Long-term Real-world Study of Dupilumab in COPD : Patient Characteristics, Safety and Patient-reported Outcomes

Official title

Prospective and Retrospective Observational Real-world Study to Characterize Patients With COPD on Dupilumab Long-term Treatment, and Assess Safety and Patient Reported Outcomes

Overview

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.

Detailed description

Study duration per participant is expected to be approximately 36 months.

Primary outcome measures

• Descriptive statistical analysis of socio-demographics [Time frame: Baseline]
• Descriptive statistical analysis of medical disease [Time frame: Baseline]
• Descriptive statistical analysis of treatment history [Time frame: Baseline]
• Descriptive statistical analysis of clinical disease characteristics (symptoms) [Time frame: In the 1 year prior to Dupilumab initiation]
• Descriptive statistical analysis of clinical disease characteristics (exacerbations) [Time frame: In the 2 years prior to Dupilumab initiation]
• Descriptive statistical analysis of clinical disease characteristics (lung function parameters) [Time frame: In the 1 year prior to Dupilumab initiation]
• Descriptive statistical analysis of clinical disease characteristics (max eosinophils [EOS]) [Time frame: In the 1 year prior to Dupilumab initiation]
• Descriptive statistical analysis of clinical disease characteristics (fractional exhaled nitric oxide [FeNO] levels) [Time frame: In the 1 year prior to Dupilumab initiation]
• Descriptive statistical analysis of clinical disease characteristics (immunoglobulin E [IgE] levels) [Time frame: In the 1 year prior to Dupilumab initiation]
• Descriptive statistical analysis of clinical disease characteristics (Global Initiative for Chronic Obstructive Lung Disease (GOLD) grade and group) [Time frame: Baseline]

Secondary outcome measures (12)

• Annualized rate of Chronic Obstructive Pulmonary Disease (COPD) exacerbations [Time frame: After 12, 24 and 36 months compared to the year before baseline.]
• Change in exacerbation rate [Time frame: From treatment start to month 6, 12, 24 and 36.]
• Time to first exacerbation [Time frame: Since Dupilumab initiation and during the study period (3 years)]
• Cumulative moderate and severe exacerbations [Time frame: Since Dupilumab initiation and during the study period (3 years)]
• Change over time in pre- and post-bronchodilator forced expiratory volume in 1 second (FEV1) [Time frame: From treatment start to month 6, 12, 24 and 36.]
• Change over time in pre- and post-bronchodilator Forced Vital Capacity (FVC) [Time frame: From treatment start to month 6, 12, 24 and 36]
• Change over time in pre- and post- bronchodilator forced expiratory volume in 1 second (FEV1)/ Forced vital capacity (FVC) [Time frame: From treatment start to month 6, 12, 24 and 36]
• Change over time in COPD Assessment Test (CAT) Score [Time frame: From treatment start to month 6, 12, 24 and 36.]
• Change over time in modified Medical Research Council (mMRC) score [Time frame: From treatment start to month 6, 12, 24 and 36.]
• Number of hospitalizations during dupilumab treatment vs. the year before dupilumab initiation [Time frame: After 6, 12, 24 and 36 months of dupilumab treatment vs. the year before dupilumab initiation]
• Reason(s) for discontinuation of dupilumab treatment [Time frame: Month 6, 12, 24, and 36]
• Frequency and type of Adverse events (AEs) [Time frame: During the study period (3 years)]

Eligibility criteria

Inclusion criteria

• 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).

Exclusion criteria

• 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.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Other

Study locations

France · 22 centers

• Investigational Site Number : 2500021 — Aix-en-Provence
• Investigational Site Number : 2500043 — Blois
• Investigational Site Number : 2500044 — Brest
• Investigational Site Number : 2500009 — Colmar
• Investigational Site Number : 2500031 — Contamine-sur-Arve
• Investigational Site Number : 2500022 — Juan-les-Pins
• Investigational Site Number : 2500020 — Le Chesnay
• Investigational Site Number : 2500038 — Libourne
• … and 14 more centers

Identifiers

NCT: NCT07380711 · OBS19236

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