Effect of Reslizumab in Chronic Rhinosinusitis

Sinusitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02799446
• Other study ID #: AACR-01
• Status: Recruiting
• Phase: Phase 3
• First received: June 10, 2016
• Last updated: January 30, 2018
• Start date: June 2016
• Est. completion date: July 2019

Study information

• Verified date: January 2018
• Source: Allergy and Asthma Clinical Research Inc.
• Contact: Study Coordinator
• Phone: 925-935-2599
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Sinusitis

Intervention

Drug:
• Reslizumab
Reslizumab 3mg/kg intravenous (IV)
• Placebo
Matching Placebo intravenous (IV)

Locations

Country	Name	City	State
United States	Allergy and Asthma Clinical Research	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Joshua S. Jacobs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in computed tomography (CT) score		24 weeks
Secondary	Quality of life questionnaire		24 weeks
Secondary	Smell test		24 weeks
Secondary	Endoscopy score		24 weeks
Secondary	Adverse events by body system		24 weeks