Recruiting

ICS & FABA

Sponsor:

University of Miami

Code:

NCT07426458

Conditions

Asthma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Albuterol Sulfate

Albuterol-Budesonide

Study Details

Brief 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).

Conditions

Asthma

Study ID

NCT07426458

Start date

Apr 27, 2026

Status verified date

Apr, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Albuterol Sulfate followed by AIRSUPRA (Albuterol/Budesonide)

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.

Interventions

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.

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 measure

  • Change in Regional Ventilation [ Time Frame: Baseline, 30 minutes after budesonide administration ]

Central Contacts and Locations

Central contacts

Maria McCoy

305-243-2568mcm456@med.miami.edu

Sonia Dipti Meena Velmurugan, MS

305-243-2568sxm3597@med.miami.edu

Locations

University of Miami - Converge Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Tiffany Salcito

305-243-2568tns93@med.miami.edu

Principal Investigator:

Trishul Siddharthan, MD

More Information

Sponsor

University of Miami

Last update posted

May 5, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-05-05.