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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Recruitment Status : Withdrawn (Study personnel diverted to other activities and the study was not commenced)
First Posted : December 12, 2017
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Li-Xing Man, University of Rochester

Tracking Information
First Submitted Date December 2, 2017
First Posted Date December 12, 2017
Last Update Posted Date November 13, 2019
Actual Study Start Date November 14, 2017
Actual Primary Completion Date October 19, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 8, 2017)
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).
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03369574 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Chronic Rhinosinusitis (Diagnosis)
  • Asthma
  • Nasal Polyps
Intervention Drug: Reslizumab
reslizumab administration
Study Groups/Cohorts 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
Intervention: Drug: Reslizumab
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: November 7, 2019)
0
Original Estimated Enrollment
 (submitted: December 8, 2017)
20
Actual Study Completion Date October 19, 2018
Actual Primary Completion Date October 19, 2018   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03369574
Other Study ID Numbers RSRB 60712
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Li-Xing Man, University of Rochester
Study Sponsor University of Rochester
Collaborators Not Provided
Investigators
Principal Investigator: Li-Xing Man, MSc, MD, MPA University of Rochester
PRS Account University of Rochester
Verification Date November 2019