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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1314-5561 | Registry Identifier | ICTRP |
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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dupilumab | Drug | This study will not administer any treatment, only observe the treatment as prescribed in real world clinical practice. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Participants will be screened, enrolled, and documented by their treating physician. To avoid any selection bias, all eligible participants will be invited to participate in this study in the order in which their eligibility is determined (consecutive recruitment). Participants will be treated within clinical routine practice and according to the current standard of care. Participants who permanently discontinue dupilumab treatment and therefore terminate the study prior to the last visit at month 24 will be requested to complete an Early Termination visit.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency email recommended (Toll free for US & Canada) | Contact | 800-633-1610 | option 6 | Contact-US@sanofi.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number: DE18 | Recruiting | Auerbach | 08209 | Germany | ||
| Investigational Site Number: DE21 |
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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| 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 |
| Recruiting |
| Augsburg |
| 86152 |
| Germany |
| Investigational Site Number: DE13 | Recruiting | Bad Homburg | 61350 | Germany |
| Investigational Site Number: DE19 | Recruiting | Berlin | 10717 | Germany |
| Investigational Site Number: DE02 | Recruiting | Berlin | 14163 | Germany |
| Investigational Site Number: DE29 | Recruiting | Burgwedel | 30938 | Germany |
| Investigational Site Number: DE01 | Recruiting | Darmstadt | 64283 | Germany |
| Investigational Site Number: DE09 | Recruiting | Erkelenz | 41812 | Germany |
| Investigational Site Number: DE06 | Recruiting | Flensburg | 24937 | Germany |
| Investigational Site Number: DE08 | Recruiting | Fürstenwalde | 15517 | Germany |
| Investigational Site Number: DE03 | Recruiting | Hamburg | 20354 | Germany |
| Investigational Site Number: DE04 | Recruiting | Hamburg | 22459 | Germany |
| Investigational Site Number: DE07 | Recruiting | Hohenstein-Ernstthal | 09337 | Germany |
| Investigational Site Number: DE10 | Recruiting | Itzehoe | 25524 | Germany |
| Investigational Site Number: DE24 | Recruiting | Kaiserslauten | 67655 | Germany |
| Investigational Site Number: DE25 | Recruiting | Lüneburg | 21339 | Germany |
| Investigational Site Number: DE20 | Recruiting | Marburg | 35037 | Germany |
| Investigational Site Number: DE14 | Recruiting | Markkleeberg | 04416 | Germany |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C582203 | dupilumab |
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