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P166 Effects of low-vs high-dose fluticasone/formoterol combination therapy on AMP challenge in asthmatic patients
  1. F Kanniess1,
  2. Z Diamant2,
  3. M Lomax3,
  4. M Jain3
  1. 1Practice for Allergy and Family Medicine, Reinfeld, Germany
  2. 2Department of Respiratory Medicine and Allergology, Skane University Hospital, Lund, Sweden
  3. 3Mundipharma Research Limited, Cambridge, UK

Abstract

Background The ICS fluticasone propionate (FP) and the LABA formoterol fumarate (FORM) have now been combined in a single aerosol inhaler (FP/FORM; flutiform®). The effect of low- (2 puffs 50/5 µg bid) vs high-dose (2 puffs 250/10 µg bid) FP/FORM on airway responsiveness to AMP was compared in an incomplete block, placebo-controlled, 2-way crossover study. Post hoc data analysis from patients who received both FP/FORM doses is presented.

Methods 62 patients (33M, 29F; =18yrs; reversible FEV1 =60% pred.) discontinued maintenance ICS medication for 2 - 3wks; those showing a provocative dose of AMP producing a 20% decline in FEV1 (AMP PD20 FEV1) of <60 mg were randomised to receive 2 of 3 treatments (FP/FORM high-, low-dose or placebo) during 2 periods of 28 ± 3 days each, separated by 2 - 3wks. AMP challenges were performed pre-dose and repeated 12h after last dose at the end of each treatment period. The difference in changes in AMP PD20 FEV1 (day 1 vs day 28) between treatments were compared by an ANCOVA.

Results 15 patients were randomised to receive both high- and low-dose FP/FORM. The change in AMP PD20 FEV1 was greater with FP/FORM high- compared with low-dose (LS means: high dose = 11 mg; 95% CI 4.3, 27.9; low dose = 4.6 mg, 95% CI 1.8, 11.8), with a statistically significant 2.4 fold difference in AMP PD20 FEV1 (1.2 doubling doses) between doses (LS mean: 2.4; 95% CI 1.3, 4.5; p = 0.012). FP/FORM was well-tolerated; only few (mild or moderate) AEs occurred.

Conclusions A significant dose-response was found between low- and high-dose FP/FORM with the higher dose demonstrating a greater reduction in airway responsiveness to AMP.

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