The overall aim of the study is to determine the clinical efficacy and mechanisms of action of anti-IL-4a (dupilumab) as treatment for patients with Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP) and Aspirin-Exacerbated Respiratory Disease (AERD).
The protocol involves an 8-week study of dupilumab in patients with CRSwNP and/or AERD. Participants will have 4 total doses of dupilumab administered, with each dose administered every 2 weeks. There will be full clinical assessments and biospecimen collections at Baseline (Visit 1), Week 2 (Visit 2), and Week 8 (Visit 3).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
8-week trial of dupilumab (an anti-IL-4a) in patients with AERD.
Brigham and Women's Hospital
Boston, Massachusetts, United States
Nasal fluid levels of LTE4
The nasal fluid levels of LTE4 will be measured at week 8 and will serve as a surrogate biomarker of respiratory mast cell activation or burden.
Time frame: At Week 8 (Visit 3)
Nasal fluid levels of albumin
The nasal fluid levels of albumin will be measured at week 8 and serve as a surrogate biomarker of nasal epithelial cell integrity.
Time frame: At Week 8 (Visit 3)
Sense of smell - University of Pennsylvania Smell Identification Test (UPSIT)
Patients' sense of smell will be assessed at week 8 using the UPSIT. The UPSIT scale goes from 0 to 40, with 0 being worse (no scents identified) and 40 being best (all scents identified)
Time frame: At Week 8 (Visit 3)
Rhinoscopic Total Polyp Score (TPS)
The extent of patients' nasal polyps will be assessed at week 8 using a TPS. The TPS scale goes from 0 (no polyps) to 8 (large polyps bilaterally), with 0 being best and 8 being worst.
Time frame: At Week 8 (Visit 3)
Peak Nasal Inspiratory Flow (PNIF)
Patients' nasal congestion will be assessed at week 8 by a PNIF. PNIF goes from 0 mL (no airflow) to 500 mL of airflow, with 0 being worst.
Time frame: At Week 8 (Visit 3)
Quality of life - 22-Item Sino-Nasal Outcome Test (SNOT-22)
Quality of life will be assessed at week 8 with a SNOT-22. For the SNOT-22, the scores range from 0 (no symptoms, excellent disease control) to 110 (maximum sinus symptoms, poor disease control).
Time frame: At Week 8 (Visit 3)
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Lung function - Forced Expiratory Volume 1 (FEV1)
Patients' lung function will be assessed at week 8 with an FEV1.
Time frame: At Week 8 (Visit 3)
Asthma control - Asthma Control Questionnaire-6 (ACQ-6)
Asthma control will be measured at week 8 with an ACQ-6. For the ACQ-6, scores ranging from 0 (well-controlled) to 6 (extremely poorly-controlled). A lower score indicates better asthma control.
Time frame: At Week 8 (Visit 3)
Number of treatment-related adverse events (AEs) and serious adverse events (SAEs) leading to study drug discontinuation
Safety will be measured by the number of treatment-related AEs and SAEs leading to dupilumab discontinuation.
Time frame: At Week 8 (Visit 3)