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

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ClinicalTrials.gov Identifier: NCT03369574
Recruitment Status : Recruiting
First Posted : December 12, 2017
Last Update Posted : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
Li-Xing Man, 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.

Condition or disease Intervention/treatment
Chronic Rhinosinusitis (Diagnosis) Asthma Nasal Polyps Drug: Reslizumab

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 Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observational Study of Chronic Rhinosinusitis Symptoms in Asthma Patients Undergoing Treatment With Reslizumab
Estimated Study Start Date : July 1, 2018
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Reslizumab

Group/Cohort Intervention/treatment
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
reslizumab administration




Primary Outcome Measures :
  1. Mean Sino-Nasal Outcome Test (SNOT)-22 Score [ Time Frame: 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03369574


Contacts
Contact: Paul Allen, PhD 5852765181 Paul_Allen@URMC.Rochester.edu

Locations
United States, New York
University of Rochester Department of Otolaryngology Head and Neck Surgery Recruiting
Rochester, New York, United States, 14642
Contact: Paul Allen, PhD       Paul_Allen@URMC.Rochester.edu   
Principal Investigator: Li-Xing Man, MSc, MD, MPA         
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Li-Xing Man, MSc, MD, MPA University of Rochester

Publications:

Responsible Party: Li-Xing Man, Associate Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT03369574     History of Changes
Other Study ID Numbers: RSRB 60712
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Asthma
Sinusitis
Nasal Polyps
Chronic Disease
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Polyps
Pathological Conditions, Anatomical
Disease Attributes
Pathologic Processes
Reslizumab
Anti-Asthmatic Agents
Respiratory System Agents