RCT Abstract - Budesonide-formoterol versus salbutamol as reliever therapy in children with mild asthma (CARE): a 52-week, open-label, multicentre, superiority, randomised controlled trial

Le résumé fourni par la source

Background: Combination inhaled corticosteroid (ICS)-formoterol reliever monotherapy reduces the rate of asthma attacks compared to short-acting beta2-agonist (SABA) reliever monotherapy in adults. Its comparative efficacy in children has not been established. Methods: A 52-week, open-label, parallel-group, multicentre, superiority, randomised controlled trial in children aged five to 15 years with asthma using SABA reliever monotherapy was undertaken at 15 clinical trials sites in New Zealand. Participants were randomised 1:1 to either budesonide-formoterol 50/3μg, two actuations as needed, or salbutamol 100μg, two actuations as needed. The primary outcome was asthma attacks as rate per participant per year. Secondary outcomes included the rate of severe asthma attacks, growth velocity, asthma control (Asthma Control Questionnaire, symptom-only version [ACQ-5]), spirometry (Forced Expiratory Volume in 1 second, percentage predicted [FEV1%]) and fractional exhaled nitric oxide (FENO). Trial registration: ACTRN12620001091998. Findings: 360 participants were assigned to treatment (179 in the budesonide-formoterol group and 181 in the salbutamol group). The annualised rate of asthma attacks was lower in the budesonide-formoterol group than in the salbutamol group, cluster-adjusted rates 0·23 versus 0·41 per participant per year, relative rate (95% CI) 0·55 (0·35 to 0·86), p=0·012. The relative rate of severe attacks was 0·60 (0·32 to 1·14); receipt of any systemic corticosteroid, odds ratio 0.53 (0.27 to 1.06); growth velocity, mean difference -0·35cm (-0·93 to 0·24); ACQ-5, mean difference -0·003 (-0·12 to 0·11); FEV1%, mean difference 0·36% (-2·46 to 3·17); and FENO, ratio geometric means 0·98 (0·86 to 1·11). The number of participants with at least one adverse event was 162 (91%) and 167 (92%) in the budesonide-formoterol and salbutamol groups respectively, odds ratio 0·79 (0·35 to 1·79). Interpretation: In children aged five to 15 years with mild asthma, budesonide-formoterol reliever monotherapy is superior to salbutamol for preventing asthma attacks with a similar safety profile.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.