby, North Carolina 28152
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Shiloh, Illinois 62269
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Sunset, Louisiana 70584
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Waco, Texas 76712
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