drugset / Trial / NCT02577497

Effect of Extra- Fine Versus Coarse-Particle Inhaled Corticosteroids (ICS) on Ventilation Heterogeneity in Children With Poorly Controlled Asthma

NCT02577497

Phase 4 Completed 31 enrolled University of Virginia
RandomizedCrossoverSingle-blindTreatment

Summary

The primary objective of the study is to show that ventilation heterogeneity identified by hyperpolarized helium-3 lung MRI is prevalent children with poorly controlled asthma despite guidelines-based treatment with ICS. The secondary objective is to demonstrate whether or not eight weeks of treatment with extra-fine particle ICS (HFA-BDP) improves ventilation heterogeneity compared to treatment with a coarse particle ICS (fluticasone HFA or dry powder).

Timeline

Start
2016-06
Primary completion
2018-07-06
Completion
2018-07-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Beclomethasone Small molecule Inhaled
Subject Fluticasone Other / unclassified Inhaled

Indications