This randomized, double-blind study evaluated airway inflammation following administration of fluticasone propionate (FP) 100mcg BID or FP 100mcg BID + montelukast (MON) 10mg QD for 12 weeks in 103 subjects with persistent asthma who were symptomatic on short-acting beta2-agonists.
Subjects underwent biopsy and BAL at baseline and after 12 weeks of treatment with FP or FP+MON.
Furthermore, clinical asthma control, as assessed by AM and PM PEF, FEV1, albuterol use and rescue-free days was similar with FP+MON compared with FP alone.
There was no evidence of incremental improvement in airway inflammation or overall asthma control with the addition of montelukast 10mg QD to FP 100mcg BID.
The common practice of adding a leukotriene modifier to current ICS therapy for broader coverage of inflammation is not supported by this study. The broad anti-inflammatory effects of ICS adequately control the underlying airway inflammation of asthma. (FPD40014).
Paul Dorinsky, Shareholder shareholder of GSK stock; Employee employee of GSK.Median Change at EndpointFP 100 mcg BID (n=53)FP+MON 10mg QD (n=50)p ValueEosinophils* Baseline Change8.93 -8.277.61 -6.880.616Basement membrane thickness (μm) Baseline Change8.21 0.928.99 0.740.743Mast cells*†Baseline Change25.22 -5.2429.27 -14.980.005Neutrophils* Baseline Change21.43 19.2221.85 20.920.752CD3+* Baseline Change53.39 -34.0948.12 -49.430.303CD4+* Baseline Change29.41 -21.9424.30 -24.240.603CD8+* Baseline Change20.59 -13.6117.70 -16.500.510CD25+* Baseline Change0.00 -0.470.57 -0.530.266*
Cells in submucosa/mm2;†