Status:
WITHDRAWN
Study of Chronic Rhinosinusitis Symptoms in Asthma Patients Undergoing Treatment With Reslizumab
Lead Sponsor:
University of Rochester
Conditions:
Chronic Rhinosinusitis (Diagnosis)
Asthma
Eligibility:
All Genders
18+ years
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 ...
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. St...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 14 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 19 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03369574
Start Date
November 14 2017
End Date
October 19 2018
Last Update
November 13 2019
Active Locations (1)
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1
University of Rochester Department of Otolaryngology Head and Neck Surgery
Rochester, New York, United States, 14642