The primary objective of the study is to demonstrate that dupilumab treatment improves exercise capacity in patients with moderate-to-severe asthma. The secondary objectives of the study are: * To demonstrate that dupilumab treatment increases physical activity of daily living in patients with moderate-to-severe asthma * To demonstrate that dupilumab treatment improves pre- and post-exercise lung function in patients with moderate-to-severe asthma
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
Pre-filled syringe administered by subcutaneous (SC) injections
Pre-filled syringe administered by subcutaneous (SC)
Change From Baseline to Week 12 in Constant Work Rate Exercise Endurance Time - CWRET (Constant Work Rate Exercise Test)
CWRET (Constant Work Rate Exercise Test) will be performed on an electromagnetically-braked cycle ergometer in an exercise physiology laboratory overseen by a trained pulmonologist or medical doctor designee.
Time frame: Up to week 12
Change From Baseline to Week 12 in Average Number of Steps Walked Per Day
Based on accelerometry data
Time frame: Up to week 12
Change From Baseline to Week 12 in Total Energy Expenditure
Metabolic equivalents of tasks \[METs\]. Based on accelerometry data
Time frame: Up to week 12
Change From Baseline to Week 12 in the Mean Duration of Moderate-to-vigorous Physical Activity
Defined as ≥3 METs. Based on accelerometry data
Time frame: Up to week 12
Change From Baseline to Week 12 in Pre- and Post-exercise Forced Expiratory Volume in One Second (FEV1)
Based on spirometry data
Time frame: Up to week 12
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Palos Verdes Medical Group (PVMG); Peninsula Research Associates (PRA)
Rolling Hills Estates, California, United States
UCLA Medical Center - Harbor
Torrance, California, United States
Allianz Research Institute
Westminster, California, United States
University of Iowa Hospitals & Clinics-Roy J. and Lucille A. Carver College of Medicine
Iowa City, Iowa, United States
University Of Kansas Medical Center
Kansas City, Kansas, United States
Infinity Medical Research
North Dartmouth, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
American Health Research
Charlotte, North Carolina, United States
UH Cleveland Medical Center
Cleveland, Ohio, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
...and 20 more locations