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

Withdrawn

• Conditions: Nasal Polyps; Chronic Rhinosinusitis (Diagnosis); Asthma
• Interventions: Drug: Reslizumab

• Registration Number: NCT03369574
• Lead Sponsor: University of Rochester

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.

Study Timeline

• Study Start: 2017-11-14
• Study First Submitted: 2017-12-02
• Study First Submitted QC: 2017-12-08
• Study First Posted: 2017-12-12
• Primary Completion: 2018-10-19
• Study Completion: 2018-10-19
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-07
• Last Update Posted: 2019-11-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
chronic rhinosinusitis and eosinophilic asthma	Reslizumab	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

Primary Outcome Measures

Name	Time	Method
Mean Sino-Nasal Outcome Test (SNOT)-22 Score	1 year	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).

Trial Locations

Locations (1)

University of Rochester Department of Otolaryngology Head and Neck Surgery; 🇺🇸 Rochester, New York, United States