Abstract
BackgroundFluticasone furoate is a once-daily inhaled corticosteroid. This report provides an overview of safety and efficacy data that support the use of once-daily fluticasone furoate 100 μg or 200 μg in adult and adolescent asthma patients.MethodsFourteen clinical studies (six Phase II and eight Phase III) were conducted as part of the fluticasone furoate global clinical development programme in asthma. Safety data from 10 parallel-group, randomised, double-blind Phase II and III studies (including 3345 patients who received at least one dose of fluticasone furoate) were integrated to provide information on adverse events, withdrawals, laboratory assessments, vital signs and hypothalamic-pituitary-adrenal axis function. The efficacy of once-daily fluticasone furoate was evaluated in all included studies.ResultsOnce-daily fluticasone furoate 100 μg and 200 μg safety profiles were consistent with those reported for other inhaled corticosteroids, and both doses consistently demonstrated efficacy versus placebo. In the integrated analysis, no dose-response relationship was observed for the overall incidence of adverse events and there were no significant effects of fluticasone furoate on hypothalamic-pituitary-adrenal axis function.ConclusionOnce-daily fluticasone furoate 100 μg and 200 μg had acceptable safety profiles and was efficacious in adult and adolescent patients with asthma. There was no evidence of cortisol suppression at studied doses.Trial registrationsGSK (NCT01499446/FFA20001, NCT00398645/FFA106783, NCT00766090/112202, NCT00603746/FFA109684, NCT00603278/FFA109685, NCT00603382/FFA109687, NCT01436071/115283, NCT01436110/115285, NCT01159912/112059, NCT01431950/114496, NCT01165138/HZA106827, NCT01086384/106837, NCT01134042/HZA106829 and NCT01244984/1139879).Electronic supplementary materialThe online version of this article (doi:10.1186/s12931-016-0473-x) contains supplementary material, which is available to authorized users.
Highlights
Fluticasone furoate is a once-daily inhaled corticosteroid
Pneumonia was pre-specified as an adverse events (AEs) of special interest (AESI) because it has been reported as an Inhaled corticosteroids (ICS)-related event in chronic obstructive pulmonary disease, but no clear association has been identified with the use of ICS and pneumonia in asthma [31]
The incidence of pneumonia was low (
Summary
Fluticasone furoate is a once-daily inhaled corticosteroid. This report provides an overview of safety and efficacy data that support the use of once-daily fluticasone furoate 100 μg or 200 μg in adult and adolescent asthma patients. Inhaled corticosteroids (ICS) are the mainstay of treatment for all severities of persistent asthma, leading to improved symptom control, improved lung function and quality of life, and reduced asthma mortality [1]. The ICS fluticasone furoate (FF), administered using the ELLIPTA® dry powder inhaler, is a once-daily maintenance treatment for adult and adolescent (≥12 years) patients with asthma. FF has higher cellular accumulation and slower efflux compared with other corticosteroids [5], resulting in enhanced lung residency and 24-h efficacy in patients with asthma [6,7,8]. FF 100 μg or 200 μg is approved as monotherapy in a number of countries, including the USA [9], and in combination with vilanterol, a novel long-acting beta agonist, as asthma maintenance therapy in multiple countries, including the USA and in the EU [10,11,12]
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