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Effect of Reslizumab in Chronic Rhinosinusitis

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ClinicalTrials.gov Identifier: NCT02799446
Recruitment Status : Recruiting
First Posted : June 14, 2016
Last Update Posted : March 14, 2017
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Sinusitis Drug: Reslizumab Drug: Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Study Start Date : June 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis
Drug Information available for: Reslizumab
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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)


Outcome Measures

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

Secondary Outcome Measures :
  1. Quality of life questionnaire [ Time Frame: 24 weeks ]
  2. Smell test [ Time Frame: 24 weeks ]
  3. Endoscopy score [ Time Frame: 24 weeks ]
  4. Adverse events by body system [ Time Frame: 24 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: June 14, 2016    Key Record Dates
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