Impact of Metabolic Dysfunction and Mucus Plugging on Asthma Physiology

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT05757583
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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 Dates

Start date
Apr 5, 2023
Status verified
Jul 2025
Primary completion
Apr 30, 2026
Completion
Apr 30, 2026

Study Design

Enrollment
80 participants (estimated)

Arms

  • Arm: 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)
  • Arm: 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
  • Arm: 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
  • Arm: 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

Primary Outcome Measure

Change in EELV (End Expiratory Lung Volume) [ Time Frame: At CPET visit. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UCSF Airway Clinical Research CenterSan FranciscoCalifornia94143
Jade Vi, BS
[email protected]
415-476-1783
John Fahy, MD, MS
[email protected]
415-476-9940
John Fahy, MD, MS (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Francisco, CA

By condition
Asthma
By specialty
PulmonologyLung disease
By research site
UCSF Airway Clinical Research Center· San Francisco, CA

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