Recruiting NCT07426458
Ventilation and Perfusion in Asthmatics
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Albuterol Sulfate, Albuterol-Budesonide.
- Who it may be relevant to
- Registry conditions: Asthma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Ventilation and Perfusion in Individuals With Asthma
Overview
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).
Interventions
- Drug 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. - Drug 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 measures
- Change in Regional Ventilation [Time frame: Baseline, 30 minutes after budesonide administration]
Secondary outcome measures (4)
- 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]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Miami - Converge Miami — Miami
Identifiers
NCT: NCT07426458 · 20251152