NCT05478824Completed
IL13 Signaling in Allergic Asthma
The Effects of Dupilumab on Asthma Outcomes and IL-13Rα2 Signaling in Airway Epithelial Cells in Allergic Asthma With Comorbid BMI ≥ 30
Source: ClinicalTrials.gov · Last updated 29 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 28 (actual)
- First submitted
- 26 Jul 2022
- Start date
- 21 Feb 2023
- Primary completion date
- 11 Nov 2025
- Lead sponsor
- Duke University
- NCT number
- NCT05478824
What you commit to
- Study type: Observational
- Participants enrolled: 28
- From 21 Feb 2023 to the primary completion date, 11 Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Smoking history \> 10 pack years or any cigarette use within the previous twelve months.
- Current use of dupilumab or other biologic therapy for asthma
- 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.
Other illness
- Lung disease other than asthma including chronic obstructive pulmonary disease (COPD) or emphysema, bronchiectasis, sarcoidosis, or interstitial lung fibrosis.
- Upper or lower respiratory tract infection within one month of the study.
- Positive COVID-19 test in last 3 months.
- 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.
Age
- Children \< 18 years of age.
Other
- Subjects with body mass index (BMI) \< 30 kg/m2.
- Pregnancy
- Untreated or uncontrolled sleep apnea.
- Recent active substance abuse (last 6 months).
- Near fatal asthma (intubation or intensive care unit (ICU) admission for asthma) within past 1 year.
Who the study is looking for
- 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:
- 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
- Negative skin prick test
- Absolute eosinophil count \< 150/uL
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Duke Asthma Allergy and Airway Center Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.