Effect of Reslizumab in Chronic Rhinosinusitis

Joshua S. Jacobs

Status and phase: Unknown; Phase 3

Conditions: Sinusitis

Treatments: Drug: Placebo; Drug: Reslizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT02799446

AACR-01

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

Reslizumab

Experimental group

Description:

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

Treatment:

Drug: Reslizumab

Placebo

Placebo Comparator group

Description:

Matching placebo.

Treatment:

Drug: Placebo