The Study of Chronic Obstructive Pulmonary Disease (COPD) Participants Treated With Dupilumab (STRIDE) Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorSanofi
About this trial
The STRIDE Registry will evaluate the real-world effectiveness and safety of dupilumab in participants with COPD. The primary objective is to describe characteristics of participants newly initiated with dupilumab for COPD. Secondary objectives are to determine whether treatment with dupilumab reduces moderate and/or severe COPD exacerbations; to determine the impact of treatment on lung function in COPD participants; to determine whether treatment with dupilumab improves the quality of life in COPD participants; and to describe safety of dupilumab among COPD participants. The external control cohort will include participants with COPD from the National Patient-Centered Clinical Research Network (PCORnet) consortium who are not being treated with dupilumab. In addition, chest images will be collected and banked for future research projects and consented participants will perform home spirometry.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
COPD patients who are newly referred to start dupilumab treatment
Age ≥ 40 years
Standard of care spirometry performed concurrently with the baseline visit or within 90 days prior to the baseline visit
Disqualifiers
Patients who have contraindication to dupilumab according to the United States Prescribing Information (USPI)
Any condition that, in the opinion of the Investigator, may interfere with the patient's ability to participate in the study, such as short life expectancy, or other comorbidities that can predictably prevent the patient from completing the schedule of assessments
Patients currently participating in any interventional clinical trial The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
Trial population
COPD patients who are newly referred to start dupilumab treatment
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Cohort 1: Dupilumab
Drugmedicine already approved by the FDA
Cohort 2: usual care only
Other interventionUsual care that patients receive
Treatment groups
350 Participants
are divided into 2 treatment groupsGroup A: Cohort 1: COPD participants prescribed dupilumab1 intervention
Group B: Cohort 2: Control COPD participants not prescribed dupilumab1 intervention
Trial outcomes
Primary outcomes
1
Participant Characteristics
Age
Time frame
End of study (24 months after the last participant is enrolled)2
Participant Characteristics
Sex
Time frame
End of study (24 months after the last participant is enrolled)3
Patient Characteristics
Height in meters
Time frame
End of study (24 months after the last participant is enrolled)4
Participant Characteristics
Weight in kilograms
Time frame
End of study (24 months after the last participant is enrolled)Secondary outcomes
1
COPD Exacerbations
(1a) Total number of moderate or severe COPD exacerbations in the 12 and 24 months after enrollment
Time frame
End of Study (24 months after the last participant is enrolled)2
FEV changes
Change from enrollment in FEV at 12 and 24 months after enrollment
Time frame
End of study (2 years after the last participant is enrolled)3
Changes in Quality of Life
(3a) Change from enrollment in St. George's Respiratory Questionnaire (SGRQ) Total Score at 12 and 24 months after enrollment. Minimum score is 0 and maximum score is 100. Higher scores indicate worse health status.
Time frame
End of study (2 years after the last participant is enrolled)4
Events
Major Adverse Cardiovascular Events (MACE), hospitalization, and all cause of death
Time frame
End of study (2 years after the last participant is enrolled) Source ClinicalTrials.gov