Efficacy of Intermittent Tiotropium in Early Childhood Wheezing

Summary

This study evaluates the effect of intermittent tiotropium bromide and salbutamol as needed versus intermittent fluticasone propionate and salbutamol as needed, or solely, salbutamol as needed on episode-free days in infants and toddlers with recurrent episodes of wheeze and/or shortness of breath.

Timeline

Start

2016-04-20

Primary completion

2020-11-18

Completion

2020-11-18

Outcome

Met primary endpoint

Stopped: “Subjects in the Salbutamol group discontinued the intervention more often due to troublesome respiratory symptoms”

registry analysis (superiority test); Tiotropium Bromide & Salbutamol vs Fluticasone Propionate & Salbutamol vs Salbutamol; p <0.01; Wilcoxon (Mann-Whitney); NCT03199976 ↗

Publications

• Kotaniemi-Syrjanen A, Klemola T, Koponen P, Jauhola O, Aito H, Malmstrom K, Malmberg LP, Rahiala E, Sarna S, Pelkonen AS, Makela MJ. Intermittent Tiotropium Bromide for Episodic Wheezing: A Randomized Trial. Pediatrics. 2022 Sep 1;150(3):e2021055860. doi: 10.1542/peds.2021-055860.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Fluticasone propionate	Other / unclassified	125 ug	Inhaled
Subject	Salbutamol	Unknown	0.2 mg	Inhaled
Subject	Tiotropium	Other / unclassified	5 ug	Inhaled

Indications