Study of Chronic Rhinosinusitis Symptoms in Asthma Patients Undergoing Treatment With Reslizumab

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective Observational Study of Chronic Rhinosinusitis Symptoms in Asthma Patients Undergoing Treatment With Reslizumab

Conditions
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Chronic Rhinosinusitis (Diagnosis), Asthma, Nasal Polyps

Intervention / Treatment
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* Drug: Reslizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| chronic rhinosinusitis and eosinophilic asthma<br>Adults over the age of 18, diagnosed with poorly controlled moderate to severe asthma with an eosinophilic phenotype (defined by blood eosinophil count of 150 µL or greater within 6 weeks of enrollment) who are initiating/undergoing reslizumab therapy and also carry a physician diagnosis of chronic rhinosinusitis with nasal polyposis | Drug: Reslizumab<br>* reslizumab administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Sino-Nasal Outcome Test (SNOT)-22 Score | 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). | 1 year |