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Managing asthma: inhaled therapy and beyond
P112 Fluticasone propionate/formoterol fumarate combination therapy reduces the risk of exacerbations compared with its individual components in patients with asthma
  1. S Dissanayake1,
  2. J Sastre2,
  3. A Papi3,
  4. K Kaiser4,
  5. B Grothe1,
  6. M Lomax1,
  7. T McIver1
  1. 1Mundipharma Research Limited, Cambridge, UK
  2. 2Fundacion Jimenez Diaz, Madrid, Spain
  3. 3University of Ferrara, Ferrara, Italy
  4. 4SkyePharma, Muttenz, Switzerland

Abstract

Introduction and Objectives Asthma remains uncontrolled in many patients, as indicated by exacerbations, deteriorating symptoms and impaired quality of life. A new option has been developed for the maintenance treatment of asthma, combining the inhaled corticosteroid fluticasone propionate (FLUT) with the long-acting ß2-agonist formoterol fumarate (FORM) in a single aerosol inhaler (FLUT/FORM; flutiform®). A pooled analysis of data from up to five randomised, double-blind, parallel-group phase 3 studies assessed the effects of FLUT/FORM on asthma exacerbations.

Methods Adults and adolescents with mild, moderate or severe asthma were randomised to FLUT/FORM (100/10, 250/10 or 500/20 μg twice daily), the equivalent nominal dose of FLUT monotherapy (100, 250 or 500 μg twice daily; five studies) or FORM monotherapy (10 μg twice daily; three studies) for 8 or 12 weeks. The endpoints assessed were time to first exacerbation and proportion of patients experiencing an exacerbation. Exacerbations were defined as peak expiratory flow rate >30% below baseline, awakening at night due to asthma, use of rescue medication 3–4 times per day (each on =2 consecutive days; mild-to-moderate exacerbation), need for additional therapy, or emergency visit or hospitalisation due to asthma (severe exacerbation).

Results Time to first exacerbation (any severity) was significantly longer with FLUT/FORM (n=641) than with FLUT (n=643; p=0.01). Similarly, time to first exacerbation was significantly longer with FLUT/FORM (n=341) than FORM (n=345; p<0.001). Overall, the proportion of patients with any exacerbation was significantly lower with FLUT/FORM (18.2%) than with FORM (31.3%; p<0.001). Fewer patients experienced severe exacerbations with FLUT/FORM than FORM alone (FLUT/FORM 2.4%; FORM 9.6%; p<0.001). Similarly, fewer patients experienced any exacerbation with FLUT/FORM (26.8%) than with FLUT (32.8%; p=0.02) and fewer patients experienced severe exacerbations with FLUT/FORM than FLUT alone (FLUT/FORM 1.9%; FLUT 2.8%; p=0.36).

Conclusions Fluticasone/formoterol significantly reduces the risk of asthma exacerbations compared with its individual components. Combination therapy with fluticasone and formoterol in a single aerosol inhaler may help to improve asthma control and reduce the risk of asthma exacerbations that can impair patients' quality of life.

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