Chronic Obstructive Pulmonary Disease COPD
Conditions
Brief summary
The OBS19236 is a retrospective and prospective, non-interventional observational study in COPD patients treated with dupilumab as part of routine clinical care. It will follow-up about 350 to 500 participants over 36 months in up to 50 sites in France.
Detailed description
Study duration per participant is expected to be approximately 36 months.
Interventions
None listed
Sponsors
Sanofi
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients willing and able to sign informed consent for use of their pseudonymized clinical data within the present non-intervention study. * Adult patients. * Patients 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 (a blood eosinophil count ≥ 300 cells/microL). * Patients 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
* Patient not eligible for dupilumab treatment according to SmPC. * Participation in an ongoing interventional study or participation in an interventional 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 patient's ability to complete questionnaires or to participate in this study or impact the interpretation of the results. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Descriptive statistical analysis of socio-demographics | Baseline | — |
| Descriptive statistical analysis of medical disease | Baseline | — |
| Descriptive statistical analysis of treatment history | Baseline | — |
| Descriptive statistical analysis of clinical disease characteristics (symptoms) | In the 1 year prior to Dupilumab initiation | — |
| Descriptive statistical analysis of clinical disease characteristics (exacerbations) | In the 2 years prior to Dupilumab initiation | — |
| Descriptive statistical analysis of clinical disease characteristics (lung function parameters) | In the 1 year prior to Dupilumab initiation | — |
| Descriptive statistical analysis of clinical disease characteristics (max eosinophils [EOS]) | In the 1 year prior to Dupilumab initiation | — |
| Descriptive statistical analysis of clinical disease characteristics (fractional exhaled nitric oxide [FeNO] levels) | In the 1 year prior to Dupilumab initiation | — |
| Descriptive statistical analysis of clinical disease characteristics (immunoglobulin E [IgE] levels) | In the 1 year prior to Dupilumab initiation | — |
| Descriptive statistical analysis of clinical disease characteristics (Global Initiative for Chronic Obstructive Lung Disease (GOLD) grade and group) | Baseline | — |
| Descriptive statistical analysis of clinical disease characteristics (smoking status and pack years (tobacco and cannabis)) | Baseline | — |
| Descriptive statistical analysis of clinical disease characteristics (treated asthma in childhood and concomitant asthma according to the investigator opinion) | Baseline | — |
| Descriptive statistical analysis of clinical disease characteristics (Cardiovascular (CV) comorbidities) | Baseline | — |
| Descriptive statistical analysis of clinical disease characteristics (Otorhinolaryngology (ORL) comorbidities) | Baseline | — |
| Descriptive statistical analysis of clinical disease characteristics (date of Chronic Obstructive Pulmonary Disease (COPD) diagnosis) | Baseline | — |
| Date of COPD diagnosis and GOLD grade/group at COPD diagnosis | Baseline | — |
| Descriptive statistical analysis of clinical disease characteristics (BODE and/or BODEx scores-index for COPD survival) | Baseline | — |
| Descriptive statistical analysis of clinical disease characteristics (history of pulmonary rehabilitation) | Baseline | — |
| Descriptive statistical analysis of Hospital Anxiety and Depression scale (HADS). | Baseline | Score range 0-42, higher values indicating a worse outcome |
| Descriptive statistical analysis of Vaccine status. | Baseline | — |
| Descriptive statistical analysis of Emphysema assessment according to treating physician, based on CT scan | In the last 3 years prior to treatment initiation | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Annualized rate of Chronic Obstructive Pulmonary Disease (COPD) exacerbations | After 12, 24 and 36 months compared to the year before baseline. | — |
| Change in exacerbation rate | From treatment start to month 6, 12, 24 and 36. | — |
| Time to first exacerbation | Since Dupilumab initiation and during the study period (3 years) | — |
| Cumulative moderate and severe exacerbations | Since Dupilumab initiation and during the study period (3 years) | — |
| Change over time in pre- and post-bronchodilator forced expiratory volume in 1 second (FEV1) | From treatment start to month 6, 12, 24 and 36. | — |
| Change over time in pre- and post-bronchodilator Forced Vital Capacity (FVC) | From treatment start to month 6, 12, 24 and 36 | — |
| Change over time in pre- and post- bronchodilator forced expiratory volume in 1 second (FEV1)/ Forced vital capacity (FVC) | From treatment start to month 6, 12, 24 and 36 | — |
| Change over time in COPD Assessment Test (CAT) Score | From treatment start to month 6, 12, 24 and 36. | Score range 0-40, higher values indicating a worse outcome |
| Change over time in modified Medical Research Council (mMRC) score | From treatment start to month 6, 12, 24 and 36. | Score range 0-4, higher values indicating a worse outcome |
| Number of hospitalizations during dupilumab treatment vs. the year before dupilumab initiation | After 6, 12, 24 and 36 months of dupilumab treatment vs. the year before dupilumab initiation | — |
| Reason(s) for discontinuation of dupilumab treatment | Month 6, 12, 24, and 36 | — |
| Frequency and type of Adverse events (AEs) | During the study period (3 years) | — |
| Frequency and type of possible dupilumab-related treatment-emergent adverse events (TEAEs) | During the study period (3 years) | — |
Countries
France
Contacts
CONTACTTrial Transparency email recommended (Toll free for US & Canada)
Outcome results
None listed