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

Официальное название

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

Обзор

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.

Подробное описание

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

Первичные конечные точки

• Descriptive statistical analysis of socio-demographics [Срок оценки: Baseline]
• Descriptive statistical analysis of medical disease [Срок оценки: Baseline]
• Descriptive statistical analysis of treatment history [Срок оценки: Baseline]
• Descriptive statistical analysis of clinical disease characteristics (symptoms) [Срок оценки: In the 1 year prior to Dupilumab initiation]
• Descriptive statistical analysis of clinical disease characteristics (exacerbations) [Срок оценки: In the 2 years prior to Dupilumab initiation]
• Descriptive statistical analysis of clinical disease characteristics (lung function parameters) [Срок оценки: In the 1 year prior to Dupilumab initiation]
• Descriptive statistical analysis of clinical disease characteristics (max eosinophils [EOS]) [Срок оценки: In the 1 year prior to Dupilumab initiation]
• Descriptive statistical analysis of clinical disease characteristics (fractional exhaled nitric oxide [FeNO] levels) [Срок оценки: In the 1 year prior to Dupilumab initiation]
• Descriptive statistical analysis of clinical disease characteristics (immunoglobulin E [IgE] levels) [Срок оценки: 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) [Срок оценки: Baseline]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Франция · 22 центра

• 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
• … и ещё 14 центров

Идентификаторы

NCT: NCT07380711 · OBS19236

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