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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventilation and Perfusion in Individuals With Asthma
- ClinicalTrials.gov ID
- NCT07426458
- Acronym / sponsor ID
- 20251152
- Conditions
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Australian Lung Health Initiative Pty Ltd
- Study start
- 27 Apr 2026 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Albuterol Sulfate followed by AIRSUPRA (Albuterol/Budesonide) | Experimental | Drug: Albuterol Sulfate, Drug: Albuterol-BudesonideAll 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Albuterol SulfateAlso: 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. | Drug | Albuterol Sulfate followed by AIRSUPRA (Albuterol/Budesonide) |
| Albuterol-BudesonideAlso: AIRSUPRAVisit 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 | Drug | Albuterol Sulfate followed by AIRSUPRA (Albuterol/Budesonide) |
Primary outcome
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.
4 secondary outcomes
Change in Regional Mean Specific Perfusion
Time frame: Baseline, 30 minutes after budesonide administration
Percent Change in FEV₁ (Forced Expiratory Volume in 1 second)
Time frame: Baseline, 60 minutes after budesonide administration
Percent Change in FVC (Forced Vital Capacity)
Time frame: Baseline, 60 minutes after budesonide administration
Percent Change FEV₁/Forced Expiratory Volume (FVC) Ratio (Unitless)
Time frame: Baseline, 30 minutes after budesonide administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trishul Siddharthan, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria McCoy (305-243-2568, mcm456@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Regional Ventilation (time frame: Baseline, 30 minutes after budesonide administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026; AzTrials last refreshed its copy on 29 Oct 2026.