Sinusitis
Conditions
Keywords
sinusitis, rhinitis, rhinosinusitis, chronic
Brief summary
The purpose of this study is to determine whether Reslizumab is effective for the treatment of chronic sinusitis.
Interventions
DRUGReslizumab
Reslizumab 3mg/kg intravenous (IV)
DRUGPlacebo
Matching Placebo intravenous (IV)
Sponsors
Joshua S. Jacobs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Written informed consent 2. Willingness and ability to comply with the requirements of the study 3. Female or male patients ages 18-75 at the time of screening 4. A diagnosis of chronic rhinosinusitis according to the clinical practice guideline (update) of the American academy of otolaryngology - head and neck surgery 5. Elevated blood eosinophils 6. Significant findings on computed tomography (CT) scan
Exclusion criteria
1. Unable to sign informed consent form 2. A woman that is pregnant or nursing a child 3. Known hypersensitivity to Reslizumab 4. Active cigarette smoking in the year prior to screening 5. Known underlying immunodeficiency 6. History of alcohol or drug abuse in the year prior to screening Other criteria may apply. Please contact the investigator for more information
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in computed tomography (CT) score | 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life questionnaire | 24 weeks |
| Smell test | 24 weeks |
| Endoscopy score | 24 weeks |
| Adverse events by body system | 24 weeks |
Countries
United States
Contacts
Primary ContactStudy Coordinator
Outcome results
None listed