None listed
Conditions
Brief summary
This is an open label prospective phase 2 clinical trial of 25 adult patients diagnosed with uncontrolled eosinophilic chronic rhinosinusitis (eCRS) with NP treated with Dupilumab for a 26 week plus a post-treatment visit at three months. At baseline and every 2 weeks patients will have a clinical assessment and complete a series of questionnaires. A blood sample and a nasal mucosal biopsy will be collected every 4 weeks. Protein and RNA analysis will be performed using the GeoMx™ DSP /CosMx™ single cell SMI platforms on tissue samples at baseline, week 4, week 12 and week 26. The objective of this study is to identify and assess the tissue histopathological changes in response to mepolizumab and/or dupilumab therapy in patients with nasal polyp eosinophilia.
Interventions
This is an open label prospective phase 2 clinical trial of 25 adult patients diagnosed with uncontrolled eosinophilic chronic rhinosinusitis (eCRS) with Nasal Polyps (NP) treated with Dupilumab for a 26 week plus a post-treatment visit at three months.
The Dupilumab treatment will consist of the following:
Dupilumab
• Trade name: Dupixent
• Dosage regimen: for chronic rhinosinusitis 300mg subcutaneous injection once every 2 weeks for 24 weeks.
• Participants will also undergo a blood test, e
This is an open label prospective phase 2 clinical trial of 25 adult patients diagnosed with uncontrolled eosinophilic chronic rhinosinusitis (eCRS) with Nasal Polyps (NP) treated with Dupilumab for a 26 week plus a post-treatment visit at three months. The Dupilumab treatment will consist of the following: Dupilumab • Trade name: Dupixent • Dosage regimen: for chronic rhinosinusitis 300mg subcutaneous injection once every 2 weeks for 24 weeks. • Participants will also undergo a blood test, endoscopy and FENO (fractional exhaled nitric oxide) test at each second visit (once per month). Adverse and serious adverse event recording will occur at each visit.
Sponsors
Griffith University
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Adult patients with nasal polyp eosinophilia whose condition is not fully managed by current standard of care • Not currently receiving Mepolizumab, Dupilumab or Benralizumab treatment • Patients who do not meet the PBS criteria for severe lower airway disease • Body weight: A minimum body weight >=40 kilograms (kg) at Visit 1 • Gender: Male or female. • Informed consent: Capable of giving signed written informed consent and willingness to participate to and comply with the study • Age over 18 Years
Exclusion criteria
• Subjects with known hypersensitivity to mepolizumab and/or dupilumab • Subjects with other conditions that could lead to elevated eosinophils such as Hypereosinophilic Syndromes, including Churg-Strauss Syndrome, or Eosinophilic Esophagitis. • Subjects with known immunodeficiency • Subjects with cystic fibrosis • Pregnant subjects or subjects currently lactating as the effect on human pregnancy is unknown.
Outcome results
None listed