Effect of a Novel Selective Inhaled Steroid on the Allergen-Induced Early and Late Asthmatic Response in Adults with Mild Asthma: A Randomised Study
Philippe Bareille, Ann Allen, Kelly Hardes and Alison DonaldAffiliation:
Medicines Discovery and Development, Gunnels Wood Road, Stevenage, Herts, SG1 2NY, United Kingdom.
Aim: The objective was to assess the effect of inhaled doses of GW870086, a novel selective corticosteroid, on allergen-induced early and late asthmatic responses (EAR/LAR).
Methods: Twenty-four males with mild asthma were randomised in a double-blind, three-way crossover study to receive GW870086 0.25 mg, 1 mg and 3 mg once-daily, fluticasone propionate (FP) 0.25 mg twice-daily or placebo for 13 days.
Results: Change from baseline in weighted mean LAR (95% CI) were -0.340 L (-0.567, -0.113), -0.396 L (-0.626, -0.167) and -0.248 L (-0.471,-0.024) for GW870086 0.25 mg, 1 mg and 3 mg, respectively, -0.146 L (-0.371, 0.078) for FP 0.25 mg and -0.550 L (-0.744, -0.356) for placebo. Reductions (vs. placebo) for GW870086 0.25 mg and 3 mg, and FP 0.25 mg achieved statistical significance. GW870086 3 mg demonstrated attenuation of the weighted mean EAR (- 0.634 L [-0.885; -0.383]); however, compared with placebo this was not significant. Methacholine PC20 was significantly increased (vs. placebo) after GW870086 3 mg and FP 0.25 mg. Exhaled NO was reduced (vs. placebo), achieving statistical significance after all treatments.
Conclusion: GW870086 3 mg demonstrated anti-inflammatory activity and offered protection from airway hyperresponsiveness.
Allergen challenge, early asthmatic response, GW870086, late asthmatic response.
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