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 .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
5
Reslizumab will be administered as per the dose and schedule specified in the arm.
FDG will be administered by IV infusion prior to each PET/CT scan.
Placebo matching to reslizumab will be administered as per the schedule specified in the arm.
Teva Investigational Site 13808
New Brunswick, New Jersey, United States
Part 1: Average Global Lung Glycolysis (GLG) at Baseline (Day 1)
GLG is the total FDG uptake in the whole lung. A region of interest (ROI) was drawn around lung boundary in each axial slice. Standardized uptake value (SUV) mean and area of each ROI was recorded. Using the formula: area\*slice thickness the volume of each slice was calculated. Then the SUVmean of each slice was multiplied by the volume of the corresponding slice, which represented the total FDG uptake in one slice. This number for each slice was summed together to provide GLG of that lung. Average between GLG of right lung and GLG of left lung was reported.
Time frame: Baseline (Day 1) of Part 1
Part 1: Average Global Lung Glycolysis (GLG) at Day 8
GLG is the total FDG uptake in the whole lung. ROI was drawn around lung boundary in each axial slice. SUV mean and area of each ROI was recorded. Using the formula: area\*slice thickness the volume of each slice was calculated. Then the SUVmean of each slice was multiplied by the volume of the corresponding slice, which represented the total FDG uptake in one slice. This number for each slice was summed together to provide GLG of that lung. Average between GLG of right lung and GLG of left lung was reported.
Time frame: Day 8
Part 2: Change From Baseline to Week 4 in GLG
Time frame: Baseline, Week 4
Part 2: Change From Baseline to Week 4 in Lung Parenchyma (LP) SUV Mean
Time frame: Baseline, Week 4
Part 2: Change From Baseline to Week 4 in Blood Eosinophil Counts
Time frame: Baseline, Week 4
Change From Baseline to Week 4 in Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Baseline, Week 4
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Change From Baseline to Week 4 in Fractional Exhaled Nitric Oxide (FeNO)
Time frame: Baseline, Week 4
Change From Baseline to Week 4 in Asthma Quality of Life Questionnaire (AQLQ) Score
Time frame: Baseline, Week 4
Number of Participants With Adverse Events (AEs)
An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. SAEs included death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'.
Time frame: 21 days