Fluticasone propionate (FP) was superior to montelukast (MON) in producing at least a 2-step improvement in asthma severity in children 6-12 years of age

Abstract

Rationale Asthma is characterized by symptoms that vary in severity from patient to patient and within a patient over time. As such, the NHLBI guidelines recommend a stepwise approach for the diagnosis and management of asthma in children, with the goal of pharmacotherapy to reduce symptoms and achieve near normal lung function. Patients may be classified according to severity based on their lung function, symptoms, and rescue albuterol use. An analysis was conducted to evaluate the step change in asthma severity from baseline to endpoint following treatment with FP or MON in children 6-12 years of age. Methods This was a randomized, double-blind, double-dummy, parallel group, 12-week study comparing FP (50μg BID; n=172) with MON (5mg QD; n=170) in symptomatic children using PRN albuterol. Asthma severity classification was defined according to the NHLBI guidelines and was based on % predicted FEV 1, daytime and nighttime symptoms, and albuterol use. Results At baseline, most patients (96%) in each treatment group met the classification criteria for moderate persistent asthma. At endpoint, significantly more patients (p=0.001) treated with FP (37.6%) demonstrated at least a 2-step improvement in asthma severity or improvement to mild intermittent asthma compared with patients who received MON 5 mg (21.1%). Conclusion FP is more effective in producing a ≥2-step improvement in asthma severity than MON in children 6-12 years of age with persistent asthma resulting in more children with an improvement to mild intermittent asthma.