Study to Evaluate Long-term Effectiveness and Safety, Patient Characteristics and Subjective Patient-reported Outcomes of Dupilumab in Patients With Chronic Obstructive Pulmonary Disease (COPD) Under Real-world Conditions

Sanofi350 enrolled

Overview

Study to evaluate the change of health-related quality of life, patient characteristics, efficacy and safety in Chronic Obstructive Pulmonary Disease (COPD) patients with Dupilumab therapy in a real-world setting over 24 months.

Non-interventional Study. Patients receive Dupilumab in accordance with the summary of product characteristics in a real-world setting. The Dupilumab initiation must be independent of the study recruitment and patient data is documented based on clinical routine.

Study Type

OBSERVATIONAL

Enrollment

350

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DupilumabDRUG

This study will not administer any treatment, only observe the treatment as prescribed in real world clinical practice.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participants willing and able to sign informed consent for use of their pseudonymized clinical data within the present non-intervention study. * Adult participants. * Participants 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 * Participants 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: * Participants not eligible for dupilumab treatment according to SmPC. * Participation in an ongoing interventional or observational study or participation in an interventional or observational 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 participants´s ability to complete questionnaires or to participate in this study or impact the interpretation of the results. * Participants hospitalized due to an exacerbation of their COPD within the last 4 weeks prior to enrolment.

Locations (18)

Investigational Site Number: DE18

Auerbach, Germany

RECRUITING

Outcomes

Primary Outcomes

Change from Baseline in COPD Assessment Test (CAT) Score

The COPD Assessment Test (CAT) is a questionnaire to assess the health status and quality of life of people with COPD. The questionnaire consists of eight simple statements, which participants answer using a numerical scale. The CAT score ranges from 0 to 40, with lower scores indicating a better health status.

Time frame: Baseline up to 12 months

Secondary Outcomes

Change from Baseline in CAT Score

Time frame: Baseline to up to 6 months and 24 months

Analysis of Socio-demographics, Medical Disease and Treatment History

Demographic data (age, sex \[f/m\], ethnicity, height, weight, BMI, vaccination status, smoking status, pack years) will be collected.

Time frame: Baseline

Analysis of Clinical Disease Characteristics including Exacerbations

Number and severity grade of exacerbations in the year before study start will be assessed.

Time frame: Baseline

Analysis of Clinical Disease Characteristics including Lung Function Parameters

Lung function parameters such as forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), FEV1/FVC, total lung capacity (TLC), residual volume (RV), sRtot, Diffusing capacity of the lungs for carbon monoxide (DLCO), DLCO/VA, Rtot, oxygen saturation in the blood will be assessed.

Time frame: Baseline

Analysis of Clinical Disease Characteristics including Eosinophils [EOS] Levels

Central Contacts

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610 Contact-US@sanofi.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Investigational Site Number: DE21

Investigational Site Number: DE13

Bad Homburg, Germany

RECRUITING

Investigational Site Number: DE19

Berlin, Germany

RECRUITING

Investigational Site Number: DE02

Berlin, Germany

RECRUITING

Investigational Site Number: DE29

Burgwedel, Germany

RECRUITING

Investigational Site Number: DE01

Darmstadt, Germany

RECRUITING

Investigational Site Number: DE09

Erkelenz, Germany

RECRUITING

Investigational Site Number: DE06

Flensburg, Germany

RECRUITING

Investigational Site Number: DE08

Fürstenwalde, Germany

RECRUITING

...and 8 more locations

Analysis of clinical disease characteristics including EOS levels.

Time frame: Baseline

Analysis of Clinical Disease Characteristics including Fractional Exhaled Nitric Oxide [FeNO] Levels

Analysis of clinical disease characteristics including FeNO levels.

Time frame: Baseline

Analysis of Clinical Disease Characteristics including Immunoglobulin E [IgE] Levels

Analysis of clinical disease characteristics including IgE levels.

Time frame: Baseline

Analysis of Clinical Disease Characteristics including Current Global Initiative for Chronic Obstructive Lung Disease (GOLD) Grade and Group

Analysis of clinical disease characteristics including current GOLD grade and group.

Time frame: Baseline

Analysis of Clinical Disease Characteristics including Smoking Status and Pack Years

Analysis of clinical disease characteristics including smoking status and pack years.

Time frame: Baseline

Analysis of Clinical Disease Characteristics including Comorbidities

Current and previous comorbidities (such as chronic rhinosinusitis, asthma, allergies, or cardiovascular comorbidities) will be assessed.

Time frame: Baseline

Analysis of Clinical Disease Characteristics including Date of COPD Diagnosis and GOLD Grade/Group at COPD Diagnosis

Analysis of clinical disease characteristics including date of COPD diagnosis and GOLD grade/group at COPD diagnosis.

Time frame: Baseline

Annualized Rate of Moderate and Severe COPD Exacerbations

Annualized rate of moderate and severe COPD exacerbations after 12 and 24 months versus the year before baseline.

Time frame: Baseline to up to 12 and 24 months

Change in Rate of Moderate and Severe Exacerbations

Change in rate of moderate and severe exacerbations will be assessed.

Time frame: Baseline to up to 6, 12 and 24 months

Time to First Moderate or Severe Exacerbation Since Study Start

Time to first moderate or severe exacerbation since study start.

Time frame: Baseline to up to 6, 12 and 24 months

Cumulative Moderate and Severe Exacerbations Over Time

Cumulative moderate and severe exacerbations over time

Time frame: Baseline to up to 6, 12 and 24 months

Change Over Time in Pre- and Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)

Change over time in pre- and post-bronchodilator FEV1 from study start.

Time frame: Baseline to up to 6, 12 and 24 months

Change Over Time in Bronchodilator FEV1/Forced Vital Capacity (FVC)

Change over time in pre- and post- bronchodilator FEV1/FVC from study start.

Time frame: Baseline to up to 6, 12 and 24 months

Change Over Time in Modified Medical Research Council (mMRC)

Change over time in mMRC from study start.

Time frame: Baseline to up to 6, 12 and 24 months

Number of Missed Workdays due to COPD

Number of missed workdays due to COPD during the last year before baseline and after dupilumab treatment.

Time frame: Baseline to up to 6, 12 and 24 months

Number of Hospitalization After Dupilumab Treatment

Number of hospitalizations after dupilumab treatment versus the year before study start.

Time frame: Baseline to up to 6, 12 and 24 months

Reason(s) for Initiation of Dupilumab Treatment

Reason(s) for initiation of dupilumab treatment will be evaluated.

Time frame: Baseline

Frequency of Adverse Events (AEs) During the Observation Period

Frequency of AEs will be evaluated during the observation period.

Time frame: Baseline to up to 24 months

Type of AEs

Type of AEs will be evaluated during the observation period.

Time frame: Baseline to up to 24 months

Frequency of Possible Dupilumab-Related Treatment Emergent AEs (TEAEs)

Frequency of possible dupilumab-related TEAEs will be evaluated during the observational period.

Time frame: Baseline to up to 24 months

Type of Possible Dupilumab-Related TEAEs

Type of possible dupilumab-related TEAEs will be evaluated during the observational period.

Time frame: Baseline to up to 24 months

Occurrence of Product Technical Complaints (PTCs)

Occurrence of PTCs will be evaluated.

Time frame: Baseline to up to 6, 12 and 24 months