Fluticasone propionate administered via metered-dose inhaler with valved holding chamber and attached facemask is effective in improving asthma control by producing at least a 2-step improvement in asthma staging in pre-school age children with asthma

Abstract

Rationale NHLBI guidelines recommend a stepwise approach for diagnosis and management of asthma in children and adults, with the goal of minimizing symptoms and optimizing lung function. A retrospective analysis was conducted to evaluate the step change in asthma severity from baseline to endpoint following treatment with fluticasone propionate (FP) in pre-school age children. Methods Existing data from 4, multi-center, randomized, double-blind, parallel group trials evaluating FP CFC 88μg (FP 88) versus placebo (propellant alone; PLA), in patients 6-23 (Study 1), 24-47 (Study 2), and 12-47 (Studies 3 and 4) months of age, were pooled for analysis. Treatments were administered via a metered-dose inhaler with valved holding chamber (Aerochamber Plus ™, Optichamber ™, or Babyhaler ™) and attached facemask, twice-daily for 12 weeks, in children with documented symptoms of asthma. Asthma severity classification was defined according to the NHLBI guidelines and was based on daily parental/guardian assessments of the child's daytime and nighttime asthma symptoms and supplemental albuterol use. Results A total of 334 children received PLA and 330 received FP 88. At baseline, most patients (94% PLA and 93% FP 88) met the classification criteria for moderate or severe persistent asthma. At endpoint, more patients treated with FP 88 demonstrated at least a 2-step improvement in or improvement to mild intermittent asthma category compared with patients who received PLA, 45% and 34%, respectively (p=0.007). Conclusion In pre-school age children with moderate to severe persistent asthma, treatment with FP 88μg BID was effective in improving asthma control as demonstrated by a ≥2-step improvement in asthma staging.