Fluticasone propionate HFA improves asthma control in children aged 4 to 11 years with asthma

Abstract Rationale To evaluate the efficacy of fluticasone propionate HFA 88μg BID (FP) vs placebo HFA (PLA) for 12 weeks in children aged 4-11 years with asthma. Methods In this randomized (160 FP: 81 PLA), double-blind, parallel-group, placebo-controlled trial, eligible children had a history of asthma requiring treatment ≥6 months prior to screening, a baseline PEF ≤85% of the Polgar predicted and demonstrated ≥12% reversibility. The primary efficacy measure was mean change from baseline to endpoint in percent predicted AM pre-dose clinic PEF. Secondary and other measures included mean change from baseline in percent predicted FEV 1 (≥6 years only), diary AM/PM PEF, asthma symptom scores, daily rescue albuterol use and nighttime awakenings. A post-hoc analysis was conducted that assessed asthma control using criteria based on NHLBI guidelines (using parameters of clinic PEF, asthma symptoms and albuterol use). Results Patients treated with FP demonstrated a greater improvement in mean percent predicted AM pre-dose clinic PEF (10%) compared with patients who received PLA (4%; p=0.003). Greater improvements were also observed for most secondary and other endpoints and the analysis of improvement in asthma control. At baseline, most patients (77% PLA, 79% FP) met NHLBI criteria for moderate or severe persistent asthma. At the end of treatment, 30% of the FP patients had experienced a ≥two-step improvement or improvement to mild intermittent in asthma staging compared with 16% of patients in the PLA group (p=0.028). Conclusion Treatment with FP HFA 88μg BID for 12 weeks significantly improves asthma control in children aged 4-11 years with asthma.