NCT05478824Befejeződött
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. jan. 29.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 28 (tényleges)
- Első benyújtás
- 2022. júl. 26.
- Kezdés
- 2023. febr. 21.
- Elsődleges befejezés
- 2025. nov. 11.
- Fő szponzor
- Duke University
- NCT-szám
- NCT05478824
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Bevont résztvevők: 28
- 2023. febr. 21. és az elsődleges befejezés (2025. nov. 11.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- 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.
Más betegség
- 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.
Életkor
- Children < 18 years of age.
Egyéb
- 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.
Kiket keres a vizsgálat
- 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
Életkor a regiszterben: 18 év – 65 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Duke Asthma Allergy and Airway Center | Durham | Egyesült Államok | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.