drugset / Trial / NCT01634152

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

NCT01634152

Phase 3 Completed 401 enrolled Boehringer Ingelheim Pfizer · collab
RandomizedParallel-groupDouble-blindTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Tiotropium Other / unclassified 2.5 ug Inhaled
Subject Tiotropium Other / unclassified 5 ug Inhaled

Indications