Safety and efficacy of tiotropium in children aged 1 –5 years with persistent asthmatic symptoms: a randomised, double-blind, placebo-controlled trial

This study is registered with ClinicalTrials.gov (NCT01634113), and is completed. Findings Between July 26, 2012, and Dec 4, 2014, 102 children were randomly assigned to the three treatment groups (36 to receive tiotropium 2·5 μg, 32 to receive tiotropium 5 μg, and 34 to receive placebo). 101 children completed the study and were included in the analyses. The changes in adjusted weekly mean combined daytime asthma symptom scores between baseline and week 12 were not significantly different between any of the groups. The adjusted mean difference between the tiotropium 2·5 μg group and placebo group was −0·080 (95% CI −0·312 to 0·152) and the difference between tiotropium 5 μg and placebo group was −0·048 (−0·292 to 0·195). Adverse events were less frequent with tiotropium treatment than with placebo (20 [56%] of 36 children with tiotropium 2·5 μg, 18 [58%] of 31 with tiotropium 5 μg, and 25 [74%] of 34 with placebo), although no formal statistical comparison between groups was performed. A greater proportion of children reported asthma exacerbations as adverse events in the placebo group (ten [29%] of 34) than in the tiotropium groups (five [14%] of 36 in the 2·5 μg group and two [6%] of 31 in the 5 μg group). Serious adverse events were reported in three patients (all of whom received placebo); no adverse events led to discontinuation of treatment or death. Interpretation To our knowledge, our small study is the first to assess the safety and effic...
Source: The Lancet Respiratory Medicine - Category: Respiratory Medicine Source Type: research