A Study to Evaluate Efficacy and Safety of Tiotropium in Children 6 to 11 Years Old With Moderate Asthma

Phase 2 Completed 101 enrolled Boehringer Ingelheim Pfizer · collab

RandomizedCrossoverQuadruple-blindTreatment

Summary

The aim of this trial is to select an optimum dose may be selected based on bronchodilator efficacy, safety evaluations and pharmacokinetics of tiotropium bromide.

Timeline

Start: 2011-08
Primary completion: 2012-09
Completion: 2012-09

Outcome

Met primary endpoint

registry Placebo vs Tio R5; p = 0.0002; Mean Difference (Final Values) 0.087 (95% CI 0.042 to 0.132) NCT01383499 ↗

paper 5 μg (272 mL), 2.5 μg (290 mL) and 1.25 μg (261 mL) were significantly greater than with placebo Respimat® (185 mL; PMID 25851298 ↗

Publications

Vogelberg C, Moroni-Zentgraf P, Leonaviciute-Klimantaviciene M, Sigmund R, Hamelmann E, Engel M, Szefler S. A randomised dose-ranging study of tiotropium Respimat(R) in children with symptomatic asthma despite inhaled corticosteroids. Respir Res. 2015 Feb 7;16(1):20. doi: 10.1186/s12931-015-0175-9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tiotropium	Other / unclassified	1.25 ug	Inhaled
Subject	Tiotropium	Other / unclassified	2.5 ug	Inhaled
Subject	Tiotropium	Other / unclassified	5 ug	Inhaled