In young children with persistent asthmatic symptoms, tiotropium 2.5 µg or 5 µg was considered safe and may have the potential to reduce the risk for exacerbations but not symptoms, according to a study published in the Lancet Respiratory Medicine.
Researchers conducted an exploratory 12-week, double-blind, placebo-controlled, parallel-group, phase 2/3 regulatory multicenter international trial (ClinicalTrials.gov identifier: NCT01634113) in children aged 1 to 5 years with a least a 6-month history of persistent asthmatic symptoms and a need for inhaled corticosteroids.
The primary outcomes were safety and efficacy, as measured by the change in weekly mean combined daytime asthma symptom score from baseline to week 12.
Between July 26, 2012, and December 4, 2014, 102 children were randomly assigned to 1 of the 3 treatment groups — once-daily tiotropium 2.5 µg or 5 µg or placebo as add-on therapy to inhaled corticosteroids. A total of 101 children completed the study and were included in the analysis. Adverse events were less frequent with tiotropium than with placebo — 56% of those receiving the 2.5-µg dose of tiotropium, 58% of those receiving the 5-µg dose, and 74% of those on placebo experienced adverse events, but no formal statistical comparison among groups was performed.
The changes in adjusted weekly mean combined daytime asthma symptoms scores did not differ significantly among the groups. The adjusted mean difference between the tiotropium 2.5-µg group and the placebo group was –0.080 and the difference between the tiotropium 5-µg and the placebo group was –0.048.
In contrast, a greater proportion of children reported asthma exacerbations as adverse events in the placebo group (29%) than in the tiotropium groups (14% and 6% for the 2.5-µg and 5-µg groups, respectively).
The authors concluded that the tolerability of tiotropium is similar to that of placebo in young children, and while mean daytime asthma symptom scores were not improved with tiotropium, asthma exacerbation risk was reduced compared with placebo. However, larger trials are needed to further examine the efficacy and safety of tiotropium in young children with asthma.
Disclosures: Boehringer Ingelheim provided funding support for this study.
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 [published online January 16, 2018]. Lancet Respir Med. 2018. doi:10.1016/S2213-2600(18)30012-2