Investigating IL13 Signaling in Allergic Asthma with Obesity

The Effects of Dupilumab on Asthma Outcomes and IL-13Rα2 Signaling in Airway Epithelial Cells in Allergic Asthma With Comorbid BMI ≥ 30

This study is testing how a medication called dupilumab affects airway cells in adults with allergic asthma and obesity compared to those with non-allergic asthma.

Quick facts

• Study type: Observational
• Enrollment: 54 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Duke University (Academic / other)
• Drugs / interventions: dupilumab
• Locations: 1 site (Durham, North Carolina)
• Trial ID: NCT05478824 on ClinicalTrials.gov

What this trial studies

This observational study aims to explore the effects of dupilumab on airway epithelial cells in adults with asthma and comorbid obesity. It will compare the transcriptomic and proteomic responses of nasal airway epithelial cells from patients with allergic asthma to those with non-allergic asthma. The study will enroll 32 participants, divided equally between the two groups, and will involve initial screening, skin allergy testing, and blood sampling to establish allergic status. The primary focus is to assess how dupilumab influences IL-13 receptor signaling and related gene expression in these patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with a BMI of 30 or higher, diagnosed with asthma, and either allergic or non-allergic asthma.

Not a fit: Patients without asthma or those with a BMI below 30 may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective treatments for obese patients suffering from allergic asthma.

How similar studies have performed: While the specific approach of this study is novel, previous studies have indicated that dupilumab can be effective in treating asthma, suggesting potential for success.

Eligibility criteria

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.

Where this trial is running

Durham, North Carolina

• Duke Asthma Allergy and Airway Center — Durham, North Carolina, United States (Recruiting)

Study contacts

• Principal investigator: Loretta Que, MD — Duke
• Study coordinator: Crc

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