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| Name | Class |
|---|---|
| Australian Lung Health Initiative Pty Ltd | UNKNOWN |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albuterol Sulfate | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 30 minutes after budesonide administration |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria McCoy | Contact | 305-243-2568 | mcm456@med.miami.edu | |
| Sonia Dipti Meena Velmurugan, MS | Contact | 305-243-2568 | sxm3597@med.miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Trishul Siddharthan, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami - Converge Miami | Recruiting | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000420 | Albuterol |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Albuterol-Budesonide | Drug | 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 |
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| 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. | 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. | 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 | Baseline, 30 minutes after budesonide administration |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000588 |
| Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |