Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Interventions
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or female, aged >= 40 years at the baseline visit. 2. Participants with a confirmed diagnosis of chronic obstructive pulmonary disease (COPD) based on the 2025 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and/or the 2021 Chinese Guidelines for Chronic Obstructive Pulmonary Disease Diagnosis and Treatment at the baseline visit. 3. Initiating Dupilumab (Dupixent®) treatment for COPD (by physician’s discretion). 4. Willing and able to comply with required clinic visits, study procedures and assessments. 5. Able to understand and complete study-related questionnaire. 6. Willing to participate in the study voluntarily and sign the written informed consent. For participants who are disabled, both legal guardian consent and participant assent are required.
Exclusion criteria
Exclusion criteria: 1. Participants who have a contraindication to Dupilumab. 2. Treatment with Dupilumab before the baseline visit. 3. Any condition that, in the opinion of the Investigator, may interfere with participant’s ability to participate in the study, such as short life expectancy, severe cognitive impairment, or other comorbid disease(s) that can predictably prevent the participant from adequately completing the schedule of visits and assessments. 4. Currently participating in any interventional clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Participant sociodemographics (including age, gender, place of residence, smoking/vaping status & smoking/vaping history, etc.);Clinical characteristics (including height and weight, medical/surgical history, concomitant treatments, biomarkers, lung function, etc.); | — |
Secondary
| Measure | Time frame |
|---|---|
| Annualized rate of moderate, severe, and moderate-to-severe exacerbations after initiation of Dupilumab.;Proportion of participants experiencing moderate, severe, and moderate-to-severe exacerbations during study observation period.;Change from baseline of lung function parameters (including pre-and post-bronchodilator forced expiratory volume in one second [FEV1], forced vital capacity [FVC], inspiratory capacity [IC], forced midexpiratory flow [FEF]25%-75%) at Month 3, 6, and 12;Change from baseline of COPD Assessment Test (CAT) score at Month 1, 3, 6, 9, and 12.;CAT response rate at Month 1, 3, 6, 9, and 12 (i.e., defined as the proportion of participants with at least 2 points [= 2 points] reduction of total CAT score from baseline.;Change from baseline of blood EOS at Month 3, 6, and 12.;Dupilumab dosage, frequency, duration.;Reasons for initiation and discontinuation/switching/adjustment of Dupilumab.;Concomitant COPD maintenance treatment patterns for medications (e.g., inhaled corticosteroids [ICS], long-acting inhaled beta2- agonist [LABA], long-acting muscarinic antagonists [LAMA], oral corticosteroids (OCS), macrolide, phosphodiesterase-4 (PDE-4) inhibitor or their combinations, etc.) and non-medication treatments (e.g., pulmonary rehabilitation, oxygen therapy, ventilation support, bronchoscopy, general surgery, etc.);COPD-related HCRU (e.g., clinical visits, emergency visits, hospitalizations [number and duration], direct medical costs, etc.) since initiation of Dupilumab treatment;Incidence of adverse events (AEs) and serious adverse events (SAEs) over up to 24-month Dupilumab treatment period.; | — |
Countries
China
Contacts
Public ContactWeijie Guan
The First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed