Efficacy and Safety of 2 Doses of Tiotropium Respimat® Compared to Placebo in Children With Severe Persistent Asthma

Summary

The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation solution (2.5 mcg and 5 mcg) delivered via Respimat® inhaler once daily in the evening over 12 weeks, compared to placebo, as add-on controller therapy on top of usual care in children (6 to 11 years old) with severe persistent asthma.

Timeline

Start

2012-07

Primary completion

2015-05

Completion

2015-05

Outcome

Mixed primary results

registry analysis (superiority or other test); Placebo Respimat vs Tio R2.5; p = 0.2724; Mean Difference (Net) 0.035 (95% CI -0.028 to 0.099); Mixed Models Analysis NCT01634152 ↗

registry analysis (superiority or other test); Placebo Respimat vs Tio R5; p <0.0001; Mean Difference (Net) 0.139 (95% CI 0.075 to 0.203); Mixed Models Analysis NCT01634152 ↗

Drugs

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

Indications