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Dupilumab in Type 2-Inflamed COPD Across the Full Spectrum of Airflow Limitation: An Italian Multicentre Retrospective Cohort Study

NCT07788092 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2026-08-26

No results posted yet for this study

Summary

This multicentre retrospective cohort study describes lung function and patient-reported outcomes in adults with chronic obstructive pulmonary disease (COPD) and type 2 inflammation who received add-on dupilumab in routine clinical care at six Italian centres.

During the study period dupilumab was not reimbursed for COPD in Italy and was provided exclusively through the manufacturer's named-patient compassionate-use programme. Access to that programme required a documented blood eosinophil count of at least 300 cells/microliter, at least two moderate or one severe exacerbation in the preceding 12 months, and persistent symptoms despite maximal inhaled therapy, but set no upper or lower limit on the degree of airflow limitation. As a consequence, the cohort includes participants whose airflow limitation falls outside the post-bronchodilator forced expiratory volume in 1 second (FEV1) window of 30 to 70 percent predicted that was required for entry into the BOREAS and NOTUS registration trials. Post-bronchodilator spirometry, COPD Assessment Test (CAT) score, modified Medical Research Council (mMRC) dyspnoea grade and, where locally available, fractional exhaled nitric oxide (FeNO) were recorded at treatment initiation and at approximately 12 weeks. The variable of primary interest is the change from baseline in post-bronchodilator FEV1 at 12 weeks, the timepoint pre-specified for the lung function endpoint of the registration trials. A pre-specified analysis compares the change in FEV1 between participants whose baseline FEV1 falls inside the 30 to 70 percent predicted window and those whose baseline FEV1 falls outside it. The study is observational and non-interventional. Dupilumab was prescribed independently of the study, according to clinical judgement and the rules of the compassionate-use programme, and no study-specific procedure was performed. Data were abstracted from routine clinical records.

Conditions

  • COPD (Chronic Obstructive Pulmonary Disease)
  • COPD
  • Eosinophilia

Interventions

DRUG

Dupilumab

Dupilumab 300 mg administered subcutaneously every two weeks as add-on therapy to unchanged background inhaled treatment. Treatment was prescribed in routine clinical care, independently of this study, under a named-patient compassionate-use programme. No treatment was assigned by the investigators for the purposes of the study

Sponsors & Collaborators

  • Ospedale San Carlo di Nancy, Roma

    collaborator UNKNOWN

  • Campus Bio-Medico University

    collaborator OTHER

  • S. Andrea Hospital

    collaborator OTHER

  • Azienda Ospedaliera San Camillo Forlanini

    collaborator OTHER

  • Isola Tiberina - Gemelli Isola Hospital, Rome, Italy

    collaborator OTHER

  • Ospedale Cristo Re - Roma

    collaborator UNKNOWN

  • Azienda Ospedaliera di Perugia

    lead OTHER

Principal Investigators

  • Lorenzo Carriera · Azienda Ospedaliera di Perugia

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2026-04-30
Completion
2026-04-30
FDA Drug
Yes

Countries

  • Italy

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07788092 on ClinicalTrials.gov