Results of the first study to evaluate use of the adult COPD drug in children age 5 years and younger lay fertile ground for future trials.
First Safety Assessment of Add-on Tiotropium in Pre-Schoolers. Children had persistent asthma inadequately controlled on ICSs; randomized to add-on once daily tiotropium 2.5 µg, tiotropium 5, or placebo.
Tiotropium Well-tolerated in Preschoolers. Adverse events were similar in both treatment groups and none led to discontinuation of treatment.
Fewer Exacerbations with Tiotropium. Tiotropium associated up to 63% decreased risk of exacerbations vs placebo.
No Difference in Worsening of Asthma Symptoms. Improvement from baseline in weekly worsening of asthma symptoms not significantly different from placebo.
Clinical Implications. Although safety profile of tiotropium was not formally statistically assessed, the safety outcomes in this trial were similar to those seen in patients age 6 to 17 years.
Results of the first study to evaluate use of tiotropium as add-on medication to inhaled corticosteroids in children age 5 years and younger found fewer asthma exacerbations vs placebo and similar effects on asthma improvement as placebo. Click through the short slide show above for highlights.Â Source: Vrijlandt EJLE, El Azzi G, Vandewalker M, et al. Safety and efficacy of tiotropium in children aged 1-5 years with persistent asthmatic symptoms: a randomised, double-blind, placebo-controlled trial. Lancet Respir Med. 2018 Jan 17. pii: S2213-2600(18)30012-2. doi: 10.1016/S2213-2600(18)30012-2.