drugset / Trial / NCT02150499

A Study of Levalbuterol Tartrate HFA Inhalation Aerosol Metered Dose Inhaler (MDI) in Pediatric Subjects

NCT02150499 ↗

Phase 3 Terminated 18 enrolled Sumitomo Pharma America, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a study of levalbuterol tartrate HFA inhalation aerosol MDI in pediatric subjects birth to ≤ 48 months of age who go to the Emergency Department (ED) or their physician's office with an acute bronchospasm. Subjects presenting to the ED or physician's office with an acute bronchospasm must have a history of reactive airways disease, based on subjects' parent/guardian report.

Timeline

Start
2014-07
Primary completion
2014-12
Completion
2014-12

Drugs

EvaluationDrugModalityDoseRoute
Subject levalbuterol tartrate HFA inhalation aerosol Unknown 180 ug Inhaled
Subject levalbuterol tartrate HFA inhalation aerosol Unknown 360 ug Inhaled

Indications