Impact of Metabolic Dysfunction and Mucus Plugging on Asthma Physiology
Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Male or female ≥ 18 years old at Visit 0
• Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
• History of physician diagnosed asthma
• Evidence 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 ≥ 4
Locations
United States
California
UCSF Airway Clinical Research Center
RECRUITING
San Francisco
Contact Information
Primary
Jade Vi, BS
jade.vi@ucsf.edu
415-476-1783
Backup
John Fahy, MD, MS
john.fahy@ucsf.edu
415-476-9940
Time Frame
Start Date:2023-04-05
Estimated Completion Date:2026-04
Participants
Target number of participants:80
Treatments
Patients with asthma, obesity and metabolic dysfunction
Otherwise healthy asthmatic subjects with:~1. Body Mass Index (BMI) ≥ 30; and~2. Metabolic dysfunction evidenced by at least one of the following:~ * high plasma IL-6 (\> 3.0 pg/mL)~ * insulin resistance (HOMA-IR \> 3 mass units)
Patients with asthma, obesity and no metabolic dysfunction
Otherwise healthy asthmatic subjects with:~1. Body Mass Index (BMI) ≥ 30; and~2. No evidence of metabolic dysfunction
Patients with severe asthma and mucus plugs
Otherwise healthy asthmatic subjects:~1. Requiring treatment with high dose inhaled corticosteroids plus a second controller, systemic corticosteroid, or biologic therapy; and~2. Evidence of mucus plugs as defined by a mucus plug score ≥ 4
Patients with severe asthma and no mucus plugs
Otherwise healthy asthmatic subjects:~1. Requiring treatment with high dose inhaled corticosteroids plus a second controller, systemic corticosteroid, or biologic therapy; and~2. No evidence of mucus plugs as defined by a mucus plug score \< 4