Study of dupilumab injections to reduce airway inflammation in adults aged 40-85 with chronic obstructive pulmonary disease

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What is this study about?

This study focuses on patients with Chronic Obstructive Pulmonary Disease (COPD), a long-term lung condition that causes breathing difficulties. The research examines the effects of dupilumab, given as an injection under the skin, compared to a placebo. The purpose is to evaluate how this medication affects inflammation in the airways, particularly looking at mucus buildup in the lungs.

The study involves patients who have moderate to severe COPD and show specific signs of inflammation in their blood. During the study, participants receive either dupilumab (also known as SAR231893) or a matching placebo as injections under the skin for 24 weeks. The medication is provided in pre-filled syringes, and participants continue taking their regular COPD medications throughout the study.

The research uses special lung imaging techniques to examine how the treatment affects mucus in the airways. High-resolution Computed Tomography (HRCT) scans are used to look at changes in the lungs over the course of treatment. The study also monitors the safety of the treatment and any changes in breathing ability.

1 Initial assessment

You will undergo an evaluation to confirm your eligibility for the study, including verification of chronic obstructive pulmonary disease (COPD) diagnosis

Your medical history will be reviewed, including smoking history of at least 10 pack-years

Blood tests will be performed to check your eosinophil levels (type of white blood cells)

A high-resolution computed tomography (HRCT) scan will be performed to assess mucus in your lungs

2 Treatment assignment

You will be randomly assigned to receive either dupilumab or placebo

The medication will be provided as an injection under the skin (subcutaneous use)

You will continue your regular COPD medications throughout the study

3 Treatment period

The treatment period will last 24 weeks

You will receive regular injections of either dupilumab or placebo

Your current COPD medications will continue, including triple therapy (three different types of inhaled medications) or dual therapy if needed

4 Monitoring and assessments

Regular tests will be performed to measure your lung function

You will undergo forced oscillation technique (FOT) tests to measure airway resistance

Additional HRCT scans will be performed to track changes in mucus levels and airway wall thickness

Any side effects or health changes will be monitored and recorded throughout the study

5 Final evaluation

At week 24, final assessments will be performed

These will include HRCT scans, lung function tests, and blood tests

The results will be compared to your initial measurements to evaluate the treatment effects

Who Can Join the Study?

Must be a current or former smoker with a history of smoking at least 10 pack-years (equivalent to smoking 1 pack of cigarettes per day for 10 years)
Must have moderate-to-severe breathing condition with specific lung function test results showing:
- Reduced breathing capacity after using bronchodilator medication
- Lung function between 30% and 70% of normal predicted values
Must have either:
- Significant breathlessness (grade 2 or higher on breathing difficulty scale), or
- Score of 10 or higher on COPD assessment test measuring daily symptoms
Must have frequent or severe episodes of symptom worsening
Must be using three types of inhaled medications for at least 3 months, with stable dosing for at least 1 month before study start (or two types if unable to use inhaled steroids)
Must have elevated levels of specific white blood cells (eosinophils) showing either:
- 300 or more cells per microliter at screening, or
- 150 or more cells per microliter at screening with previous history of 300 or more cells in the past year
Must have a mucus score of 3 or higher on medical imaging
Must be an adult (18 years or older)
Can be either male or female

Who Cannot Join the Study?

Previous participation in a clinical trial involving dupilumab (an injectable medication for treating certain inflammatory conditions)
Having any serious or active infections, including tuberculosis or hepatitis B
History of severe allergic reactions to injectable medications
Current pregnancy or breastfeeding
Significant liver or kidney disease
Active cancer or cancer treatment within the past 5 years
Use of other biologic medications (specialized drugs that target specific parts of the immune system) within the past 4 months
Uncontrolled heart disease or high blood pressure
History of drug or alcohol abuse within the past year
Mental health conditions that could interfere with study participation
Any condition that, in the opinion of the study doctor, would make participation unsafe
Unable or unwilling to undergo required HRCT scans (detailed X-ray imaging of the chest)
Unable to follow study procedures or attend scheduled visits

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Lille	Lille	France
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
Medizinische Universitaet Innsbruck	Innsbruck	Austria
CHU Grenoble Alpes	La Tronche	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France

