COPD (Chronic Obstructive Pulmonary Disease)DUPICENTRONCT07788092
Dupilumab in Type 2-Inflamed COPD Across the Full Spectrum of Airflow Limitation: An Italian Multicentre Retrospective Cohort Study
An observational study of COPD (Chronic Obstructive Pulmonary Disease) and COPD, run by Azienda Ospedaliera di Perugia at 6 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease), COPD, Eosinophilia
- What is being tested?
- Dupilumab
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 6 sitesItaly
- Study dates
- 1 Oct 2024to 30 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Italy6 sites
Azienda Ospedaliera di Perugia
Perugia
Azienda Ospedaliera San Camillo Forlanini
Roma
Fondazione Policlinico Universitario Campus Bio-Medico
Roma
Ospedale Cristo Re
Roma
Ospedale Isola Tiberina - Gemelli Isola
Roma
San Carlo di Nancy
Roma
About this study
Official title: Real-World Lung Function and Symptom Response to Dupilumab in Type 2-Inflamed Chronic Obstructive Pulmonary Disease Across the Full Spectrum of Airflow Limitation: An Italian Multicentre Retrospective Cohort Study
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.
Read the detailed description
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
- Being tested
- Dupilumab
- Keywords
- dupilumab, biologic therapy, eosinophilic COPD, Type 2 Inflammation, Eosinophils, FEV1, compassionate use, Real-World Evidence
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Eosinophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabDrug
Also called Dupixent
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Dupilumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start1 Oct 2024
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera di Perugia
- Sponsor type
- University, hospital or other
- Collaborators
- Ospedale San Carlo di Nancy, Roma, Campus Bio-Medico University, S. Andrea Hospital, Azienda Ospedaliera San Camillo Forlanini, Isola Tiberina - Gemelli Isola Hospital, Rome, Italy, Ospedale Cristo Re - Roma
- Responsible party
- Principal investigator, Lorenzo Carriera, Azienda Ospedaliera di Perugia
- Investigators
- Lorenzo Carriera, Principal investigator, Azienda Ospedaliera di Perugia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788092
- Sponsor's protocol ID
- PN002
- Other IDs
- Comitato Etico Regione Umbria
- Acronym
- DUPICENTRO
- Status last verified
- Aug 2026
- First submitted
- 22 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 42511891Bhatt 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.
PubMed 38767614Bhatt 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.
PubMed 37272521
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Lung Function and Symptom Response to Dupilumab in Type 2-Inflamed Chronic Obstructive Pulmonary Disease Across the Full Spectrum of Airflow Limitation: An Italian Multicentre Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07788092
- Acronym / sponsor ID
- DUPICENTRO / PN002
- Keywords
- dupilumab, biologic therapy, eosinophilic COPD, Type 2 Inflammation, Eosinophils, FEV1, compassionate use, Real-World Evidence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Azienda Ospedaliera di PerugiaUniversity, hospital or other
- Collaborators
- Ospedale San Carlo di Nancy, Roma, Campus Bio-Medico University, S. Andrea Hospital, Azienda Ospedaliera San Camillo Forlanini, Isola Tiberina - Gemelli Isola Hospital, Rome, Italy, Ospedale Cristo Re - Roma
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 2-inflamed COPD treated with dupilumab | – | Drug: DupilumabConsecutive 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DupilumabAlso: DupixentDupilumab 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 | Drug | Type 2-inflamed COPD treated with dupilumab |
Primary outcome
Change from baseline in post-bronchodilator FEV1 at 12 weeks
Time frame: Baseline and 12 weeks after the first dose of dupilumab
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.
7 secondary outcomes
Change from baseline in post-bronchodilator FEV1 percent predicted at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline in post-bronchodilator FEV1 z-score at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline in post-bronchodilator forced vital capacity at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline in COPD Assessment Test total score at 12 weeks
Time frame: Baseline and 12 weeks
Number of participants with an increase in post-bronchodilator FEV1 of at least 100 mL at 12 weeks
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
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
Time frame: Baseline and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Background: PubMed 42511891Mari 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.
- Background: PubMed 38767614Bhatt 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.
- Background: PubMed 37272521Bhatt 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.
- Individual participant dataSharing planned: 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.
Related trials for COPD (Chronic Obstructive Pulmonary Disease)
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorenzo Carriera principal investigator
Azienda Ospedaliera di Perugia
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD (Chronic Obstructive Pulmonary Disease) and COPD, run by Azienda Ospedaliera di Perugia at 6 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in post-bronchodilator FEV1 at 12 weeks (time frame: Baseline and 12 weeks after the first dose of dupilumab). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07788092, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.