Asthma and obesity study probes Dupilumab's cellular effects
NCT ID NCT05478824
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at how the drug dupilumab changes gene and protein activity in airway cells from adults with asthma and obesity. Researchers compared allergic and non-allergic participants to understand different treatment responses. The goal was to gather knowledge, not to test a cure or symptom relief directly.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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28 people
The number who actually took part.
- Started
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Feb 2023
- Finished
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Nov 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Adult Asthmatics with or without allergy phenotype age 18 - 65 inclusive
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Duke Asthma Allergy and Airway Center
Durham, North Carolina, 27208, United States
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