This study is researching a drug called dupilumab, referred to as "study drug". The study is focused on people diagnosed with COPD to determine if the study drug, in addition to standard of care treatment for COPD, might reduce the reoccurrence of a COPD exacerbation (a "flare-up") happening within the study treatment duration (around 90 days). The study is looking at another research question: • What side effects may happen from taking the study drug
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
754
Administered per the protocol
Administered per the protocol
Time to first all-cause event
All-cause event may include non-elective hospital readmission, Emergency Department (ED)/urgent care visit, or death
Time frame: Through day 90
Number of moderate or severe COPD exacerbations
Time frame: Through day 90
Time to first COPD-related event
COPD-related event may include non-elective hospital readmission, Emergency Department (ED)/urgent care visit, or death
Time frame: Through day 90
Time to first moderate and/or severe COPD exacerbation
Time frame: Through day 90
Number of all-cause non-elective hospital readmissions
Time frame: Through day 90
Number of ED visits
Time frame: Through day 90
Number of COPD-related hospital readmissions
Time frame: Through day 90
Number of COPD-related ED visits
Time frame: Through day 90
Number of all-cause deaths
Time frame: Through day 90
Number of COPD-related deaths
Time frame: Through day 90
Occurrence of all-cause non-elective hospital readmissions
Time frame: Through day 60
Occurrence of all-cause ED visits
Time frame: Through day 60
Occurrence of all-cause deaths
Time frame: Through day 60
Occurrence of COPD-related hospital readmissions
Time frame: Through day 60
Occurrence of ED visits
Time frame: Through day 60
Occurrence of deaths
Time frame: Through day 60
Change in Chronic Airways Assessment Test (CAAT) score
CAAT is a PRO measure that assesses the impact of lung disease on a person's life using an 8-item questionnaire with a 40-point scale with higher scores indicating worse disease.
Time frame: From baseline through day 90
Change in EXAcerbation of Chronic pulmonary disease Tool (EXACT) questionnaire score
EXACT is a patient-reported daily diary that captures respiratory symptoms in COPD using a 14-item questionnaire with a 0 to 100-point scale with higher scores indicating worse disease symptoms.
Time frame: From baseline through day 90
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Through day 90
Occurrence of Serious Adverse Events (SAEs)
Time frame: Through day 90
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