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

NCT03369574 | Withdrawn FDA Drug

• 1 other identifier: RSRB 60712
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Rhinosinusitis (Diagnosis); Asthma; Nasal Polyps

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

chronic rhinosinusitis and eosinophilic asthma

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

Drug: Reslizumab

Interventions

Reslizumab DRUG

reslizumab administration

chronic rhinosinusitis and eosinophilic asthma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester Department of Otolaryngology Head and Neck Surgery

Rochester, New York, 14642, United States

Location

Related Publications (19)

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MeSH Terms

Conditions

Disease; Asthma; Nasal Polyps

Interventions

reslizumab

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Nose Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical

Study Officials

• Li-Xing Man, MSc, MD, MPA

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 2, 2017
• First Posted: December 12, 2017
• Study Start: November 14, 2017
• Primary Completion: October 19, 2018
• Study Completion: October 19, 2018
• Last Updated: November 13, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)