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NCT05757583Active, not recruiting

Impact of Metabolic Dysfunction and Mucus Plugging on Asthma Physiology

Source: ClinicalTrials.gov · Last updated 14 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
80 (estimated)
First submitted
23 Feb 2023
Start date
5 Apr 2023
Primary completion date
Jun 2027
Lead sponsor
University of California, San Francisco
Diseases
Asthma
NCT number
NCT05757583

What you commit to

  • Study type: Observational
  • Planned participants: 80
  • From 5 Apr 2023 to the primary completion date, Jun 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Asthma exacerbation or URI within the previous 6 weeks.

Age

  • History of smoking
    • If \<30 years old: Smoked for ≥5 pack-years
    • If ≥30: Smoked for ≥10 pack years

Other

  • 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.

Who the study is looking for

  • 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.
  • Mucus Plugging is defined as mucus plug score ≥ 4

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
UCSF Airway Clinical Research Center
Coordinator of this site? Confirm its status
San FranciscoUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.