Albuterol + Budesonide for Asthma

Overseen By Sonia Dipti Meena Velmurugan, MS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Miami

Must be taking: Inhaled corticosteroids

Must not be taking: Beta-blockers, Systemic glucocorticosteroids

Disqualifiers: Smoking, Pregnancy, Respiratory infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 2

Duration: 2 visits

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Who Is on the Research Team?

Trishul Siddharthan, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

Inclusion Criteria

I am between 18 and 75 years old.

I have used inhaled corticosteroids regularly for at least 3 months.

I have been diagnosed with asthma by my doctor.

Exclusion Criteria

Current nicotine vaping

Pregnant and breast-feeding women

Inhaled corticosteroids (ICS)/fast-acting beta agonist (FABA) intolerance

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants will inhale Albuterol Sulfate followed by AIRSUPRA (Albuterol/Budesonide) via metered-dose inhaler (MDI) with spacer

2 visits

2 visits (in-person)

Follow-up

Participants are monitored for changes in regional ventilation and perfusion using functional lung imaging

30-60 minutes after treatment

What Are the Treatments Tested in This Trial?

Interventions

• Albuterol-Budesonide
• Albuterol Sulfate

How Is the Trial Designed?

Group I: Albuterol Sulfate followed by AIRSUPRA (Albuterol/Budesonide) Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Australian Lung Health Initiative Pty Ltd

Collaborator