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Effect of Reslizumab in Chronic Rhinosinusitis

Primary Purpose

Sinusitis

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Reslizumab
Placebo
Sponsored by
Joshua S. Jacobs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sinusitis focused on measuring sinusitis, rhinitis, rhinosinusitis, chronic

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Written informed consent
  2. Willingness and ability to comply with the requirements of the study
  3. Female or male patients ages 18-75 at the time of screening
  4. A diagnosis of chronic rhinosinusitis according to the clinical practice guideline (update) of the American academy of otolaryngology - head and neck surgery
  5. Elevated blood eosinophils
  6. Significant findings on computed tomography (CT) scan

Exclusion Criteria:

  1. Unable to sign informed consent form
  2. A woman that is pregnant or nursing a child
  3. Known hypersensitivity to Reslizumab
  4. Active cigarette smoking in the year prior to screening
  5. Known underlying immunodeficiency
  6. History of alcohol or drug abuse in the year prior to screening

Other criteria may apply. Please contact the investigator for more information

Sites / Locations

  • Allergy and Asthma Clinical ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Reslizumab

Placebo

Arm Description

Reslizumab will be administered intravenously every 4 weeks at a dose of 3mg/kg.

Matching placebo.

Outcomes

Primary Outcome Measures

Change in computed tomography (CT) score

Secondary Outcome Measures

Quality of life questionnaire
Smell test
Endoscopy score
Adverse events by body system

Full Information

First Posted
June 10, 2016
Last Updated
January 30, 2018
Sponsor
Joshua S. Jacobs
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1. Study Identification

Unique Protocol Identification Number
NCT02799446
Brief Title
Effect of Reslizumab in Chronic Rhinosinusitis
Official Title
Efficacy of Reslizumab for the Treatment of Chronic Rhinosinusitis A Double Blind, Randomized, Placebo-controlled, Phase III Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
July 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Joshua S. Jacobs

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine whether Reslizumab is effective for the treatment of chronic sinusitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sinusitis
Keywords
sinusitis, rhinitis, rhinosinusitis, chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Reslizumab
Arm Type
Experimental
Arm Description
Reslizumab will be administered intravenously every 4 weeks at a dose of 3mg/kg.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo.
Intervention Type
Drug
Intervention Name(s)
Reslizumab
Intervention Description
Reslizumab 3mg/kg intravenous (IV)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching Placebo intravenous (IV)
Primary Outcome Measure Information:
Title
Change in computed tomography (CT) score
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Quality of life questionnaire
Time Frame
24 weeks
Title
Smell test
Time Frame
24 weeks
Title
Endoscopy score
Time Frame
24 weeks
Title
Adverse events by body system
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent Willingness and ability to comply with the requirements of the study Female or male patients ages 18-75 at the time of screening A diagnosis of chronic rhinosinusitis according to the clinical practice guideline (update) of the American academy of otolaryngology - head and neck surgery Elevated blood eosinophils Significant findings on computed tomography (CT) scan Exclusion Criteria: Unable to sign informed consent form A woman that is pregnant or nursing a child Known hypersensitivity to Reslizumab Active cigarette smoking in the year prior to screening Known underlying immunodeficiency History of alcohol or drug abuse in the year prior to screening Other criteria may apply. Please contact the investigator for more information
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Coordinator
Phone
925-935-2599
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua Jacobs, MD
Organizational Affiliation
Allergy and Asthma Clinical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allergy and Asthma Clinical Research
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
925-935-2599

12. IPD Sharing Statement

Learn more about this trial

Effect of Reslizumab in Chronic Rhinosinusitis

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