Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGDupilumab
This study will not administer any treatment, only observe the treatment as prescribed in real world clinical practice.
Sponsors
Regeneron Pharmaceuticals
Sanofi
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in COPD Assessment Test (CAT) Score | Baseline up to 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analysis of Socio-demographics, Medical Disease and Treatment History | Baseline | Demographic data (age, sex \[f/m\], ethnicity, height, weight, BMI, vaccination status, smoking status, pack years) will be collected. |
| Analysis of Clinical Disease Characteristics including Exacerbations | Baseline | Number and severity grade of exacerbations in the year before study start will be assessed. |
| Analysis of Clinical Disease Characteristics including Lung Function Parameters | Baseline | 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. |
| Analysis of Clinical Disease Characteristics including Eosinophils [EOS] Levels | Baseline | Analysis of clinical disease characteristics including EOS levels. |
| Analysis of Clinical Disease Characteristics including Fractional Exhaled Nitric Oxide [FeNO] Levels | Baseline | Analysis of clinical disease characteristics including FeNO levels. |
| Analysis of Clinical Disease Characteristics including Immunoglobulin E [IgE] Levels | Baseline | Analysis of clinical disease characteristics including IgE levels. |
| Analysis of Clinical Disease Characteristics including Current Global Initiative for Chronic Obstructive Lung Disease (GOLD) Grade and Group | Baseline | Analysis of clinical disease characteristics including current GOLD grade and group. |
| Analysis of Clinical Disease Characteristics including Smoking Status and Pack Years | Baseline | Analysis of clinical disease characteristics including smoking status and pack years. |
| Analysis of Clinical Disease Characteristics including Comorbidities | Baseline | Current and previous comorbidities (such as chronic rhinosinusitis, asthma, allergies, or cardiovascular comorbidities) will be assessed. |
| Analysis of Clinical Disease Characteristics including Date of COPD Diagnosis and GOLD Grade/Group at COPD Diagnosis | Baseline | Analysis of clinical disease characteristics including date of COPD diagnosis and GOLD grade/group at COPD diagnosis. |
| Annualized Rate of Moderate and Severe COPD Exacerbations | Baseline to up to 12 and 24 months | Annualized rate of moderate and severe COPD exacerbations after 12 and 24 months versus the year before baseline. |
| Change in Rate of Moderate and Severe Exacerbations | Baseline to up to 6, 12 and 24 months | Change in rate of moderate and severe exacerbations will be assessed. |
| Change from Baseline in CAT Score | Baseline to up to 6 months and 24 months | 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. |
| Cumulative Moderate and Severe Exacerbations Over Time | Baseline to up to 6, 12 and 24 months | Cumulative moderate and severe exacerbations over time |
| Change Over Time in Pre- and Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) | Baseline to up to 6, 12 and 24 months | Change over time in pre- and post-bronchodilator FEV1 from study start. |
| Change Over Time in Bronchodilator FEV1/Forced Vital Capacity (FVC) | Baseline to up to 6, 12 and 24 months | Change over time in pre- and post- bronchodilator FEV1/FVC from study start. |
| Change Over Time in Modified Medical Research Council (mMRC) | Baseline to up to 6, 12 and 24 months | Change over time in mMRC from study start. |
| Number of Missed Workdays due to COPD | Baseline to up to 6, 12 and 24 months | Number of missed workdays due to COPD during the last year before baseline and after dupilumab treatment. |
| Number of Hospitalization After Dupilumab Treatment | Baseline to up to 6, 12 and 24 months | Number of hospitalizations after dupilumab treatment versus the year before study start. |
| Reason(s) for Initiation of Dupilumab Treatment | Baseline | Reason(s) for initiation of dupilumab treatment will be evaluated. |
| Frequency of Adverse Events (AEs) During the Observation Period | Baseline to up to 24 months | Frequency of AEs will be evaluated during the observation period. |
| Type of AEs | Baseline to up to 24 months | Type of AEs will be evaluated during the observation period. |
| Frequency of Possible Dupilumab-Related Treatment Emergent AEs (TEAEs) | Baseline to up to 24 months | Frequency of possible dupilumab-related TEAEs will be evaluated during the observational period. |
| Type of Possible Dupilumab-Related TEAEs | Baseline to up to 24 months | Type of possible dupilumab-related TEAEs will be evaluated during the observational period. |
| Occurrence of Product Technical Complaints (PTCs) | Baseline to up to 6, 12 and 24 months | Occurrence of PTCs will be evaluated. |
| Time to First Moderate or Severe Exacerbation Since Study Start | Baseline to up to 6, 12 and 24 months | Time to first moderate or severe exacerbation since study start. |
Countries
Germany
Contacts
Primary ContactTrial Transparency email recommended (Toll free for US & Canada)
Outcome results
None listed