Assess regional changes to perfusion and ventilation from inhaled corticosteroid (ICS) and Fast-acting beta-antagonist (FABA) among adult asthmatics using radiographically derived estimates of regional ventilation (V-distribution), ventilation defect percentage (VDP), and ventilation heterogeneity (VH).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Visit 1: Albuterol Sulfate (90mcg) two puffs will be administered via metered-dose inhaler (MDI) with spacer during the baseline study visit to obtain baseline imaging values.
Visit 2: AIRSUPRA (Albuterol/Budesonide) (90mcg/80mcg) two puffs will be administered via MDI with spacer during this study visit. This intervention is used to evaluate its effect on ventilation defect percentage (VDP), ventilation heterogeneity (VH), and perfusion metrics derived from XV LVAS imaging
University of Miami - Converge Miami
Miami, Florida, United States
RECRUITINGChange in Regional Ventilation
Regional ventilation will be measured using functional lung imaging (XV LVAS) before and after inhalation of Albuterol/Budesonide. The outcome will be defined as the change in voxel-wise ventilation distribution from end expiration to peak inspiration, normalized to regional lung volume.
Time frame: Baseline, 30 minutes after budesonide administration
Change in Regional Mean Specific Perfusion
Mean specific perfusion (MSP) will be measured using XV-LVAS-based flow maps derived from functional lung imaging. The reported value is a unitless regional perfusion ratio, calculated as Regional MSP divided by Total MSP. The outcome represents the change in this unitless metric between baseline imaging and follow-up imaging performed within 30 minutes after inhalation of budesonide.
Time frame: Baseline, 30 minutes after budesonide administration
Percent Change in FEV₁ (Forced Expiratory Volume in 1 second)
FEV₁ (Forced Expiratory Volume in 1 second) is the amount of air an individual can forcefully exhale in the first second of a maximal expiratory effort following a full inhalation. The FEV₁ will be measured before and after inhalation of Albuterol/Budesonide. The outcome is defined as the percent change in these values within the same visit, using standardized spirometry procedures.
Time frame: Baseline, 60 minutes after budesonide administration
Percent Change in FVC (Forced Vital Capacity)
FVC (Forced Vital Capacity) is the total volume of air that can be forcibly exhaled from the lungs after taking the deepest possible breath. The FVC, will be measured before and after inhalation of Albuterol/Budesonide. The outcome is defined as the percent change in these values within the same visit, using standardized spirometry procedures.
Time frame: Baseline, 60 minutes after budesonide administration
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Percent Change FEV₁/Forced Expiratory Volume (FVC) Ratio (Unitless)
The outcome is defined as the change in the percent ratio of Forced Expiratory Volume in 1 second (FEV₁) to Forced Vital Capacity (FVC) between the pre- and post-intervention assessments. The FEV₁/FVC ratio (unitless) will be measured using standardized spirometry immediately before and 30 minutes after inhalation of budesonide-formoterol during the same study visit
Time frame: Baseline, 30 minutes after budesonide administration