AuthorisedTherapeutic exploratory (Phase II)Interventional

A Randomized, Double-Blind, Placebo-controlled, Parallel Arm, 52-week Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of Two Doses of EXPD-101 in Participants with COPD

Chronic obstructive pulmonary disease (COPD) causes long-term lung damage, breathlessness, and sudden flare-ups that can lead to hospital visits. This study is testing an experimental drug called EXPD-101 to see if it can prevent these flare-ups and improve quality of life over one full year. Participants will be placed by chance into one of three groups: a higher dose of EXPD-101, a lower dose, or an inactive dummy treatment called a placebo. Neither the participants nor the research doctors will know who is getting which treatment. Over 52 weeks, the medical team will track lung function, daily symptoms, blood levels of the drug, and general safety using routine checks such as heart traces and breathing tests. Taking part is entirely voluntary, and participants can leave the study at any time without it affecting their normal NHS care.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Expedition Therapeutics Inc.

Enrolment target

183

Start

29 Sep 2026

Chronic Obstructive Pulmonary Disease (COPD) exacerbations

What is this study about?

Chronic obstructive pulmonary disease, commonly known as COPD, is a long-term condition that causes inflammation in the lungs and narrows the airways. Many people with COPD experience sudden episodes where their symptoms become much worse, known as flare-ups or exacerbations. These flare-ups can be frightening, make everyday tasks exhausting, and often require urgent medical care or a stay in hospital.

This clinical trial is evaluating a new experimental treatment known as EXPD-101. The main goal is to find out whether taking this medicine over a 52-week period reduces the number and severity of chest flare-ups. Researchers also want to check how the body handles the medicine, whether it eases day-to-day breathlessness, and if it helps improve general wellbeing and lung strength.

Finding new ways to prevent flare-ups is vital for people living with COPD. If EXPD-101 proves to be safe and effective, it could offer a valuable new treatment option in the future, helping patients breathe more easily and spend less time in hospital.

Key takeaways

The trial tests an experimental medicine called EXPD-101 to see if it reduces COPD flare-ups.
Participation lasts for 52 weeks (one year) and includes regular clinic check-ups.
You will be randomly assigned to receive EXPD-101 or an inactive placebo dummy treatment.
The study includes detailed breathing tests, heart checks, and quality-of-life surveys.
Joining is completely voluntary, and you can withdraw at any time without losing your usual care.

Who may be eligible?

This study is open to men and women aged 18 and older who have been diagnosed with chronic obstructive pulmonary disease (COPD). Because the trial focuses on preventing flare-ups, doctors will look for people whose COPD has caused noticeable breathing troubles or chest episodes in the past.

To make sure taking part is safe, the study team will carry out health checks before you join. People who have certain other serious medical conditions, such as severe heart problems or other major lung diseases, may not be able to join. The researchers will also review any regular medicines you take to make sure they are safe to use alongside the study drug.

Your study doctor will carefully go through the complete list of requirements with you to decide whether this trial is a suitable and safe match for your personal health needs.

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.

I am aged 18 or older.
I have a confirmed medical diagnosis of COPD.
I have experienced chest flare-ups or worsening breathing symptoms.
I am able and willing to attend regular hospital or clinic appointments over 52 weeks.
I am happy to undergo routine tests such as blood tests, heart traces, and breathing checks.

Answer every question to see your result.

What does participation involve?

Taking part in this study lasts for about one year (52 weeks). During this time, you will take either the study drug (EXPD-101 at one of two doses) or an inactive dummy treatment (placebo). You will need to attend regular clinic visits so the medical team can closely monitor your health. These visits will include routine breathing checks (spirometry tests where you blow into a tube), blood tests, heart traces (ECGs), physical examinations, and occasional phlegm (sputum) samples. You will also be asked to fill in short questionnaires about your energy levels, coughing, and daily breathing symptoms. The study team will provide 24-hour contact details in case you feel unwell between visits.

Potential risks and benefits

A potential benefit of joining is that the study medicine may help reduce your chest flare-ups and ease your breathing, although this cannot be guaranteed. You will also receive comprehensive, regular lung health checks from specialist doctors. However, as with any experimental drug, there is a risk of side effects, and you might receive the placebo rather than the active medicine. Clinic visits and breathing tests will also require a commitment of your time. Taking part is completely voluntary, and you are free to leave the study at any point without giving a reason and without any impact on your standard NHS healthcare.

Locations (9)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy
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Unverified
Germany
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Unverified
Spain
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Unverified
Poland
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Unverified
Czechia
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Unverified
Romania
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Unverified
Hungary
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Unverified
Denmark
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Unverified
Bulgaria

Common questions

What is a placebo and why is it used?

A placebo looks just like the real medicine but contains no active ingredients. It helps scientists prove whether any improvements or side effects are truly caused by EXPD-101 rather than chance.

Can I carry on using my regular COPD inhalers?

In most cases, you can continue taking your usual rescue or maintenance inhalers, but the study doctor will check all your current medicines to ensure they are safe to use during the trial.

Will taking part cost me anything?

No. The study medication, clinic tests, and doctor visits are provided free of charge. Most trials also offer help to cover reasonable travel expenses to and from the clinic.

What happens if I have a severe flare-up during the trial?

Your safety comes first. The study team will give you a clear action plan, and you will receive standard medical treatment straight away, which may include antibiotics, steroids, or hospital care if needed.

Can I leave the study if I change my mind?

Yes. You have the right to withdraw from the trial at any time, for any reason. Doing so will not affect your relationship with your doctors or your future NHS care.