drugset / Trial / NCT01634139

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

NCT01634139

Phase 3 Completed 403 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 delivered via Respimat® inhaler (2.5 mcg and 5 mcg once daily in the evening) over 48 weeks, compared to placebo, in children (6 to 11 years old) with moderate persistent asthma.

Timeline

Start
2012-07
Primary completion
2015-06
Completion
2015-12

Drugs

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

Indications