Clinical trial NCT03369574: Study of Chronic Rhinosinusitis Symptoms in Asthma Patients Undergoing Treatment With Reslizumab
Official title: Prospective Observational Study of Chronic Rhinosinusitis Symptoms in Asthma Patients Undergoing Treatment With Reslizumab
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Chronic Rhinosinusitis (Diagnosis)
Asthma
Nasal Polyps
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2017-12-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with poorly controlled moderate to severe asthma with eosinophilia and a diagnosis of chronic rhinosinusitis with nasal polyposis

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean Sino-Nasal Outcome Test (SNOT)-22 Score
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Department of Otolaryngology Head and Neck Surgery
state: New York
Study officials:
affiliation: University of Rochester
name: Li-Xing Man, MSc, MD, MPA
role: PRINCIPAL_INVESTIGATOR
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