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



Status:Recruiting
Conditions:Asthma, Sinusitis
Therapuetic Areas:Otolaryngology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:4/22/2018
Start Date:July 1, 2018
End Date:January 1, 2020
Contact:Paul Allen, PhD
Email:Paul_Allen@URMC.Rochester.edu
Phone:5852765181

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

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.

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.

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
We found this trial at
1
site
Rochester, New York 14642
Principal Investigator: Li-Xing Man, MSc, MD, MPA
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mi
from
Rochester, NY
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