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Real-World Study on the Application of Dupilumab in COPD Patients

A Comprehensive Study Protocol on Dupilumab Treatment for Chronic Obstructive Pulmonary Disease (COPD)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500107743
Enrollment
Unknown
Registered
2025-08-18
Start date
2025-08-26
Completion date
Unknown
Last updated
2025-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Interventions

COPD patients using Dupilumab:NA

Sponsors

Shanghai Tenth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1: Patients aged 18-80 years diagnosed with chronic obstructive pulmonary disease (COPD) according to the 2024 Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines; 2: Patients who have received conventional treatment but still exhibit poor symptom control and/or have experienced at least one acute exacerbation in the past year, or are at high risk of acute exacerbation; 3: Patients meeting at least one of the following type 2 inflammation diagnostic criteria: Blood eosinophil count >=150 cells/µL FeNO level >=25 ppb Sputum eosinophil level >=2% Allergen testing: total IgE level >=100 kU/L or specific IgE level >=0.35 IU/L (within the past year); 4: Signed informed consent form.

Exclusion criteria

Exclusion criteria: 1: Comorbidities with other severe respiratory diseases; 2: Hypersensitivity to dupilumab or its excipients; 3: Pregnant or breastfeeding women; 4: Other conditions deemed unsuitable for study participation by the investigator.

Design outcomes

Primary

MeasureTime frame
acute exacerbation rate change;

Secondary

MeasureTime frame
FEV1, FVC change;CAT,SGRQ scores change;Incidence of adverse events over up to 52-week Dupilumab treatment period.;EOS, FeNO, IgE change;the proportion of patients achieving clinical remission with dupilumab in a real-world setting;Clinical treatment costs during dupilumab therapy;

Countries

China

Contacts

Public ContactMin Tan

Shanghai Tenth People's Hospital

mylikes_tm@163.com+86 181 2110 3909

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026