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

NCT07788092 | Completed FDA Drug

• 2 other identifiers: PN002Comitato Etico Regione Umbria
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 6

Brief 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

Keywords

dupilumab; biologic therapy; eosinophilic COPD; Type 2 Inflammation; Eosinophils; FEV1; compassionate use; Real-World Evidence

Outcome Measures

Primary Outcomes (1)

• Change from baseline in post-bronchodilator FEV1 at 12 weeks

  Post-bronchodilator forced expiratory volume in 1 second (FEV1), measured in millilitres by spirometry performed according to ATS/ERS technical standards. Change is calculated as the value at 12 weeks minus the value at baseline. Positive values indicate a higher FEV1 at 12 weeks.

  Baseline and 12 weeks after the first dose of dupilumab

Secondary Outcomes (7)

• Change from baseline in post-bronchodilator FEV1 percent predicted at 12 weeks

  Baseline and 12 weeks

• Change from baseline in post-bronchodilator FEV1 z-score at 12 weeks

  Baseline and 12 weeks

• Change from baseline in post-bronchodilator forced vital capacity at 12 weeks

  Baseline and 12 weeks

• Change from baseline in COPD Assessment Test total score at 12 weeks

  Baseline and 12 weeks

• Number of participants with an increase in post-bronchodilator FEV1 of at least 100 mL at 12 weeks

  Baseline and 12 weeks

Other Outcomes (3)

• Number of participants with baseline post-bronchodilator FEV1 outside the 30 to 70 percent predicted range

  Baseline

• Change from baseline in fractional exhaled nitric oxide at 12 weeks

  Baseline and 12 weeks

• Number of participants who died during follow-up

  From the first dose of dupilumab and up to 24 weeks

Study Arms (1)

Type 2-inflamed COPD treated with dupilumab

Consecutive adults with a physician diagnosis of COPD and a blood eosinophil count of at least 300 cells/microliter who started dupilumab 300 mg subcutaneously every two weeks as add-on therapy to maximal inhaled treatment, through the manufacturer's named-patient compassionate-use programme, between October 2024 and April 2026 at one of six participating Italian centres

Drug: Dupilumab

Interventions

Dupilumab DRUG

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

Also known as: Dupixent

Type 2-inflamed COPD treated with dupilumab

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive adults with a physician diagnosis of COPD and type 2 inflammation who started add-on dupilumab in routine clinical care at six Italian secondary and tertiary respiratory or internal medicine centres between October 2024 and April 2026, all through the manufacturer's named-patient compassionate-use programme.

You may qualify if:

• Age 18 years or older
• Physician diagnosis of COPD with post-bronchodilator FEV1/FVC ratio below 0.70
• Documented blood eosinophil count of at least 300 cells/microliter at screening
• At least two moderate or one severe COPD exacerbation in the previous 12 months
• Persistent symptoms despite maximal inhaled therapy
• Started dupilumab 300 mg subcutaneously every two weeks as add-on therapy between October 2024 and April 2026 under the manufacturer's named-patient compassionate-use programme
• Post-bronchodilator spirometry available at baseline and at approximately 12 weeks

You may not qualify if:

• Dupilumab started for a primary indication other than COPD
• Post-bronchodilator spirometry not available at baseline or at the 12-week assessment
• Pre-bronchodilator values only, with no post-bronchodilator measurement recorded

Sponsors & Collaborators

• Azienda Ospedaliera di Perugia: lead
• Ospedale San Carlo di Nancy, Roma: collaborator
• Ospedale Cristo Re - Roma: collaborator
• Campus Bio-Medico University: collaborator
• S. Andrea Hospital: collaborator
• Azienda Ospedaliera San Camillo Forlanini: collaborator
• Isola Tiberina - Gemelli Isola Hospital, Rome, Italy: collaborator

Study Sites (6)

Azienda Ospedaliera di Perugia

Perugia, Italy

Location

Azienda Ospedaliera San Camillo Forlanini

Roma, Italy

Location

Fondazione Policlinico Universitario Campus Bio-Medico

Roma, Italy

Location

Ospedale Cristo Re

Roma, Italy

Location

Ospedale Isola Tiberina - Gemelli Isola

Roma, Italy

Location

San Carlo di Nancy

Roma, Italy

Location

Related Publications (3)

• Mari PV, Carriera L, Ricci A, Coppola A, Ielo S, D'Occhio A, Ibello AE, Ojetti V. Real-World Dupilumab in Type 2 Chronic Obstructive Pulmonary Disease (COPD): A Single-Centre Compassionate-Use Case Series. Biomedicines. 2026 Jun 23;14(7):1416. doi: 10.3390/biomedicines14071416.

  PMID: 42511891 BACKGROUND

• Bhatt SP, Rabe KF, Hanania NA, Vogelmeier CF, Bafadhel M, Christenson SA, Papi A, Singh D, Laws E, Patel N, Yancopoulos GD, Akinlade B, Maloney J, Lu X, Bauer D, Bansal A, Abdulai RM, Robinson LB; NOTUS Study Investigators. Dupilumab for COPD with Blood Eosinophil Evidence of Type 2 Inflammation. N Engl J Med. 2024 Jun 27;390(24):2274-2283. doi: 10.1056/NEJMoa2401304. Epub 2024 May 20.

  PMID: 38767614 BACKGROUND

• Bhatt SP, Rabe KF, Hanania NA, Vogelmeier CF, Cole J, Bafadhel M, Christenson SA, Papi A, Singh D, Laws E, Mannent LP, Patel N, Staudinger HW, Yancopoulos GD, Mortensen ER, Akinlade B, Maloney J, Lu X, Bauer D, Bansal A, Robinson LB, Abdulai RM; BOREAS Investigators. Dupilumab for COPD with Type 2 Inflammation Indicated by Eosinophil Counts. N Engl J Med. 2023 Jul 20;389(3):205-214. doi: 10.1056/NEJMoa2303951. Epub 2023 May 21.

  PMID: 37272521 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Eosinophilia

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Lorenzo Carriera

  Azienda Ospedaliera di Perugia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Department of Pulmonology and Sub-Intensive Respiratory Unit

Study Record Dates

• First Submitted: August 22, 2026
• First Posted: August 26, 2026
• Study Start: October 1, 2024
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (6)