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Effect of Reslizumab in Chronic Rhinosinusitis

This study is currently recruiting participants.
Verified March 2017 by Joshua S. Jacobs, Allergy and Asthma Clinical Research Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02799446
First Posted: June 14, 2016
Last Update Posted: March 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Joshua S. Jacobs, Allergy and Asthma Clinical Research Inc.
  Purpose
The purpose of this study is to determine whether Reslizumab is effective for the treatment of chronic sinusitis.

Condition Intervention Phase
Sinusitis Drug: Reslizumab Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Reslizumab for the Treatment of Chronic Rhinosinusitis A Double Blind, Randomized, Placebo-controlled, Phase III Trial

Resource links provided by NLM:


Further study details as provided by Joshua S. Jacobs, Allergy and Asthma Clinical Research Inc.:

Primary Outcome Measures:
  • Change in computed tomography (CT) score [ Time Frame: 24 weeks ]

Secondary Outcome Measures:
  • Quality of life questionnaire [ Time Frame: 24 weeks ]
  • Smell test [ Time Frame: 24 weeks ]
  • Endoscopy score [ Time Frame: 24 weeks ]
  • Adverse events by body system [ Time Frame: 24 weeks ]

Estimated Enrollment: 30
Study Start Date: June 2016
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Reslizumab
Reslizumab will be administered intravenously every 4 weeks at a dose of 3mg/kg.
Drug: Reslizumab
Reslizumab 3mg/kg intravenous (IV)
Placebo Comparator: Placebo
Matching placebo.
Drug: Placebo
Matching Placebo intravenous (IV)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
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): NCT02799446


Contacts
Contact: Dipti Patel 925-935-2599
Contact: Carolyn Doss 925-935-2599

Locations
United States, California
Allergy and Asthma Clinical Research Recruiting
Walnut Creek, California, United States, 94598
Contact: Dipti Patel    925-935-2599      
Contact: Carolyn Doss    925-935-2599      
Sponsors and Collaborators
Joshua S. Jacobs
Investigators
Principal Investigator: Joshua Jacobs, MD Allergy and Asthma Clinical Research
  More Information

Responsible Party: Joshua S. Jacobs, MD, Allergy and Asthma Clinical Research Inc.
ClinicalTrials.gov Identifier: NCT02799446     History of Changes
Other Study ID Numbers: AACR-01
First Submitted: June 10, 2016
First Posted: June 14, 2016
Last Update Posted: March 14, 2017
Last Verified: March 2017

Keywords provided by Joshua S. Jacobs, Allergy and Asthma Clinical Research Inc.:
sinusitis, rhinitis, rhinosinusitis, chronic

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Reslizumab
Anti-Asthmatic Agents
Respiratory System Agents