Other Sites

Site Name	City	Country
Karolinska University Hospital	Solna	Sweden
Sygehus Lillebaelt Vejle Sygehus	Vejle	Denmark
Hopital Beaujon	Clichy	France
Alergologia Plus Sp. z o.o.	Poznan	Poland
Canisius Wilhelmina Ziekenhuis	Nijmegen	The Netherlands
Ukhfgljujo Of Dmteirdv	Debrecen	Hungary
Vsessnwz Cfocbfko Rvngrizn Lytffuw Gbxn	Luebeck	Germany
Pbuacp Ruwqtwblkqj Hgabgh Swgt	Barcelona	Spain
Aaxlxrwiuf Pzvckquc Hcmtdqqn Dh Mwktebmqk	Marseille	France
Ryjnar Sbewr Soilye Uxnisonvzejlgvanrrt	Lund	Sweden
Skdezogzm Rwumbgn Ukrsjgbmjy Mfganrr Chtsrc	Nijmegen	The Netherlands
Hsljinsq Uctwgvxluaenb Fxjcwfimx Jjstfvh Duti	Madrid	Spain
Cyeyte Hhlsvzhvjxu Utxamkryzpbod Dh Meyvkjgcrkh	Montpellier	France
Acmhaau Uycuvicjeb Hxqlddty	Aalborg	Denmark
Kpcbsh Ubvktllulccimzjaxbnov Gzqi	Linz	Austria
Uvdpttunfttz Mhfwpkf Cxadwkh Gwchyhkbh	Groningen	The Netherlands
Cmqebc Hiqlyzgxytu Lipa Sib	Pierre Benite	France
Hijwmeap Ufobmeouksbji Mgfdsiu Db Vxcbnuptdl	Santander	Spain
Uprbogzcvglnuvlcz Dsvlv Sqbqa Do Fglttiy	Ferrara	Italy
Qlhoh Sbgqta Ctakvfndy Hxmuhlfk &oktmiw Sezhtecjihx Uvoppwmabc Hooqktjc &eeszok Vtphxgm Gzfigbgivfyxixldvd	Gothenburg	Sweden
Snshu Wqic Wbvcgu Gsmgtayiwoxzyybzxj	Vienna	Austria
Ccktiol Mkqavgvv Ojsrzztowh Mytg Shk jo	Bialystok	Poland
Ias Peyhxikgqau Gzrk &xxye Cvz Ko	Frankfurt	Germany
Iwuzbaxhb Knfk	Pecs	Hungary
Cjavzevtv Krrq	Hajdunanas	Hungary
Ahyrzzh Owwemkgwnxlyxtgocalybrwkp Sli Lgroj Ggjukux	Orbassano	Italy
Aakwssn Okpgxdkegpk Ugiidulndtmev Suvxgx	Siena	Italy
Hwehvdet Urlbazuuzueqj Qmrhwletihi Mvtgmy	Pozuelo De Alarcon	Spain
Sfey Fdjppigsmj Vmpyiqghk Gxgcf Syadbqrsd	Rotterdam	The Netherlands
Ciuzsn Hckiqxqensc Uylqfeoyfqope Rqzcz	Reims	France
Agmkudy Uvlzmdtswkqk Lepzfo Svllc Smxcffnvb Nb 2 Mlkrr Tvugmxfodg	Treviso	Italy
Ogjpivmifswn Cpvxeer Mlvqzevj Ahsp Owqeh Cdlhsg Kalhgwtdz Cooiat soso	Ostrowiec Swietokrzyski	Poland
Suuimmd Gkwqfuxe	Hoofddorp	The Netherlands
Itosydel fqi Aqjfnmzr uzc Apuyyefexxuaqbv Bbjqmd	Berlin	Germany

Trial status

Country	Status	Recruitment Start
Austria	Not yet recruiting	01.10.2025
Denmark	Recruiting	01.10.2025
France	Recruiting	01.10.2025
Germany	Not yet recruiting	01.10.2025
Hungary	Recruiting	01.10.2025
Italy	Recruiting	01.10.2025
Poland	Recruiting	01.10.2025
Spain	Recruiting	01.10.2025
Sweden	Not yet recruiting	01.10.2025
The Netherlands	Recruiting	01.10.2025

Trial locations

Investigated Drugs:

Dupilumab is a medication used to treat inflammation in the airways. It works by blocking certain proteins in the body that cause inflammation. In this trial, it is being studied for its effects on reducing mucus plugging in the lungs of patients with chronic obstructive pulmonary disease (COPD). The medication helps decrease inflammation in the airways and may improve breathing by reducing the amount of mucus that builds up in the lungs.

Respiratory tract disease – A condition affecting the airways and other structures of the respiratory system, from the nasal passages to the lungs. It involves the accumulation of mucus in the airways, which can lead to breathing difficulties. The condition can cause changes in airway wall thickness and affect normal respiratory function. Respiratory tract disease often involves increased airway resistance and changes in lung tissue that can be observed through medical imaging. The condition may be characterized by ongoing inflammation of the respiratory passages.

Trial ID:

2025-521268-37-00

Protocol code:

LPS18583

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of dupilumab injections to reduce airway inflammation in adults aged 40-85 with chronic obstructive pulmonary disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?