Effect of Reslizumab in Chronic Rhinosinusitis

January 30, 2018 updated by: Joshua S. Jacobs

Efficacy of Reslizumab for the Treatment of Chronic Rhinosinusitis A Double Blind, Randomized, Placebo-controlled, Phase III Trial

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Walnut Creek, California, United States, 94598
        • Recruiting
        • Allergy and Asthma Clinical Research
        • Contact:
          • Phone Number: 925-935-2599

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Matching placebo.
Drug: Placebo
Matching Placebo intravenous (IV)
Experimental: Reslizumab
Reslizumab will be administered intravenously every 4 weeks at a dose of 3mg/kg.
Drug: Reslizumab
Reslizumab 3mg/kg intravenous (IV)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in computed tomography (CT) score
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life questionnaire
Time Frame: 24 weeks
24 weeks
Smell test
Time Frame: 24 weeks
24 weeks
Endoscopy score
Time Frame: 24 weeks
24 weeks
Adverse events by body system
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joshua S. Jacobs

Investigators

  • Principal Investigator: Joshua Jacobs, MD, Allergy and Asthma Clinical Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

July 1, 2019

Study Completion (Anticipated)

July 1, 2019

Study Registration Dates

First Submitted

June 10, 2016

First Submitted That Met QC Criteria

June 10, 2016

First Posted (Estimate)

June 14, 2016

Study Record Updates

Last Update Posted (Actual)

February 1, 2018

Last Update Submitted That Met QC Criteria

January 30, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AACR-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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