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RecruitingPHASE4INTERVENTIONAL

A Study to Investigate Airway Inflammation With Dupilumab Subcutaneously in Participants Aged ≥40 to ≤85 Years With Chronic Obstructive Pulmonary Disease.

This study is testing a new medication called dupilumab for people between 40 and 85 years old who have moderate to severe Chronic Obstructive Pulmonary Disease (COPD). Researchers want to find out if dupilumab can help reduce inflammation in the airways, improve lung function, and make breathing easier. They also want to see if it helps prevent flare-ups and improves overall quality of life. Half the participants will receive dupilumab, and the other half will receive a dummy treatment (placebo). The study will last up to 40 weeks, with the treatment given for up to 24 weeks, and involve 9 visits to the clinic.

At a glance

Status
Recruiting
Phase
PHASE4
Sponsor
Sanofi
Enrolment target
218
Start
22 Sep 2025
Estimated completion
02 Feb 2029

What is this study about?

This research study is specifically for individuals aged 40 to 85 who have been diagnosed with Chronic Obstructive Pulmonary Disease, often called COPD. COPD is a long-term lung condition that makes it hard to breathe because the airways in the lungs become inflamed and narrowed. The main goal of this study is to explore whether a new medication, dupilumab, can help reduce this inflammation. Researchers believe that by reducing inflammation, it could lead to better breathing, fewer sudden worsening of symptoms (called exacerbations), and an improved quality of life for people living with COPD.

In this study, some people will receive the new medication, dupilumab, while others will receive a 'placebo', which looks identical but contains no active medicine. This allows doctors to accurately compare the effects of the treatment. They will be looking closely at how dupilumab affects the air passages, including any changes in how swollen they are, how easily air flows through them, and whether it reduces issues like mucus buildup. They also want to understand if these changes lead to real benefits like better lung function and overall well-being.

This is a 'Phase 4' study, which means the treatment has already undergone earlier testing. Doctors are now trying to understand more about its specific effects on COPD, particularly concerning inflammation in the airways. If successful, this research could pave the way for new treatment options to help manage COPD symptoms and improve the lives of those affected.

Key takeaways

  • This study is for people aged 40-85 with moderate-to-severe COPD.
  • It tests a new drug, dupilumab, to see if it reduces lung inflammation.
  • Participation involves 9 visits over up to 40 weeks.
  • You might receive dupilumab or a dummy medication (placebo).
  • Specific criteria exist for who can and cannot join.
  • You can stop participating at any time.

Who may be eligible?

To be considered for this study, you need a confirmed diagnosis of COPD from your doctor. You must be a current or past smoker with a history of smoking for at least 10 years, and your COPD should be considered moderate to severe. Your breathing difficulties should also be significant enough to affect your daily life.

Drs are also looking for specific signs of inflammation in your blood called 'Type 2 inflammation,' which is measured by certain blood cells (eosinophils). Your current COPD treatment should include a combination of three types of medicines for at least three months, or two if one is not suitable for you. You cannot have asthma or other major lung diseases, such as lung scarring or severe high blood pressure in the lungs. You also can't be on very high levels of oxygen at home or have had a lung infection recently.

You also won't be able to join if you're already taking certain biological treatments for your lung condition, including any experimental drugs or dupilumab. If you take medicines to thin mucus, you need to have been on a stable dose for more than six months. The study is very specific about who can take part to ensure safety and that the results are as clear as possible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Do I have a doctor's diagnosis of COPD?
  2. Am I between 40 and 85 years old?
  3. Have I smoked for at least 10 years (past or present)?
  4. Is my COPD considered moderate to severe?
  5. Am I currently on a combination of 2 or 3 COPD medications?
  6. Do I have certain markers of 'Type 2 inflammation' in my blood?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would visit the clinic 9 times over a maximum period of 40 weeks, which is about 9-10 months. The actual study medication (either dupilumab or a dummy treatment) would be given to you for up to 24 weeks, which is about 5-6 months. During your visits, doctors and nurses would perform various checks, which might include breathing tests, blood samples, and symptom questionnaires. You would receive the study medication regularly, likely by injection under the skin, as directed by the study team. You would also continue your regular COPD medications unless advised otherwise by the study doctor.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as receiving a new investigational treatment that might help your COPD symptoms, or getting closer monitoring of your health. However, there are also potential risks involved, including side effects from the study medication, discomfort from tests like blood draws, or the treatment not being effective for you. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (61)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • University of Alabama at Birmingham - School of Medicine- Site Number : 8400003
    Verified postcode
    Birmingham, United States· Recruiting
  • Finlay Medical Research- Site Number : 8400010
    Verified postcode
    Miami, United States· Recruiting
  • Private Practice - Dr. David Kavtaradze- Site Number : 8400017
    Verified postcode
    Cordele, United States· Recruiting
  • Johns Hopkins Bayview Medical Center- Site Number : 8400009
    Verified postcode
    Baltimore, United States· Recruiting
  • Brigham & Women's Hospital- Site Number : 8400014
    Verified postcode
    Boston, United States· Recruiting
  • American Health Research - Charlotte- Site Number : 8400013
    Verified postcode
    Charlotte, United States· Recruiting
  • Atrium Health Wake Forest Baptist Pulmonary, Sleep And Allergy- Site Number : 8400004
    Verified postcode
    Winston-Salem, United States· Recruiting
  • Clinical Research Associates of Central Pennsylvania- Site Number : 8400002
    Verified postcode
    DuBois, United States· Recruiting
  • REX Clinical Trials - Beaumont- Site Number : 8400011
    Verified postcode
    Beaumont, United States· Recruiting
  • Investigational Site Number : 0320001
    Verified postcode
    San Miguel de Tucumán, Argentina· Recruiting
  • Investigational Site Number : 0320002
    Verified postcode
    Buenos Aires, Argentina· Recruiting
  • Investigational Site Number : 0320003
    Verified postcode
    Buenos Aires, Argentina· Recruiting

Common questions

What is COPD?

COPD stands for Chronic Obstructive Pulmonary Disease. It's a long-term lung condition that makes it hard to breathe, often caused by smoking, leading to inflammation and narrowing of the airways.

What is dupilumab?

Dupilumab is a medication being tested to see if it can help reduce inflammation in the airways of people with COPD.

Will I know if I'm getting the real medicine or the dummy treatment?

No, this is a 'blinded' study, meaning neither you nor the study doctors will know if you're receiving dupilumab or the placebo until the study is over.

How long will I be in the study?

The maximum time you would be involved in the study is about 40 weeks, with up to 24 weeks of receiving the treatment.

Can I leave the study at any time?

Yes, you can choose to leave the study at any point, and your decision will not affect your ongoing medical care.

How to find out more

Trial Transparency email recommended (Toll free for US & Canada)

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Study to Investigate Airway Inflammation With Dupilumab Su…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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