Inhaled Corticosteroids Plus Tiotropium Compared to Inhaled Corticosteroids Plus Montelukast in Children with Partly Controlled/Uncontrolled Asthma: A Non-Inferiority Trial.

objectivesTo compare the efficacy and safety of oral montelukast and inhaled tiotropium as add-on drugs to inhaled corticosteroids (ICS) in children with partly controlled/uncontrolled asthma.

methodsThis open-label, parallel-group, non-inferiority, randomized controlled trial was conducted over two-year period in the pediatrics department of a tertiary care teaching institute. Children aged 6 to 14 y with partly controlled/uncontrolled asthma, despite being on step 2 or 3 of treatment as per Global Initiative for Asthma (GINA) 2021, were enrolled. The primary outcome was proportion of children with ACT/c-ACT score >19 at 3 mo. The secondary outcomes were proportion with ACT/c-ACT score >19 at 6 mo, change in lung function and quality of life score, asthma exacerbations, need for rescue therapy, and steroid use during the follow-up at 3 and 6 mo. All adverse events were recorded.

resultsA total of 152 participants were enrolled. At 3-mo follow up, 47/73 (64.4%) and 33/66 (50%) children in the montelukast and tiotropium arms respectively, had an Asthma Control Test/ Childhood Asthma Control Test (ACT/c-ACT) score >19. The difference was not statistically significant and the non-inferiority comparison of tiotropium to montelukast was inconclusive. There was no significant difference in any of the secondary outcomes at 3 or 6 mo. One child in the montelukast group developed neuropsychiatric symptoms. No other significant adverse events were noted.

conclusionsNon-inferiority of tiotropium to montelukast at 3 mo, when added to ICS in children with partly controlled/uncontrolled asthma, with respect to asthma control, was not proven in this trial. No significant difference was noted at 6 mo.