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Check your eligibility now & get in touch with a study center
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CHECK ELIGIBILITYIs COPD disrupting your daily life?
If you or a loved one have Chronic Obstructive Pulmonary Disease (COPD), you may be interested in learning more about the PERSEPHONE and THESEUS clinical studies.
Short Summary
Medical Condition:
Chronic Obstructive Pulmonary Disease (COPD)
Participation duration:
Approximately 14 months
Phase:
2b/3
What is Chronic Obstructive Pulmonary Disease (COPD)?
Chronic Obstructive Pulmonary Disease, commonly known as “COPD,” is a lung disease that is usually diagnosed using special breathing tests that measure how well your lungs are working. People with COPD often experience shortness of breath, frequent coughing, tiredness, wheezing, and produce excess mucus. Everyday activities such as walking, cooking, or doing housework can become tiring. COPD usually starts after years of damage to the lungs, often from smoking or breathing in air pollution.
There are two main parts of the disease:
- Flare-ups - times when symptoms suddenly worsen, often triggered by infections and sometimes requiring hospitalisation.
- Slow loss of lung strength over time and breathing gradually becoming more difficult.
Managing COPD involves treating symptoms, preventing flare-ups, and slowing the progression of the disease.
Find out if a COPD clinical study might be a match for you.
Please answer a few questions to see if you may qualify for a clinical study.
With your consent, we (Trialbee) will collect and use the information you submit here to indicate your interest in participating in a clinical study, and to see if you are eligible to move to the next stage of screening.
During the next stage, you will be contacted by Trialbee to ask some additional questions to further assess your eligibility and discuss clinical study participation.
What are the PERSEPHONE and THESEUS clinical studies?
PERSEPHONE and THESEUS are two clinical studies that are testing the same investigational study medicinal product. The investigational study medicinal product is a type of medicine that works by targeting specific pathways of inflammation related to some COPD symptoms. The main objectives of these two studies is to learn how the investigational study medicinal product impacts:
- COPD flare-ups (or exacerbations)
- Lung function
- Quality of life
These clinical studies are investigating how well the investigational study medicinal product works for patients with moderate to severe COPD and who are either current smokers or have a history of smoking.
The PERSEPHONE and THESEUS clinical studies are randomised, double-blind, placebo-controlled clinical studies. In these studies, two medicinal product dose regimens are tested. This has no impact on your study visit schedule, but it means that you have a 2 out of 3 chance of receiving the investigational study medicinal product, and a 1 out of 3 chance of receiving placebo.
- Randomisation means that a computer will randomly assign participants to receive either the investigational study medicinal product or placebo.
- Double-blind means that neither you nor your study doctor will know whether you are receiving the investigational study medicinal product or placebo.
- The placebo looks like the investigational study medicinal product but does not contain any active medication.
The investigational study medicinal product is not approved by health authorities such as the Medicines and Healthcare products Regulatory Agency (MHRA) and is still under investigation for the treatment of COPD, so its effectiveness and safety have not been established.
Who can participate?
You may be eligible* to participate if you:
Are between the ages of 40 – 80 years old
Have had a diagnosis of COPD for at least 1 year
Are a current or former smoker
Have had at least 2 COPD flare-ups in the last year, or have been hospitalised in the last year for a COPD flare-up
Are taking daily treatments for your COPD
*Please note there are more eligibility criteria that must be met to be considered for participation.
What happens if I participate?
The clinical studies are divided into periods:
Screening Period
(typically between 2 and 4 weeks – [1 study site visit])
The study doctor and team at the study site will assess your eligibility for one of the clinical studies, and the decision to participate will be yours to make. Once specific tests and assessments are completed, and you meet all the required criteria for participation, the treatment period of the clinical study will begin. Throughout your participation, you will also be asked to use an electronic diary (e-diary) once a day to answer a few simple questions about your health and to record the COPD medicines you actually took. Your e-diary will be reviewed with the study team during your study site visits.
