Impact of Metabolic Dysfunction and Mucus Plugging on Asthma Physiology

Running, not enrolling

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT05757583

Run by

University of California, San Francisco

People needed

80

Starts

2023-04-05

Expected to finish

2027-06-01

Last updated by the study team

2026-07-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• 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

You may not qualify if…

• Asthma exacerbation or URI within the previous 6 weeks.
• History of smoking
• If <30 years old: Smoked for ≥5 pack-years
• If ≥30: Smoked for ≥10 pack years
• Pregnancy
• Absolute or relative contraindication to exercise testing per ATS criteria
• Any other criteria that place the subject at unnecessary risk according to the judgment of the Principal Investigator and/or attending physician of record.

Where it is running

• UCSF Airway Clinical Research Center — San Francisco, California, United States

Full record on ClinicalTrials.gov

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