Montelukast vs Tiotropium Added to ICS in Children With Asthma

Photo by Navy Medicine / Unsplash

Indian journal of pediatrics Published May 1, 2026 Medically reviewed May 8, 2026 Study authors: Sengupta Soma, Das Rashmi Ranjan, Gulla Krishna Mohan, Kumar Ketan, Bal Shakti Kumar, Padhy Biswa Mo… PubMed ↗ DOI ↗ By Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

Key Takeaway

Consider that adding montelukast or tiotropium to ICS in children with asthma showed no significant difference in control at 3 months.

This randomized controlled trial included 152 children aged 6 to 14 years with partly controlled or uncontrolled asthma despite step 2 or 3 treatment per GINA 2021. Participants were randomized to receive either oral montelukast plus inhaled corticosteroids (ICS) or inhaled tiotropium plus ICS. The primary outcome was the proportion of children achieving an ACT or c-ACT score greater than 19 at 3 months.

At 3 months, 47 of 73 children (64.4%) in the montelukast group and 33 of 66 (50%) in the tiotropium group achieved the primary outcome. The difference was not statistically significant. The non-inferiority comparison of tiotropium to montelukast was inconclusive. Secondary outcomes at 3 or 6 months showed no significant differences between groups.

Regarding safety, one child in the montelukast group developed neuropsychiatric symptoms; no other significant adverse events were noted. Serious adverse events and discontinuations were not reported.

Key limitations include the inconclusive non-inferiority analysis and the lack of reported p-values or confidence intervals. The study was conducted at a single tertiary care center, which may limit generalizability.

For clinical practice, these findings suggest that both montelukast and tiotropium may be reasonable add-on options to ICS in children with asthma, but the evidence does not demonstrate superiority or non-inferiority of one over the other. Further research is needed to clarify comparative effectiveness.

Study Details

Study typeRct

Sample sizen = 152

EvidenceLevel 2

PublishedMay 2026

PMID41772161

View Original Abstract ↓

OBJECTIVES: To 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. METHODS: This 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. RESULTS: A 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. CONCLUSIONS: Non-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.