Long-term Real-world Study of Dupilumab in COPD : Patient Characteristics, Safety and Patient-reported Outcomes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSanofi
About this trial
The OBS19236 is a retrospective and prospective, non-interventional observational study in COPD patients treated with dupilumab as part of routine clinical care. It will follow-up about 350 to 500 participants over 36 months in up to 50 sites in France.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients willing and able to sign informed consent for use of their pseudonymized clinical data within the present non-intervention study.
Adult patients.
Patients with uncontrolled Chronic Obstructive Pulmonary Disease (COPD) despite long-acting muscarinic antagonist (LAMA)/ Long-acting beta2-agonist (LABA)/ Inhaled Corticosteroid (ICS) (or LAMA/LABA if ICS are not appropriate) therapy and elevated blood eosinophils (a blood eosinophil count ≥ 300 cells/microL).
Patients newly initiated on dupilumab treatment as indicated in the dupilumab summary of product characteristics (SmPC) in the specified label for COPD, determined by the treating physician, and independent of participation in the non-interventional study (NIS).
Disqualifiers
Patient not eligible for dupilumab treatment according to SmPC.
Participation in an ongoing interventional study or participation in an interventional study up to 12 months before enrolment that might, in the treating physician's opinion, influence the assessments for the current study.
Any acute or chronic condition that, in the treating physician's opinion, would limit the patient's ability to complete questionnaires or to participate in this study or impact the interpretation of the results.
Trial population
It is planned to recruit 350 to 500 participants, in up to 50 sites in France.
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
500 Participants
are grouped into 1 trial groupGroup A: Treated cohort
Trial outcomes
Primary outcomes
1
Descriptive statistical analysis of socio-demographics
Time frame
Baseline2
Descriptive statistical analysis of medical disease
Time frame
Baseline3
Descriptive statistical analysis of treatment history
Time frame
Baseline4
Descriptive statistical analysis of clinical disease characteristics (symptoms)
Time frame
In the 1 year prior to Dupilumab initiationSecondary outcomes
1
Annualized rate of Chronic Obstructive Pulmonary Disease (COPD) exacerbations
Time frame
After 12, 24 and 36 months compared to the year before baseline.2
Change in exacerbation rate
Time frame
From treatment start to month 6, 12, 24 and 36.3
Time to first exacerbation
Time frame
Since Dupilumab initiation and during the study period (3 years)4
Cumulative moderate and severe exacerbations
Time frame
Since Dupilumab initiation and during the study period (3 years)Other outcomes
1
Change over time in the Residual Volume (RV)
Time frame
From treatment start to months 6, 12, 24 and 36.2
Change over time in the Functional Residual Capacity (FRC)
Time frame
From treatment start to months 6, 12, 24 and 36.3
Change over time in the Diffusion Lung Capacity for Carbon Monoxide [DLCO]
Time frame
From treatment start to months 6, 12, 24 and 36.4
Number of missed workdays due to Chronic Obstructive Pulmonary Disease (COPD)
Time frame
After 6, 12, 24 and 36 months of dupilumab treatment vs. the year before baseline Source ClinicalTrials.gov