IL13 Signaling in Allergic Asthma (NCT05478824) | Clinical Trial Compass
CompletedNot Applicable
IL13 Signaling in Allergic Asthma
United States28 participantsStarted 2023-02-21
Plain-language summary
This study will investigate the role of dupilumab in the treatment of asthma with comorbid obesity. It is hypothesized that in airway epithelial cells, unique transcriptomic and proteomic expression patterns distinguish allergic and non-allergic patients with asthma and obesity and drive significant differential responses to dupilumab. It is further hypothesized that dupilumab will increase interleukin-13 receptor alpha 2 (IL-13Rα2) levels and/or signaling activity on airway epithelial cells isolated from allergic asthma patients with obesity. This is a pre-clinical research study of dupilumab-induced gene and protein expression analyses in nasal airway epithelial cells of adults with asthma and comorbid obesity. The study primarily seeks to: 1) assess the effect of dupilumab on transcriptomes, phosphoproteomes and secretomes of well-differentiated, primary airway epithelial cells as a function IL-13R subunit expression and IL-13Ra2 signaling, in allergic and non-allergic asthma patients with obesity; and 2) test whether dupilumab-induced gene and protein changes significantly correlate with parameters of airway inflammation in allergic and non-allergic asthma.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Outpatient adults of either sex 18-65 years of age.
✓. Subjects with body mass index (BMI) ≥ 30 kg/m2.
✓. Physician diagnosis of asthma.
✓. Documented history of either bronchodilator reversibility or positive methacholine challenge in past 2 years:
✓. Negative urine pregnancy test in women of childbearing potential\* (confirmed during screening).
✓. Regular treatment with inhaled corticosteroid (ICS) and long-acting beta agonist (LABA) combination medication for at least 3 months; on a stable dose for the 4 weeks prior to Visit 1
✓. Subjects with a smoking history \<10 pack years and no smoking in the last year.
✓. Willing and able to give informed consent and adhere to visit/protocol schedules.
Exclusion criteria
✕. Children \< 18 years of age.
What they're measuring
1
Critically assess dupilumab-regulated transcriptome, phosphoproteome and secretome of nasal airway epithelial cells isolated from patients with allergic vs. non-allergic asthma and comorbid obesity.
. Subjects with body mass index (BMI) \< 30 kg/m2.
✕. Pregnancy
✕. Lung disease other than asthma including chronic obstructive pulmonary disease (COPD) or emphysema, bronchiectasis, sarcoidosis, or interstitial lung fibrosis.
✕. Smoking history \> 10 pack years or any cigarette use within the previous twelve months.
✕. Upper or lower respiratory tract infection within one month of the study.