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Can a new injection breathe life into COPD treatment?

NCT ID NCT07788092

Disease control Sponsor: Azienda Ospedaliera di Perugia Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time

Summary

This study looks at whether dupilumab, an injectable medication, can improve lung function and reduce symptoms in adults with COPD who have a specific type of inflammation. The researchers are reviewing medical records from patients who received dupilumab as part of routine care, including those with varying degrees of airflow limitation. The main goal is to see how lung function changes after 12 weeks of treatment, and whether the effect differs based on the severity of the disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dupilumab (Dupixent), given as an injection under the skin every two weeks
What this could lead to
If successful, this could show that dupilumab helps improve lung function and ease symptoms in a broader range of COPD patients than previously studied, potentially expanding who might benefit from this treatment.
What could go wrong
This is a small, observational study, not a controlled trial, so results may be influenced by other factors. Also, dupilumab may not work equally well for everyone, and there are potential side effects like injection reactions or increased risk of infections.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

40 people

The number who actually took part.

Started

Oct 2024

Finished

Apr 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease COPD, severe early onset Eosinophilia hypereosinophilic syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

COPD COPD, chronic obstructive pulmonary disease Eosinophilia

Contacts and locations

Locations

  • Azienda Ospedaliera San Camillo Forlanini

    Roma, Italy

  • Azienda Ospedaliera di Perugia

    Perugia, Italy

  • Fondazione Policlinico Universitario Campus Bio-Medico

    Roma, Italy

  • Ospedale Cristo Re

    Roma, Italy

  • Ospedale Isola Tiberina - Gemelli Isola

    Roma, Italy

  • San Carlo di Nancy

    Roma, Italy

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