Management of Asthma in School age Children On Therapy (MASCOT): a randomised, double-blind, placebo-controlled, parallel study of efficacy and safety

• Published in: Health technology assessment (Winchester, England) England), 2013-02, Vol.17 (4), p.1-218
• Main Authors: Lenney, W, McKay, A J, Tudur Smith, C, Williamson, P R, James, M, Price, D
• Format: Article
• Language: English
• Subjects: Absenteeism; Acetates - administration & dosage; Acetates - adverse effects; Acetates - therapeutic use; Adolescent; Albuterol - administration & dosage; Albuterol - adverse effects; Albuterol - analogs & derivatives; Albuterol - therapeutic use; Androstadienes - administration & dosage; Androstadienes - adverse effects; Androstadienes - therapeutic use; Anti-Asthmatic Agents - administration & dosage; Anti-Asthmatic Agents - adverse effects; Anti-Asthmatic Agents - therapeutic use; asthma; Asthma - drug therapy; Bronchodilator Agents - administration & dosage; Bronchodilator Agents - adverse effects; Bronchodilator Agents - therapeutic use; Child; Cyclopropanes; Double-Blind Method; Drug Therapy, Combination; Female; Fluticasone; fluticasone propionate; Humans; low-dose inhaled corticosteroids; Male; montelukast; Quality of Life; Quinolines - administration & dosage; Quinolines - adverse effects; Quinolines - therapeutic use; randomised controlled trial; salmeterol; Salmeterol Xinafoate; Sulfides; United Kingdom
• ISSN: 1366-5278; 2046-4924
• DOI: 10.3310/hta17040

Asthma affects one in eight children in the UK. National management guidelines have been available for many years but, unlike in adults, studies in children have been few, with their methodologies often based on inappropriate adult models. Sound medical evidence in support of the national guidelines for asthma management in children is lacking. The MASCOT study has been developed to address this need. To determine whether adding salmeterol or montelukast to low-dose inhaled corticosteroids (ICSs) can reduce the number of exacerbations requiring treatment with oral corticosteroids in children with uncontrolled asthma. A randomised, double-blind, placebo-controlled trial with a 4-week run-in period on a fluticasone propionate inhaler (100 µg twice daily) with inhaler technique correction. Patients who met the post run-in period eligibility criteria were randomised in the ratio of 1 : 1 : 1 and were followed for 48 weeks. Secondary care hospitals based in England and Scotland with recruitment from primary and secondary care. Children aged 6-14 years with asthma requiring frequent short-acting beta-2 agonist relief, with symptoms of asthma resulting in nocturnal wakening and/or asthma that has interfered with usual activities. Three groups were compared: (1) inhaled fluticasone propionate 100 µg twice daily plus placebo tablet once daily; (2) inhaled fluticasone propionate 100 µg and salmeterol 50 µg twice daily (combination inhaler) plus placebo tablet once daily; and (3) inhaled fluticasone propionate 100 µg twice daily plus montelukast 5-mg tablet once daily. The primary outcome was the number of exacerbations requiring treatment with oral corticosteroids over 48 weeks. Secondary outcome measures included quality of life as measured by the Paediatric Asthma Quality of Life Questionnaire with Standardised Activities [PAQLQ(S)] and the Paediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ); time from randomisation to first exacerbation requiring treatment with a short course of oral corticosteroids; school attendance; hospital admissions; amount of rescue beta-2 agonist therapy prescribed; time from randomisation to treatment withdrawal (because of lack of efficacy or side effects); lung function at 48 weeks (as assessed by spirometry); cost-effectiveness; adverse events. The study was closed prematurely because of poor recruitment and the target sample size of 450 was not achieved. In total, 898 children were screened to enter the trial, 166 we