Asthma Clinical Trial
Official title:
Prospective Observational Study of Chronic Rhinosinusitis Symptoms in Asthma Patients Undergoing Treatment With Reslizumab
Verified date | November 2019 |
Source | University of Rochester |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | October 19, 2018 |
Est. primary completion date | October 19, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Rochester Department of Otolaryngology Head and Neck Surgery | Rochester | New York |
Lead Sponsor | Collaborator |
---|---|
University of Rochester |
United States,
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* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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