Examining how metabolic dysfunction and mucus plugging affect asthma
Impact of Metabolic Dysfunction and Mucus Plugging on Asthma Physiology
University of California, San Francisco · NCT05757583
This study is trying to see how obesity and mucus buildup affect breathing and exercise in people with severe asthma.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco (other) |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT05757583 on ClinicalTrials.gov |
What this trial studies
This observational study involves 80 subjects with asthma, focusing on those with obesity and metabolic dysfunction, as well as those with severe asthma and mucus plugging. Participants will undergo cardiopulmonary exercise testing to assess lung function markers and changes in oxygen saturation. The study aims to understand the mechanisms behind poor exercise tolerance in severe asthma patients by comparing dynamic hyperinflation and expiratory flow limitations among different patient groups. The findings could provide insights into how metabolic factors and mucus obstruction impact asthma physiology.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a history of asthma, particularly those who are obese or have severe asthma with mucus plugging.
Not a fit: Patients with recent asthma exacerbations or upper respiratory infections, as well as those with a significant smoking history, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of asthma in patients with obesity and metabolic dysfunction.
How similar studies have performed: While the specific combination of metabolic dysfunction and mucus plugging in asthma is less explored, related studies have shown promising results in understanding asthma physiology.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
San Francisco, California
- UCSF Airway Clinical Research Center — San Francisco, California, United States (RECRUITING)
Study contacts
- Principal investigator: John Fahy, MD, MS — University of California, San Francisco
- Study coordinator: Jade Vi, BS
- Email: jade.vi@ucsf.edu
- Phone: 415-476-1783
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Asthma