Ventilation and blood-flow patterns in adults with asthma
Ventilation and Perfusion in Individuals With Asthma
This trial will test whether inhaled corticosteroids and quick-acting albuterol change how air and blood move through the lungs of adults with asthma.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Miami Academic / other |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT07426458 on ClinicalTrials.gov |
What this trial studies
This Phase 4 interventional study uses radiographic imaging to measure regional ventilation (V-distribution), ventilation defect percentage (VDP), and ventilation heterogeneity (VH) in adult asthma patients. Participants are adults aged 18–75 with physician-diagnosed asthma, baseline FEV1 under 80% of predicted with ≥10% reversibility, and who have been on a stable inhaled corticosteroid dose for at least three months. The protocol acquires imaging around administration of fast-acting albuterol and an albuterol–budesonide intervention to detect regional changes in ventilation and perfusion. Major exclusions include current smokers or heavy past smokers, recent respiratory infection, very low lung function (FEV1 <50%), pregnancy or breastfeeding, and intolerance to the study medications.
Who should consider this trial
Good fit: Ideal candidates are adults 18–75 with physician-diagnosed asthma, baseline FEV1 <80% predicted with ≥10% reversibility after bronchodilator, and on a stable inhaled corticosteroid regimen for at least three months.
Not a fit: People with very severe obstruction (FEV1 <50%), current smokers or those with >10 pack-year history, recent respiratory infection, pregnancy or breastfeeding, intolerance to the study drugs, or recent use of systemic steroids or beta-blockers are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, the results could clarify how inhaled steroids and bronchodilators alter regional lung ventilation and perfusion, which may help tailor treatments for people with asthma.
How similar studies have performed: Previous imaging studies using regional ventilation measures and bronchodilator challenges have shown measurable changes, so the imaging approach has precedent though combining long-term ICS context with FABA responses may be less studied.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Miami, Florida
- University of Miami - Converge Miami — Miami, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Trishul Siddharthan, MD — University of Miami
- Study coordinator: Maria McCoy
- Email: mcm456@med.miami.edu
- Phone: 305-243-2568
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.