Chronic Obstructive Pulmonary Disease(COPD)
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients who are willing and able to sign informed consent for the use of anonymized clinical data in this non-interventional study. 2. 20 years or older 3. Patients who have started dupilumab treatment for COPD in clinical practice by the attending physician. (Use of dupilumab for other conditions or concurrent use of other biologic agents is at the discretion of the treating physician.)
Exclusion criteria
Exclusion criteria: 1. Participation in an ongoing interventional or clinical trial that may affect the assessment of this study, as judged by the treating physician. 2. Patients with acute or chronic diseases that, in the judgment of the treating physician, may affect the completion of questionnaires, participation in this study, or interpretation of the results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Descriptive statistical analysis of demographic characteristics (age, sex, BMI, smoking history) and clinical characteristics (COPD severity, complications, IgE [total and specific], blood eosinophil count, FeNO, respiratory function test findings, COPD Assessment Test [CAT] score, modified Medical Research Council Dyspnea Scale [mMRC], number of exacerbations [one year prior to baseline]). | — |
Secondary
| Measure | Time frame |
|---|---|
| Annualized rate of moderate and severe COPD exacerbations 12 months since initiation of dupilumab compared to the annual exacerbation rate of the previous year Time to the first moderate or severe exacerbations over time. Change over time in pre- and post-bronchodilator FEV1 from study start to month 12. Change over time in pre- and post FEV1/FVC from study start to month 12. Change over time in CAT Score from study start to month 12. Change over time in mMRC Score from study start to month 12. Number of hospitalizations after 12 months of dupilumab treatment vs. the year before study start. Changes in biomarkers (peripheral blood EOS, IgE [total and specific], and FeNO) measured after the initiation of dupilumab. | — |
Contacts
Tohoku University Hospital