BACKGROUND: Because of potential toxicities of inhaled corticosteroid (ICS) use in pediatric asthma, alternative or steroid-sparing therapy is desirable. There are no previous studies evaluating montelukast's steroid-sparing effects in children with asthma. OBJECTIVE: To evaluate whether (1) montelukast as add-on therapy improves asthma symptom control and (2) montelukast provides steroid-sparing effects in children with asthma treated with low to moderate doses of ICS therapy. METHODS: In a double-blind, placebo-controlled trial, 36 children ages 6 to 14 years with symptomatic asthma maintained on a stable low to moderate dose of ICSs were randomly assigned to receive montelukast or matching placebo for 24 weeks after a run-in period of 2 weeks (period I). During the trial, subjects kept daily asthma diary cards and monthly spirometry was performed. After a 4 week add-on period (period II), the subjects completed a 20-week (period III) ICS tapering period based on a predetermined protocol. RESULTS: In period II, the difference in the number of rescue-free days was significantly higher in the montelukast group (P = 0.0001), and the number of rescue-free days per week was also significantly higher in montelukast-treated subjects compared with placebo subjects (P = 0.002). In period III, the percentage reduction in ICS dose was not significant between montelukast and placebo (P = 0.10), but the montelukast group experienced an average 17% decrease in ICS dose and the control group experienced an average 64% increase in ICS dose. CONCLUSIONS:Montelukast treatment significantly increased the number of rescue-free days in symptomatic children with asthma.
RCT Entities:
BACKGROUND: Because of potential toxicities of inhaled corticosteroid (ICS) use in pediatric asthma, alternative or steroid-sparing therapy is desirable. There are no previous studies evaluating montelukast's steroid-sparing effects in children with asthma. OBJECTIVE: To evaluate whether (1) montelukast as add-on therapy improves asthma symptom control and (2) montelukast provides steroid-sparing effects in children with asthma treated with low to moderate doses of ICS therapy. METHODS: In a double-blind, placebo-controlled trial, 36 children ages 6 to 14 years with symptomatic asthma maintained on a stable low to moderate dose of ICSs were randomly assigned to receive montelukast or matching placebo for 24 weeks after a run-in period of 2 weeks (period I). During the trial, subjects kept daily asthma diary cards and monthly spirometry was performed. After a 4 week add-on period (period II), the subjects completed a 20-week (period III) ICS tapering period based on a predetermined protocol. RESULTS: In period II, the difference in the number of rescue-free days was significantly higher in the montelukast group (P = 0.0001), and the number of rescue-free days per week was also significantly higher in montelukast-treated subjects compared with placebo subjects (P = 0.002). In period III, the percentage reduction in ICS dose was not significant between montelukast and placebo (P = 0.10), but the montelukast group experienced an average 17% decrease in ICS dose and the control group experienced an average 64% increase in ICS dose. CONCLUSIONS:Montelukast treatment significantly increased the number of rescue-free days in symptomatic children with asthma.
Authors: Haig Tcheurekdjian; Shannon M Thyne; L Keoki Williams; Marc Via; Jose R Rodriguez-Santana; William Rodriguez-Cintron; Pedro C Avila; Esteban González Burchard Journal: Ann Allergy Asthma Immunol Date: 2009-06 Impact factor: 6.347
Authors: Nina Kononowa; Sandra Michel; David Miedinger; Christiane E Pichler; Prashant N Chhajed; Arthur Helbling; Jörg D Leuppi Journal: J Drug Assess Date: 2013-04-02
Authors: Aniela I Pruteanu; Bhupendrasinh F Chauhan; Linjie Zhang; Sílvio O M Prietsch; Francine M Ducharme Journal: Cochrane Database Syst Rev Date: 2014-07-17