IL13 Signaling in Allergic Asthma
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:
🦠 Asthma, Allergic 🦠 Asthma 🦠 Obesity
🗓️ Study Start (Actual) 21 February 2023
🗓️ Primary Completion (Estimated) 31 August 2024
✅ Study Completion (Estimated) 31 August 2024
👥 Enrollment (Estimated) 54
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Durham, North Carolina, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Outpatient adults of either sex 18-65 years of age.
    • 2. Subjects with body mass index (BMI) ≥ 30 kg/m2.
    • 3. Physician diagnosis of asthma.
    • 4. 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.
    • 5. Negative urine pregnancy test in women of childbearing potential\* (confirmed during screening).
    • 6. 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
    • 7. Subjects with a smoking history \<10 pack years and no smoking in the last year.
    • 8. Willing and able to give informed consent and adhere to visit/protocol schedules.
    • Allergic Asthma Subjects
    • 1. Subjects with serum IgE \>100 IU/ml and
    • 2. Positive skin prick test
    • 3. Absolute eosinophil count \>150/uL or FeNO \>30 ppb (if on systemic steroid therapy)
    • Non-allergic Asthma Subjects
    • 1. Subjects with serum IgE \<100 IU/ml and/or
    • 2. Negative skin prick test
    • 3. Absolute eosinophil count \< 150/uL

    Exclusion Criteria:

    • 1. Children \< 18 years of age.
    • 2. Subjects with body mass index (BMI) \< 30 kg/m2.
    • 3. Pregnancy
    • 4. Lung disease other than asthma including chronic obstructive pulmonary disease (COPD) or emphysema, bronchiectasis, sarcoidosis, or interstitial lung fibrosis.
    • 5. Smoking history \> 10 pack years or any cigarette use within the previous twelve months.
    • 6. Upper or lower respiratory tract infection within one month of the study.
    • 7. Positive COVID-19 test in last 3 months.
    • 8. Untreated or uncontrolled sleep apnea.
    • 9. Recent active substance abuse (last 6 months).
    • 10. Current use of dupilumab or other biologic therapy for asthma
    • 11. Near fatal asthma (intubation or intensive care unit (ICU) admission for asthma) within past 1 year.
    • 12. 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.
    • 13. 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.
Ages Eligible for Study: 18 Years to 65 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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

  • First Submitted 26 July 2022
  • First Submitted that Met QC Criteria 26 July 2022
  • First Posted 28 July 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 8 November 2023
  • Last Update Posted 9 November 2023
  • Last Verified November 2023