NCT02937168

An Imaging Study Using PET/CT to Characterize the Effect of Intravenous Reslizumab on Airway Inflammation

Distribution of Eosinophils in Asthma After Reslizumab (DEAR). A 7-Week, Placebo-Controlled, Double-Blinded, Parallel-Group, Imaging Study Using Positron Emission Tomography/Computer Tomography (PET/CT) to Characterize the Effect of Intravenous Reslizumab on Airway Inflammation in Patients With Eosinophilic Asthma

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is an exploratory study with the following primary objectives: 1) to establish that PET/CT of the lung can reliably distinguish healthy, non-asthmatic participants from participants with severe asthma and an eosinophilic phenotype and 2) to examine the utility of PET/CT for demonstrating that reslizumab produces a reduction in lung inflammation in participants with severe asthma and an eosinophilic phenotype .

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Reslizumab	Reslizumab will be administered as per the dose and schedule specified in the arm.
DRUG	Fludeoxyglucose F 18 (FDG)	FDG will be administered by IV infusion prior to each PET/CT scan.
DRUG	Placebo	Placebo matching to reslizumab will be administered as per the schedule specified in the arm.

Timeline

• Start date: 2017-05-08
• Primary completion: 2017-05-24
• Completion: 2017-05-24
• First posted: 2016-10-18
• Last updated: 2021-11-09
• Results posted: 2019-08-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study