We are studying a type of potential medicines called tri-specific.
They are thought to work by binding to and blocking three of the specific proteins that trigger inflammation in the airways and lungs that play a part in COPD.
We’re enrolling adults who have been diagnosed with COPD (Chronic Obstructive Pulmonary Disease).
COPD symptoms can vary and fluctuate over time. Periods of symptom worsening may represent exacerbations of COPD, often referred to as “flare-ups,” which can affect quality of life and may influence symptom progression over time.
Such ECOPD or flare-ups are usually triggered by factors such as viral or bacterial infections, smoke exposure, among others.
These flare-ups usually last from a few days to a few weeks and require additional therapy. Our mission is to bring patients treatments for COPD that may improve their lives.
Who may participate
This study may be an option if you:
- Are above the age of 35 with a diagnosis of COPD for at least 1 year
- Have a history of at least 2 COPD flare-ups in the past year
- Are a current or former smoker with more than 10 pack-years of smoking history e.g. at least one pack a day of cigarettes for 5 years, half a pack for 10 years or equivalent amount of cigarette smoking during your life
- Have no other major lung diseases such as asthma
- Have no other major health problems such as severe heart, kidney, or liver disease.
Condition
COPD
Age
35 to 80 years
Sex
Male or Female
Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.
What to expect
If this clinical trial is a good fit for you and you agree to take part, you will have a greater chance of you receiving one of the study medicines (67%) than a placebo (33%). A placebo does not have any medicine in it but looks just like the medicine being studied.
This clinical trial will last for approximately 68 weeks, and you may have up to 18 appointments in phase 2.
Whether you receive the study medicine or placebo, you may still take a standard of care medicine for COPD while participating in the clinical trial. This means you will be cared for using the current best practices determined by your study doctor.
Length of study treatment
Maximum duration Up to approximately 68 weeks or 16 months
Number of study visits
Up to 18 visits
Long-term follow up
About 12 weeks
About COPD
About COPD
COPD is a long-term respiratory condition that is often caused by underlying inflammation or damage to the lungs. People with COPD may experience symptoms such as shortness of breath, chronic coughing and fatigue.
These symptoms can vary over time and change in intensity. Symptoms are often triggered by factors such as smoking, allergens or irritants, change in weather or a viral or bacterial respiratory infection.
Some patients with moderate to severe COPD do not fully respond to current treatment options, and there is a need for more effective therapies to better control the symptoms and causes of COPD.
About the Study Medicine
About the Study Medicine
Frequently asked questions
What is COPD?
Chronic Obstructive Pulmonary Disease (COPD) is chronic respiratory disease. Common symptoms include shortness of breath or cough. Underlying inflammation has been found to be present in COPD patients. COPD is often divided in chronic bronchitis and emphysema phenotypes (how the patients express the disease clinically). People with COPD may experience coughing, shortness of breath, fatigue and sleep-related concerns such as poor sleep quality. COPD usually gets worse over time and is most often caused by smoking or long-term exposure to pollutants and other environmental factors.
What is a biologic?
Biologic medicines can target specific parts of your immune system. They are usually given as an injection and if you have a condition like COPD, they may help to reduce the inflammation in your body that triggers the symptoms associated with COPD.
What is a Tri-Specific?
Tri-Specific is a type of biologic medicine that can target three proteins in your immune system at the same time. They may help to reduce the underlying inflammation that plays a role in COPD flare-ups.
What do we mean by “moderate to very severe” COPD?
Moderate to severe COPD refers to the amount of lung function reduction compared to normal. It means you may have noticeable breathing problems during daily activities and may need medications like inhalers to manage your symptoms. People with moderate to severe COPD are also more likely to have flare-ups, called exacerbations, where symptoms suddenly get worse.
What are the chances of me receiving the study medicine?
In this clinical trial, there is a greater chance of you receiving one of the study medicines (67%) than a placebo (33%). A placebo does not have any medicine in it but looks just like the medicine being studied.
Is taking part in this clinical trial voluntary?
Yes, the decision to take part is entirely the participant’s choice. If you decide to participate, you will be free to stop taking part at any time and for any reason. A decision to stop being in the study will not affect your regular medical care or any benefits to which you are entitled.
How will participation affect future medical care?
Participation will not affect your regular medical care in the future. If you stop taking part, you may be asked to return to the clinic for an ‘end-of-study assessment’ then continue with the follow-up period. Participants with ongoing medical issues may be followed until the issue is resolved or medically stable.
Do participants have to pay to be in the study? Is health insurance needed to participate?
The study medicine and any study-related procedures are covered at no cost. Participants do not need health insurance to take part.
Is there travel support available for participants in this study?
You will be reimbursed for any reasonable expenses that you may have as a result of taking part in this study. This may include parking, meals, or other travel-related expenses.
Will my personal information be kept private?
All information collected from this study will be kept private and will not personally identify you. Security measures will be used to protect your data against accidental or unlawful loss, alteration, or unauthorized disclosure or access.
Why do we need clinical trials?
A clinical trial (or study) is a type of medical research in which people volunteer to take part. Clinical trials are the best way to investigate how potential medicines and other medical treatments affect patients. All medicines that become available today for use in people are first tested in studies involving hundreds to thousands of participants.
