NCT05757583 Impact of Metabolic Dysfunction and Mucus Plugging on Asthma Physiology
| NCT ID | NCT05757583 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Francisco |
| Condition | Asthma |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2023-04-05 |
| Primary Completion | 2026-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2023-04-05 with a primary completion date of 2026-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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: 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.
Contact & Investigator
John Fahy, MD, MS
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT05757583 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Asthma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05757583 currently recruiting?
Yes, NCT05757583 is actively recruiting participants. Contact the research team at jade.vi@ucsf.edu for enrollment information.
Where is the NCT05757583 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT05757583 clinical trial?
NCT05757583 is sponsored by University of California, San Francisco. The principal investigator is John Fahy, MD, MS at University of California, San Francisco. The trial plans to enroll 80 participants.
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