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Asthma affects one in eight children in the UK but there were few studies carried out to inform the national guidelines for asthma management in children. The MASCOT study was developed to address this need.
MASCOT aimed to determine whether adding salmeterol or montelukast to a low-dose inhaled corticosteroids (fluticasone propionate) would reduce the number of asthma flare ups (exacerbations) needing treatment with oral steroids in children with uncontrolled asthma.
The MASCOT treatment arms were (1) inhaled fluticasone propionate twice daily plus placebo tablet once daily; (2) Combination inhaler of fluticasone propionate and salmeterol twice daily plus placebo tablet once daily; and (3) inhaled fluticasone propionate twice daily plus montelukast 5-mg tablet once daily.
MASCOT had a 4-week run-in period when all children were treated with a fluticasone propionate inhaler and those who continued to meet the post run-in eligibility were entered onto the study had an equal chance of receiving any one of the study treatment. Study treatment and follow up was then for 48 weeks.
MASCOT Closed prematurely because of poor recruitment. 898 children were screened to enter the trial, 166 were registered for the 4-week run-in period and 63 were randomised (group 1: 19, group 2: 23, group 3: 21), with 38 contributing data for the primary outcome analysis. There were no significant differences between groups for any of the outcomes. Adverse events were similar between the groups except for nervous system disorders, which were more frequently reported on fluticasone plus montelukast.
Based on the results of the MASCOT study it is not possible to conclude whether adding salmeterol or montelukast to ICSs can reduce the number of exacerbations requiring treatment with oral corticosteroids in children with uncontrolled asthma.
- Lenney W, McKay AJ, Tudur Smith C, Williamson PR, James M, Price D, on behalf of the MASCOT Study Group. Management of Asthma in School age Children On Therapy (MASCOT) (2013). A randomised, double-blind, placebo-controlled, parallel study of efficacy and safety. Health Technol Assess 17(4)