An observational study in COPD (Chronic Obstructive Pulmonary Disease), COPD and Eosinophilia, sponsored by Azienda Ospedaliera di Perugia. Completed at 6 sites in Italy. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Azienda Ospedaliera di Perugia · Observational
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.
Design and setting. Retrospective, observational, multicentre cohort study conducted at six Italian respiratory and internal medicine centres: San Carlo di Nancy Hospital (GVM Care \& Research, Rome), Fondazione Policlinico Universitario Campus Bio-Medico (Rome), Azienda Ospedaliero-Universitaria Sant'Andrea (Sapienza University of Rome), Ospedale Cristo Re (Rome), Azienda Ospedaliera San Camillo-Forlanini (Rome) and Ospedale Isola Tiberina - Gemelli Isola (Rome). The study protocol (code PN002) was approved by the Comitato Etico Regionale Umbria on 20 May 2026. The study was conducted in accordance with the Declaration of Helsinki and is reported following the STROBE recommendations for observational research. Rationale. The BOREAS and NOTUS phase 3 trials established the efficacy of dupilumab in COPD with type 2 inflammation but restricted enrolment to a post-bronchodilator FEV1 between 30 and 70 percent predicted. Whether the functional response extends to patients outside that window has not been examined in a multicentre real-world cohort, and no published observational series has reported the response at the 12-week timepoint pre-specified in the registration trials.
Participants and treatment. Consecutive adults with a physician diagnosis of COPD who commenced dupilumab between October 2024 and April 2026 were considered. All received dupilumab 300 mg subcutaneously every two weeks as add-on therapy through the manufacturer's named-patient compassionate-use programme; background inhaled therapy was continued unchanged. Because compassionate-use access is typically requested for refractory disease and applies no ceiling on disease severity, the cohort is expected to be weighted towards the severe end of the type 2-inflamed COPD spectrum and should not be read as a representative sample of all candidates for biologic therapy.
Measurements. Spirometry was performed at each centre according to the American Thoracic Society and European Respiratory Society technical standards. All reported spirometric values are post-bronchodilator. Percent predicted values, z-scores and lower limits of normal were computed from the Global Lung Function Initiative 2012 equations for the Caucasian population. Airflow limitation was graded on post-bronchodilator FEV1 percent predicted using the Global Initiative for Chronic Obstructive Lung Disease thresholds. Symptom burden was quantified with the CAT and the mMRC dyspnoea scale. FeNO was measured before spirometry where locally available. Blood eosinophil counts were obtained from routine laboratory testing at the screening visit. Assessments were scheduled at baseline and at approximately 12 weeks, following local standard of care.
Analysis. Continuous variables are summarised as mean with standard deviation and as median with interquartile range; categorical variables as counts and percentages. Paired comparisons between baseline and 12 weeks were performed with the Wilcoxon signed-rank test, with the paired t-test reported alongside; 95 percent confidence intervals for mean differences were derived from the t distribution and standardised effect sizes are expressed as Cohen's dz. Two pre-specified analyses addressed generalisability and robustness: participants were classified as trial-eligible or trial-ineligible according to whether baseline post-bronchodilator FEV1 fell within the 30 to 70 percent predicted window, with between-group comparison by the Mann-Whitney U test; and heterogeneity across recruiting centres was assessed with the Kruskal-Wallis test and with a leave-one-centre-out sensitivity analysis. No imputation was performed for missing data; analyses used all available paired observations and the denominator is reported for every estimate.
Overlap with previous work. Twelve participants from one contributing centre were previously reported in a single-centre descriptive compassionate-use case series with a different analysis timepoint and a different set of endpoints. They are included here within the larger multicentre cohort, which addresses a distinct research question with a pre-specified primary variable.
Registration timing. This study was registered retrospectively, after completion of data collection
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's enrollment of 40 is below the median of 158 across 1,497 observational studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Azienda Ospedaliera di Perugia is the lead sponsor of 13 studies on the registry; 4 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
Time frame: Baseline and 12 weeks after the first dose of dupilumab
Change from baseline in post-bronchodilator FEV1 percent predicted at 12 weeks
Post-bronchodilator FEV1 expressed as a percentage of the predicted value derived from the Global Lung Function Initiative 2012 equations for the Caucasian population. Change is the value at 12 weeks minus the value at baseline.
Time frame: Baseline and 12 weeks
Change from baseline in post-bronchodilator FEV1 z-score at 12 weeks
Post-bronchodilator FEV1 expressed as a z-score derived from the Global Lung Function Initiative 2012 equations. Change is the value at 12 weeks minus the value at baseline.
Time frame: Baseline and 12 weeks
Change from baseline in post-bronchodilator forced vital capacity at 12 weeks
Post-bronchodilator forced vital capacity (FVC) measured in millilitres by spirometry. Change is the value at 12 weeks minus the value at baseline.
Time frame: Baseline and 12 weeks
Change from baseline in COPD Assessment Test total score at 12 weeks
The COPD Assessment Test (CAT) is an eight-item patient-completed questionnaire; each item is scored from 0 to 5 and the total score ranges from 0 to 40, with higher scores indicating greater symptom burden. Change is the total score at 12 weeks minus the total score at baseline.
Time frame: Baseline and 12 weeks
Number of participants with an increase in post-bronchodilator FEV1 of at least 100 mL at 12 weeks
Count of participants whose post-bronchodilator FEV1 at 12 weeks exceeds the baseline value by 100 mL or more. The threshold was defined a priori.
Time frame: Baseline and 12 weeks
Number of participants with a decrease in COPD Assessment Test total score of at least 2 points at 12 weeks
Count of participants whose CAT total score at 12 weeks is at least 2 points lower than at baseline, corresponding to the established minimal clinically important difference.
Time frame: Baseline and 12 weeks
Number of participants with a decrease in modified Medical Research Council dyspnoea grade of at least 1 grade at 12 weeks
Count of participants whose mMRC grade at 12 weeks is at least one grade lower than at baseline.
Time frame: Baseline and 12 weeks
Number of participants with baseline post-bronchodilator FEV1 outside the 30 to 70 percent predicted range
Count of participants whose baseline post-bronchodilator FEV1 percent predicted falls outside the 30 to 70 percent range that was required for entry into the BOREAS and NOTUS registration trials, reported separately for values below 30 percent and above 70 percent
Time frame: Baseline
Change from baseline in fractional exhaled nitric oxide at 12 weeks
Fractional exhaled nitric oxide (FeNO) measured in parts per billion before spirometry, at centres where the measurement was locally available. Change is the value at 12 weeks minus the value at baseline. This measure is exploratory and is available in a subset of participants.
Time frame: Baseline and 12 weeks
Number of participants who died during follow-up
Count of deaths from any cause recorded during follow-up, with the underlying cause reported.
Time frame: From the first dose of dupilumab and up to 24 weeks
Plan to share: No — Individual participant data are not planned to be made publicly available. De-identified data underlying the reported analyses may be made available from the corresponding author on reasonable request, subject to approval by the sponsor and by the ethics committee and to a data sharing agreement.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive →
Azienda Ospedaliera di Perugia