RECRUITING

Impact of Metabolic Dysfunction and Mucus Plugging on Asthma Physiology

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Conditions

Asthma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Impact of Metabolic Dysfunction and Mucus Plugging on Asthma Physiology

Quick Facts

Study Start:2023-04-05
Study Completion:2025-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05757583

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male or female ≥ 18 years old at Visit 0
  2. 2. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
  3. 3. History of physician diagnosed asthma
  4. 4. Evidence of bronchodilator reversibility (12% improvement in FEV1 after albuterol administration) or positive methacholine challenge PC20 or PD20. Historical evidence is accepted.
  5. 5. Meets criteria for obesity or severe asthma a. Obesity: BMI≥30 i. Metabolic dysfunction is defined as presence of either:
  6. 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.
  1. 1. Asthma exacerbation or URI within the previous 6 weeks.
  2. 2. History of smoking
  3. 1. If \<30 years old: Smoked for ≥5 pack-years
  4. 2. If ≥30: Smoked for ≥10 pack years
  5. 3. Pregnancy
  6. 4. Absolute or relative contraindication to exercise testing per ATS criteria
  7. 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.

Contacts and Locations

Study Contact

Xavier Orain, BS
CONTACT
415-502-3472
xavier.orain@ucsf.edu
John Fahy, MD, MS
CONTACT
415-476-9940
john.fahy@ucsf.edu

Principal Investigator

John Fahy, MD, MS
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

UCSF Airway Clinical Research Center
San Francisco, California, 94143
United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

  • John Fahy, MD, MS, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-05
Study Completion Date2025-04

Study Record Updates

Study Start Date2023-04-05
Study Completion Date2025-04

Terms related to this study

Additional Relevant MeSH Terms

  • Asthma