NCT07426458 · University of Miami
Ventilation and Perfusion in Asthmatics
What this study is about
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).
View original scientific description
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).
Interventions
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.
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
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Miami, Florida
Collaborators
Australian Lung Health Initiative Pty Ltd
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 5, 2026 · Source of record for eligibility and locations