Ventilation and Perfusion in Asthmatics

Ventilation and Perfusion in Individuals With Asthma

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 Overview

• Status: Recruiting
• Conditions: Asthma
• Intervention / Treatment: Drug: Albuterol Sulfate; Drug: Albuterol-Budesonide

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Maria McCoy; Phone Number: 305-243-2568; Email: mcm456@med.miami.edu
• Study Contact Backup: Name: Sonia Dipti Meena Velmurugan, MS; Phone Number: 305-243-2568; Email: sxm3597@med.miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami - Converge Miami
      • Principal Investigator: Trishul Siddharthan, MD
      • Contact: Tiffany Salcito; Phone Number: 305-243-2568; Email: tns93@med.miami.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Physician diagnosis of asthma
• Baseline Forced Expiratory Volume in 1 Second (FEV1) < 80% of predicted, with reversibility (10%) on post-bronchodilator spirometry
• Adults, 18-75 years of age
• Long-term inhaled controller medication consisting of or including an Inhaled corticosteroids (ICS) at a steady dose for at least 3 months before enrollment

Exclusion Criteria:

• Current cigarette smoking or a past history of >10 pack-year smoking
• Current nicotine vaping
• Pregnant and breast-feeding women
• Respiratory infection within 4 weeks of proposed study date
• Forced Expiratory Volume in 1 Second (FEV1) < 50%
• Inhaled corticosteroids (ICS)/fast-acting beta agonist (FABA) intolerance
• Use of beta-blockers
• Use of systemic glucocorticosteroids or oral methyl-xanthines within 30 days of planned study visit.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Albuterol Sulfate followed by AIRSUPRA (Albuterol/Budesonide); All participants in this single-arm study will complete 2 study visits, each lasting approximately 1 hour. Interventions will be administered in a sequential order.; Visit 1: Participants will inhale Albuterol Sulfate via metered-dose inhaler (MDI) with spacer; Visit 2: Participants will inhale AIRSUPRA (Albuterol/Budesonide) via metered-dose inhaler (MDI) with spacer as the second stage of treatment.

Drug: Albuterol Sulfate; 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.; Other Names: Ventolin Hydrofluoroalkane (HFA); Drug: Albuterol-Budesonide; 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; Other Names: AIRSUPRA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change 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.	Baseline, 30 minutes after budesonide administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 30 minutes after budesonide administration
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	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.	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.	Baseline, 60 minutes after budesonide administration

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: Australian Lung Health Initiative Pty Ltd
• Investigators: Principal Investigator: Trishul Siddharthan, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: February 3, 2026
• First Submitted That Met QC Criteria: February 20, 2026
• First Posted (Actual): February 23, 2026

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma; Organic Chemicals; Amines; Alcohols; Amino Alcohols; Ethanolamines; Phenethylamines; Ethylamines; Albuterol
• Other Study ID Numbers: 20251152

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No