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Impact of Metabolic Dysfunction and Mucus Plugging on Asthma Physiology

Active Not RecruitingN/A

Sponsor: University of California, San Francisco

Conditions: Asthma

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

1. Male or female ≥ 18 years old at Visit 0
2. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
3. History of physician diagnosed asthma
4. Evidence of bronchodilator reversibility (12% improvement in FEV1 after albuterol administration) or positive methacholine challenge PC20 or PD20. Historical evidence is accepted.
5. 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

Exclusion Criteria:

1. Asthma exacerbation or URI within the previous 6 weeks.
2. History of smoking

   1. If \<30 years old: Smoked for ≥5 pack-years
   2. If ≥30: Smoked for ≥10 pack years
3. Pregnancy
4. Absolute or relative contraindication to exercise testing per ATS criteria
5. Any other criteria that place the subject at unnecessary risk according to the judgment of the Principal Investigator and/or attending physician of record.

Locations (1)

San Francisco, California, United States