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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Fluticasone propionate; Drug: Placebo; Drug: Fluticasone furoate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01159912

112059

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 350 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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350 participants in 3 patient groups, including a placebo group

Fluticasone Furoate OD and Placebo BID

Experimental group

Description:

Fluticasone furoate inhalation powder once daily and placebo inhalation powder twice daily for 24 weeks

Treatment:

Drug: Placebo

Drug: Fluticasone furoate

Fluticasone Propionate BID and Placebo OD

Active Comparator group

Description:

Fluticasone propionate inhalation powder twice daily and placebo inhalation powder once daily for 24 weeks

Treatment:

Drug: Placebo

Drug: Fluticasone propionate

Placebo only BID

Placebo Comparator group

Description:

Placebo inhalation powder twice daily for 24 weeks

Treatment:

Drug: Placebo