IL13 Signaling in Allergic Asthma

NCT05478824 | Completed

• 2 other identifiers: Pro00107990R668-AS-2198
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity; Asthma, Allergic; Asthma

Keywords

Asthma; Allergic Asthma; Non-Allergic Asthma; Adult; Obese; Obesity

Outcome Measures

Primary Outcomes (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.

  • Perform ex vivo assessments to determine if dupilumab induces significant differences in gene and protein expression in nasal airway epithelial cells derived from allergic and non-allergic asthma patients with obesity (body mass index (BMI) \>/= 30 kg/m2).

  7 days +/- 7 days

Secondary Outcomes (1)

• Determine the effect of dupilumab on expression and signaling activity of IL-4R, IL-13R1, and IL-13R2 in nasal airway epithelial cells isolated from patients with allergic vs. non-allergic asthma and comorbid obesity.

  7 days +/- 7 days

Study Arms (2)

Allergic Asthma

BMI ≥ 30 kg/m2

Non-allergic Asthma

BMI ≥ 30 kg/m2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult Asthmatics with or without allergy phenotype age 18 - 65 inclusive

You may qualify if:

• 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:
• i. Reversibility of at least 12% increase in forced expiratory volume in 1 sec (FEV1) 15-30 minutes after inhaling 2-4 puffs of albuterol or ii. Positive methacholine challenge defined as a 20% fall in FEV1 compared to baseline at less than 16 mg/ml.
• 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.
• Allergic Asthma Subjects
• Subjects with serum IgE \>100 IU/ml and
• Positive skin prick test
• Absolute eosinophil count \>150/uL or FeNO \>30 ppb (if on systemic steroid therapy)
• Non-allergic Asthma Subjects
• Subjects with serum IgE \<100 IU/ml and/or

You may not qualify if:

• Children \< 18 years of age.
• 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.
• Positive COVID-19 test in last 3 months.
• Untreated or uncontrolled sleep apnea.
• Recent active substance abuse (last 6 months).
• Current use of dupilumab or other biologic therapy for asthma
• Near fatal asthma (intubation or intensive care unit (ICU) admission for asthma) within past 1 year.
• Other major chronic illness in the opinion of the investigator that might interfere with the study; including, but not limited to, uncontrolled diabetes, uncontrolled HIV infection or other immune system disorder, seizure disorders, renal failure, liver disease, or unstable psychiatric illness.
• Participation in an intervention study (including non-pharmacologic interventions) or use of investigative drugs within the past 30 days or plans to enroll in such a trial during the study.

Sponsors & Collaborators

• Regeneron Pharmaceuticals: collaborator
• Duke University: lead

Study Sites (1)

Duke Asthma Allergy and Airway Center

Durham, North Carolina, 27208, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood, urine, tissue, and blood products

MeSH Terms

Conditions

Asthma; Obesity

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Loretta Que, MD

  Duke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: July 28, 2022
• Study Start: February 21, 2023
• Primary Completion: November 11, 2025
• Study Completion: November 11, 2025
• Last Updated: January 29, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)