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NCT Number: NCT07426458

Ventilation and Perfusion in Asthmatics

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).

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Miami - Converge Miami

Miami, Florida, 33136, United States

Location status: Recruiting

Location contact

Tiffany Salcito

CONTACT

[email protected]

305-243-2568

Trishul Siddharthan, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Ventolin Hydrofluoroalkane (HFA)

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

Other names: AIRSUPRA

Primary outcomes

  1. Change in Regional Ventilation

    Time frame: Baseline, 30 minutes after budesonide administration

    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.

Secondary outcomes

  1. Change in Regional Mean Specific Perfusion

    Time frame: Baseline, 30 minutes after budesonide administration

    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.

  2. Percent Change in FEV₁ (Forced Expiratory Volume in 1 second)

    Time frame: Baseline, 60 minutes after budesonide administration

    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.

  3. Percent Change in FVC (Forced Vital Capacity)

    Time frame: Baseline, 60 minutes after budesonide administration

    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.

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

    Time frame: Baseline, 30 minutes after budesonide administration

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Maria McCoy

CONTACT

[email protected]

305-243-2568

Sonia Dipti Meena Velmurugan, MS

CONTACT

[email protected]

305-243-2568

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Australian Lung Health Initiative Pty Ltd

Registry information

Official study title

Ventilation and Perfusion in Individuals With Asthma

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 23, 2026
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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