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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Placebo; Drug: Fluticasone propionate 100mcg; Drug: Fluticasone furoate 50mcg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01436110

115285

Details and patient eligibility

About

A randomised, double-blind, double-dummy, placebo controlled multi-centre study to evaluate the efficacy and safety of fluticasone furoate inhalation powder and fluticasone propionate inhalation powder in the treatment of asthma in adults and adolescents not currently treated with inhaled corticosteroids

Full description

This will be a multi-centre, randomised, placebo and active controlled (with rescue medication), double-blind, double-dummy, parallel-group study. Subjects meeting all the inclusion criteria and none of the exclusion criteria during Visit 1 (Screening Visit) will enter a two week Run-in Period. Subjects failing screening will not be eligible for re-screening. During the run-in and double-blind treatment periods subjects will maintain an electronic daily diary to record morning and evening peak expiratory flow (PEF), asthma symptom scores and rescue albuterol/salbutamol use. At Visit 2 (end of run-in/Randomisation Visit), subjects meeting the eligibility criteria will be randomised receive treatment with either fluticasone furoate 50 mcg once daily, fluticasone propionate 100 mcg twice daily or placebo. In addition all subjects will be supplied with albuterol/salbutamol inhalation aerosol to use as required to treat symptoms. Subjects will attend 6 on-treatment visits at Visits 3, 4, 5, 6, 7 and 8 (Weeks 2, 4, 8, 12, 18 and 24 respectively). Subjects will receive treatment for 24 weeks. A follow-up contact will be performed 1-week after completing study medication (Visit 9). Subjects will participate in the study for up to a maximum of 27 weeks (including screening, treatment and follow-up contact).

Enrollment: 351 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent
• Outpatient at least 12 years of age with a 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 during the study
• Pre-bronchodilator FEV1 of at least 60% predicted
• FEV1 reversibility of at least 12% and 200ml
• Current asthma therapy that includes a non-corticosteroid controller and/or short acting beta-agonist

Exclusion criteria

• History of life-threatening asthma exacerbation with the past 10 years
• Asthma exacerbation requiring oral corticosteroids within the past 3 months or overnight hospital stay within the past 6 months
• Current or recent respiratory infection or current oral candida infection
• Presence of a significant respiratory disease or other medical condition that is uncontrolled or that could affect subject safety or study outcome
• Known or suspected allergy to study medication or materials
• Taking another investigational medication or prohibited medication during the study
• Current smokers or former smokers with significant tobacco exposure
• Previous treatment with fluticasone furoate in a phase II or III study
• Children in Care

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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351 participants in 3 patient groups, including a placebo group

Fluticasone furoate 50 mcg

Experimental group

Description:

Once daily inhalation powder via Novel Dry Powder Inhaler

Treatment:

Drug: Fluticasone furoate 50mcg

Fluticasone propionate 100mcg

Active Comparator group

Description:

Twice daily inhalation powder via DISKUS/ ACCUHALER

Treatment:

Drug: Fluticasone propionate 100mcg

Placebo

Placebo Comparator group

Description:

Inhalation Powder via Novel Dry Powder Inhaler and DISKUS/ ACCUHALER

Treatment:

Drug: Placebo