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NCT05757583
Impact of Metabolic Dysfunction and Mucus Plugging on Asthma Physiology
Conditions: Asthma
Sex: All
Ages: 18 Years – N/A
Enrollment: 80
Sponsor: University of California, San Francisco
Location: United States
Summary
This is a single-center study of 80 subjects with asthma including those with obesity and metabolic dysfunction (MD), those with obesity and without metabolic dysfunction, those with severe asthma and mucus plugging and those with severe asthma and without mucus plugging.
Screening data will be reviewed to determine participant eligibility.
Participants who meet all inclusion criteria will participate in a cardiopulmonary exercise testing (CPET) visit to compare lung function markers and change in oxygen saturation between obese patients with and without MD and severe asthma patients with and without mucus plugging.
Eligibility Criteria
Inclusion Criteria:Male or female ≥ 18 years old at Visit 0Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.History of physician diagnosed asthmaEvidence of bronchodilator reversibility (12% improvement in FEV1 after albuterol administration) or positive methacholine challenge PC20 or PD20.
Historical evidence is accepted.Meets criteria for obesity or severe asthma a. Obesity: BMI≥30 i. Metabolic dysfunction is defined as presence of either:1. IL-6 high: Plasma IL-6 > 3.0 pg/mL 2. Insulin resistance: HOMA-IR > 3 mass units b.
Severe asthma: Requires treatment with high dose inhaled corticosteroids plus a second controller, systemic corticosteroid, or biologic therapy.i. Mucus Plugging is defined as mucus plug score ≥ 4Exclusion Criteria:Asthma exacerbation or URI within the previous 6 weeks.History of smokingIf <30 years old: Smoked for ≥5 pack-yearsIf ≥30: Smoked for ≥10 pack yearsPregnancyAbsolute or relative contraindication to exercise testing per ATS criteriaAny other criteria that place the subject at unnecessary risk according to the judgment of the Principal Investigator and/or attending physician of record.
Source: ClinicalTrials.gov (NCT05757583). StuddyBuddy aggregates publicly available trial information.