Study Treatment Period
(48 weeks – [14 study site visits])
During this period, you will receive either the investigational study medicinal product, or a placebo. A placebo will look like the investigational study medicinal product but does not contain any active medications. Both the investigational study medicinal product and placebo will be administered as a subcutaneous (under the skin) injection. The study team will provide you with information regarding the likelihood of which one you will receive. Neither you nor the study team will know whether you are taking the investigational study medicinal product or placebo during the study treatment period. The study treatment period will last 48 weeks and will require 14 visits to the study site. During your visits to the study site, you will receive your injection and undergo additional tests, including blood draws, smoking status checks, and breathing tests conducted by the study team. The study doctor and team will monitor your progress closely.
Follow up Period
(8 weeks – [1 study site visit])
Eight weeks after the Study Treatment Period ends, you will go back to see the study doctor for a safety check-up.
Your study doctor will be able to provide more detailed information on what will happen if you decide to participate.
How do I take part?
- Complete the online questions to see if you pre-qualify.
- Submit your contact information.
- Answer our phone call to answer more questions to help us determine if you are eligible.
- Confirm your interest and preferred study site location.
- Speak with the study site about the next steps to participate.
Frequently Asked Questions:
What will happen after I complete the online questionnaire?
What will happen after I complete the online questionnaire?
Should your online questionnaire suggest that you are potentially eligible, a qualified medical professional will contact you to conduct a more comprehensive telephone medical assessment and further evaluate your eligibility. Upon confirmation of your potential eligibility during the telephone medical assessment, you will be presented with nearby study sites conducting one of the clinical studies. The study site of your choice will be provided with your contact details in order to schedule an appointment to share more information about the clinical studies and learn about your medical history.
Where can I find more information about the PERSEPHONE and THESEUS clinical studies?
Where can I find more information about the PERSEPHONE and THESEUS clinical studies?
If you are interested in learning more about these clinical studies, we encourage you to complete the questions on the pre-screener to help assess if one of the clinical studies could be a match. You can then be referred to a study site in your area for answering all your questions.
What type of study-related medical care is provided during the clinical studies?
What type of study-related medical care is provided during the clinical studies?
Any medical care, tests or procedures that are for the purpose of these clinical studies will be provided and will be explained by the study site. As you will need to visit the study site throughout the duration of the study you are participating in, travel reimbursement will be available.
Why are clinical studies important?
Why are clinical studies important?
Clinical studies add to medical knowledge and help to bring new potential treatments to patients with medical conditions. To bring new treatments to the public, they need to be assessed in clinical studies, to determine if they work and are safe.
Clinical studies rely on the participation of volunteers. It can take several years for a new potential treatment to reach the public. Often, this timeline is due to how long it takes to complete a clinical study.
All approved prescription medicinal products have gone through clinical studies to assess their safety and efficacy and to understand what side effects may be involved.
Who runs clinical studies?
Who runs clinical studies?
Clinical studies can be sponsored, or funded, by pharmaceutical or biotechnology companies, academic medical centres, voluntary groups, or health care providers. These clinical studies are funded by AVENTIS PHARMA LIMITED a pharmaceutical company.
Every study site is led by a principal investigator, who is usually a medical doctor. Clinical studies also have a research team, which may include doctors, nurses, and other health care professionals. An independent committee of people from outside the study sponsor, called an Ethics Committee, reviews and monitors clinical studies to ensure that the rights and welfare of clinical study participants are protected.
What are the phases of clinical studies?
What are the phases of clinical studies?
Clinical studies are conducted in different phases.
Phase 1: After researchers have investigated the investigational study medicinal product in laboratory tests to assess its efficacy and ensure that it is safe to test in humans, the Phase 1 study is carried out to test the investigational study medicinal product in a small group of patients for the first time. This is done to evaluate its safety, determine a safe dosage range and identify potential side effects. The investigational study medicinal product is referred to as an investigational study medicinal product since it is under investigation and not yet approved by health authorities for use outside clinical studies.
Phase 2: the investigational study medicinal product is given to a larger group of patients (compared to Phase 1) to see if it is effective and to further evaluate its safety.
Phase 3: the investigational study medicinal product is given to large groups of patients to confirm its efficacy, monitor side effects, compare it to commonly used treatments or placebo, and collect information that will allow assessment of the investigational study medicinal product ’s safety.
What is a “placebo”?
What is a “placebo”?
Placebo is a term used to describe something that looks like the investigational study medicinal product but does not contain any active ingredients. A placebo is needed in a clinical trial so researchers can compare results and see if the treatment works better than no treatment at all.
Version 1.0. Approved 10/2025