Rashmi Ranjan Das¹, Soma Sengupta¹, Krishna Mohan Gulla¹, Biswa Mohan Padhy¹
1- AIIMS Bhubaneswar, India
Abstract Body
Introduction: In children with poorly controlled asthma, Montelukast is a common add-on drug to inhaled corticosteroids (ICS). Tiotropium has been tested in adults, however, no study has compared Tiotropium with Montelukast in children.
Objectives: To compare the efficacy and safety of ICS plus Montelukast with ICS plus Tiotropium inchildren (6-14 years age) with poorly controlled asthma (GINA 2022) at the end of 3 and 6 months, and to find whether Tiotropium is non-inferior to Montelukast.
Methods: In this open label parallel RCT, all the details (demography , clinical, spirometry , c- ACT/ACT score,quality of life (QoL) score, and adverse events) were recorded. The intervention arm received TiotropiumMDI (9 μg, OD), and the control arm Montelukast tablet (age appropriate dose, OD). The sample size was152 (non-inferiority margin of 10%).
Results: 152 children (Montelukast - 77 , Tiotropium - 75) were enrolled. The mean c-ACT/ACT score at 3months (primary outcome) was as follows: Montelukast group, 19.6 (95% CI: 18.87 to 20.51), and Tiotropium group, 18.32 (95% CI: 17 .8 to 19.45) (P = 0.064). The lower 95% CI of Tiotropium group did not cross the 10% non-inferiority margin (score of 17 .64). FEV1 improvement was greater with Montelukast at 3 months (P = 0.032), but was similar at 6 months (P = 0.09). QoL score, exacerbation frequency , rescue therapy , and systemic steroid use were comparable. One child in the Montelukast group developed neuro-psychiatric symptoms. No other significant adverse events were noted.
Conclusion: Tiotropium is non-inferior to Montelukast in children (6-14 years age) with poorly controlled asthma.