IL13 Signaling in Allergic Asthma

Launched by DUKE UNIVERSITY · Jul 26, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how a medication called dupilumab can help adults with asthma who also have obesity. The researchers want to understand how dupilumab affects certain cells in the airways of people with allergic and non-allergic asthma. They believe that this treatment might work differently depending on the type of asthma and the presence of obesity. By analyzing changes in gene and protein levels after treatment, the study aims to see if these changes relate to inflammation in the airways.

To participate in this trial, you need to be between 18 and 65 years old, have a body mass index (BMI) of 30 or higher, and have a doctor’s diagnosis of asthma. You should also be using certain asthma medications regularly. If you qualify, you will undergo tests and provide samples to help researchers learn more about how dupilumab works. It's important to note that this trial is not for everyone; for example, individuals with other serious lung diseases or those who have used certain asthma treatments recently may not be eligible. Overall, this study aims to find better ways to treat asthma in people who also have obesity.

Gender

ALL

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.