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.

Baseline up to 12 months

Change from Baseline in 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.

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.

Baseline

Analysis of Clinical Disease Characteristics including Exacerbations

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

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.

Baseline

Analysis of Clinical Disease Characteristics including Eosinophils [EOS] Levels

Analysis of clinical disease characteristics including EOS levels.

Baseline

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

Analysis of clinical disease characteristics including FeNO levels.

Baseline

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

Analysis of clinical disease characteristics including IgE levels.

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.

Baseline

Analysis of Clinical Disease Characteristics including Smoking Status and Pack Years

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

Baseline

Analysis of Clinical Disease Characteristics including Comorbidities

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

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.

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.

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.

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.

Baseline to up to 6, 12 and 24 months

Cumulative Moderate and Severe Exacerbations Over Time

Cumulative moderate and severe exacerbations over time

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.

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.

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.

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.

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.

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.

Baseline

Frequency of Adverse Events (AEs) During the Observation Period

Frequency of AEs will be evaluated during the observation period.

Baseline to up to 24 months

Type of AEs

Type of AEs will be evaluated during the observation period.

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.

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.

Baseline to up to 24 months

Occurrence of Product Technical Complaints (PTCs)

Occurrence of PTCs will be evaluated.

Baseline to up to 6, 12 and 24 months