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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Asthma

Treatments

Drug: Fluticasone furoate 50mcg

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01436071

115283

Details and patient eligibility

About

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

Full description

This will be a multi-centre, randomised, placebo controlled (with rescue medication), double-blind, 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 score and rescue albuterol/salbutamol use. At Visit 2 (end of run-in/Randomisation Visit), subjects meeting the eligibility criteria will be randomised to either inhaled Fluticasone Furoate 50 mcg or inhaled placebo. In addition all subjects will be supplied with albuterol/salbutamol inhalation aerosol to use as required to treat symptoms. Subjects will attend 4 on-treatment visits at Visits 3, 4, 5, and 6 (Weeks 2, 4, 8 and 12 respectively). Subjects will receive treatment for 84 days (12 weeks). A follow-up contact will be performed 1-week after completing study medication (Visit 7). Subjects will participate in the study for up to a maximum of 15 weeks (including screening, treatment and follow-up contact).

Enrollment

248 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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