AsthmaPhase 4NCT07426458
Ventilation and Perfusion in Asthmatics
A Phase 4 study testing Albuterol Sulfate and Albuterol-Budesonide in people with Asthma, run by University of Miami at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- Albuterol Sulfate and Albuterol-Budesonide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2026to Apr 2028
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami - Converge Miami
Miami, Florida, 33136
Tiffany Salcito, 305-243-2568, tns93@med.miami.edu
Trishul Siddharthan, MD
About this study
Official title: 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).
- Conditions
- Asthma
- Being tested
- Albuterol Sulfate, Albuterol-Budesonide
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albuterol SulfateDrug
Also called Ventolin Hydrofluoroalkane (HFA)
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.
Albuterol-BudesonideDrug
Also called AIRSUPRA
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Albuterol Sulfate; Drug: Albuterol-Budesonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 30 minutes after budesonide administration
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: Baseline, 60 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
Measured: Baseline, 30 minutes after budesonide administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start27 Apr 2026
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Australian Lung Health Initiative Pty Ltd
- Responsible party
- Principal investigator, Dipan Nishikant Karmali, University of Miami
- Investigators
- Trishul Siddharthan, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07426458
- Sponsor's protocol ID
- 20251152
- Status last verified
- Apr 2026
- First submitted
- 3 Feb 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No