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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
31
University of Virginia - Fontaine Research Park
Charlottesville, Virginia, United States
Ventilation Heterogeneity Index (VHI)
VHI = lung defect volume divided by total lung volume. It is a ratio scale.
Time frame: Baseline
Change in Ventilation Heterogenity Index (VHI)
VHI = lung defect volume divided by total lung volume. This is a ratio scale that will be measured at four timepoints: enrollment (week 0), end of treatment 1(week 12), start of treatment 2 (week 16), and end of treatment 2 (week 24). The VHI will be compared at the beginning and end of phase 1 and at the beginning and end of phase two using ANOVA based on a mixed-effects model, with fixed effects of sequence, period, and treatment of a random effect of subject within sequence, and baseline covariate.
Time frame: Baseline (week 0), week 12, week 16, and week 24
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