COMPLETED

IL13 Signaling in Allergic Asthma

Conditions

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

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-02-21

Study Completion:2025-11-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05478824

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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: 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. 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) 1. Subjects with serum IgE \<100 IU/ml and/or 2. Negative skin prick test 3. Absolute eosinophil count \< 150/uL	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.

Inclusion Criteria

Exclusion 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:
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.
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)
1. Subjects with serum IgE \<100 IU/ml and/or
2. Negative skin prick test
3. Absolute eosinophil count \< 150/uL

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.

Contacts and Locations

Principal Investigator

Loretta Que, MD

PRINCIPAL_INVESTIGATOR

Duke

Study Locations (Sites)

Duke Asthma Allergy and Airway Center

Durham, North Carolina, 27208

United States

Collaborators and Investigators

Sponsor: Duke University

Loretta Que, MD, PRINCIPAL_INVESTIGATOR, Duke

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

Study Start Date2023-02-21

Study Completion Date2025-11-11

Study Record Updates

Study Start Date2023-02-21

Study Completion Date2025-11-11

Terms related to this study

Keywords Provided by Researchers

Asthma
Allergic Asthma
Non-Allergic Asthma
Adult
Obese
Obesity

Additional Relevant MeSH Terms

Asthma, Allergic
Asthma
Obesity