Asthma, Chronic Rhinosinusitis (Diagnosis), Nasal Polyps
Conditions
Brief summary
The primary objective of this research is to monitor chronic rhinosinusitis (CRS) symptoms in asthma patients who are undergoing treatment with reslizumab. A secondary objective is to explore whether there are sub-populations that appear to benefit or not benefit from reslizumab in terms of their CRS symptoms.
Detailed description
This is a prospective observational study of patients receiving reslizumab to treat their asthma. Some asthma patients receiving reslizumab also have CRS, which might also be improved by this drug. Study measures will be obtained from the medical records of eligible subjects who consent to participate. The study has no specific procedures per se, because all study measures are acquired during the course of standard of care treatment and will be abstracted from those medical records.
Interventions
DRUGReslizumab
reslizumab administration
Sponsors
University of Rochester
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age is 18 years or older * Physician diagnosis of poorly controlled moderate to severe asthma despite typical medical therapy with an eosinophilic phenotype (defined by blood eosinophil count of 150 µL or greater within 6 weeks of enrollment) * Initiating or undergoing reslizumab therapy (Reslizumab - Patient Information listed in Appendix 1 for reference) * Physician diagnosis of chronic rhinosinusitis with nasal polyposis * Able to understand and willing to provide informed consent * Able to complete standard of care English-language questionnaires
Exclusion criteria
* Current smokers * Significant uncontrolled medical conditions * Ongoing malignancy or history of cancer in remission for less than 12 months * Subjects who had received immunosuppressive medications within 3 months of enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Sino-Nasal Outcome Test (SNOT)-22 Score | 1 year | SNOT-22 score ranges from 0 to 110 with higher scores indicating worse symptoms. The questionnaire consists of 22 questions regarding common sinonasal complaints of patients with chronic sinus disease, each question graded 0 to 5 (0 No Problem, 1 Very Mild Problem, 2 Mild or Slight Problem, 3 Moderate Problem, 4 Severe Problem, 5 Problem as Bad as it Can Be). |
Countries
United States
Outcome results
None listed