Ventilation and Perfusion in Asthmatics

NCT07426458 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 20251152
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in Regional Mean Specific Perfusion

  Baseline, 30 minutes after budesonide administration

• Percent Change in FEV₁ (Forced Expiratory Volume in 1 second)

  Baseline, 60 minutes after budesonide administration

• Percent Change in FVC (Forced Vital Capacity)

  Baseline, 60 minutes after budesonide administration

• Percent Change FEV₁/Forced Expiratory Volume (FVC) Ratio (Unitless)

  Baseline, 30 minutes after budesonide administration

Study Arms (1)

Albuterol Sulfate followed by AIRSUPRA (Albuterol/Budesonide)

EXPERIMENTAL

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; Drug: Albuterol-Budesonide

Interventions

Albuterol Sulfate DRUG

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.

Also known as: Ventolin Hydrofluoroalkane (HFA)

Albuterol Sulfate followed by AIRSUPRA (Albuterol/Budesonide)

Albuterol-Budesonide DRUG

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

Also known as: AIRSUPRA

Albuterol Sulfate followed by AIRSUPRA (Albuterol/Budesonide)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead
• Australian Lung Health Initiative Pty Ltd: collaborator

Study Sites (1)

University of Miami - Converge Miami

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Asthma

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Officials

• Trishul Siddharthan, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria McCoy

CONTACT

305-243-2568; mcm456@med.miami.edu

Sonia Dipti Meena Velmurugan, MS

CONTACT

305-243-2568; sxm3597@med.miami.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 23, 2026
• Study Start: April 27, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)