About Moderate-to-Severe Asthma
Moderate-to-Severe Asthma is a common inflammatory disease that affects the airways and lungs. Inflammation and constriction of the airways of the lung can result in limitation of daily activities, decreased quality of life, A&E visits, inpatient admission, and even death.
Asthma can cause difficulty breathing, wheezing, coughing, and difficulty sleeping.
Asthma is a chronic condition and affects up to 262 million people worldwide. Multiple treatment options are available that can ease symptoms.
What is the AIRCULES study?
Researchers at select research centres are looking for people between 18 to 80 years old, who have had a diagnosis of moderate-to-severe asthma for at least the past 12 months. The goal of the AIRCULES study is to learn more about the investigational study medicinal product, and whether it may improve the symptoms of people suffering with moderate-to-severe Asthma, as well as its associated safety and tolerability. The investigational study medicinal product, is given as an injection under the skin (also called subcutaneously) and is investigational, meaning that it has not been fully tested and has not yet been approved by any health authority, except for use in clinical research studies such as this one. 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 asthma, so its effectiveness and safety have not been established.
The study is a randomised study, meaning that participants are randomly assigned (like tossing a coin) to one of two groups. One group is given the investigational study medicinal product and the other group is given a placebo. A placebo looks like the investigational study medicinal product, but contains no active ingredients. The study is double-blind, so neither participants nor study doctors will know which group you are placed in. Both groups are followed equally by the study doctor and research centre staff.
This is a Phase 2 clinical research study in which you will receive subcutaneous injections of the investigational study medicinal product or a placebo at specific time points. After an initial period of screening of up to 4 weeks, you will receive either the investigational study medicinal product or placebo and usual care for up to 48 weeks. There will be approximately 8 weeks of follow-up after the last dose of the investigational study medicinal product or placebo. Qualified participants will receive the investigational study medicinal product or placebo, lab tests and study-related medical care at no cost. If you choose to take part in the study, you may receive compensation for your time and travel costs for study visits.
Who can take part in the AIRCULES study?
To pre-qualify for this study, you must*:
Have had a medical diagnosis of moderate-to-severe Asthma for at least 12 months
Be currently treated with an inhaled corticosteroid and 1-2 additional controller medications
Have had an asthma attack or flare-up within the 12 months that required the use of steroids (oral, intravenous, or intramuscular) with or without emergency care or inpatient hospitalisation
*Please note that other criteria will apply
What would taking part in the study involve?
If you choose to take part in the study, there are a few different stages of the study.
The total study duration will last approximately 56 weeks. The study includes the following:
Screening Period (up to 4 weeks)
This is the time when the study doctor and staff determine whether you are eligible for the study, and you decide if you want to participate. During this period, you will need to undergo some tests and procedures. This will include a medication review for current Asthma treatments and breathing tests.
Study Treatment Period (48 weeks)
If you are eligible for the study, you will enter the Study Treatment Period, which lasts for 48 weeks and requires 14 visits to the study site. Participants have a seven out of nine chance (78% chance) of getting the investigational study medicinal product instead of the placebo.
During the study treatment period you will visit the study site repeatedly to receive an injection under the skin to abdomen, thigh, or upper arm of the investigational study medicinal product or a placebo. During your visits to the study site, you will also have other tests performed, such as blood and urine tests as well as breathing studies, and the study doctor and study team will monitor you closely.
On a daily basis throughout the study, you will use an eDiary to record daily how your symptoms are and perform brief at-home breathing tests.
Follow-Up Period (4 weeks)
There will be a follow-up period of 4 weeks after the Study Treatment Period is complete. During the follow-up period, you will undergo some procedures, such as blood, urine tests and vital sign checks.
How do I take part in the study?
Complete
the online questions to see if the study is a good match for you
Answer
our call to answer more questions and learn about the study
Confirm
your interest and research centre location
Speak
with the research centre about the next steps to take part
Frequently Asked Questions
Where can I find more information about this study?
You can learn more about this study by visiting https://clinicaltrials.gov/study/NCT06102005?cond=NCT06102005&rank=1
What is a clinical research study?
Clinical studies explore whether an investigational study medicinal product, treatment, or device is safe and effective for humans.
Clinical studies are scientific studies in which investigational study medicinal products and treatments are tested to find out if they are safe and effective for people to take and use. They are one of the most important steps in bringing new potential treatments to patients.
Why is clinical research important?
Clinical research adds to medical knowledge and helps bring new potential treatments to people with medical conditions. To bring new treatments to the public, they need 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 the clinical study, which can be due to a shortage of participants.
All approved prescription medicinal products have gone through clinical studies to make sure that they are effective and to understand what side effects may be involved.
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. The AIRCULES study is funded by AVENTIS PHARMA LIMITED, a pharmaceutical company.
Every clinical study centre is led by a principal investigator, who is a medical doctor or another health care professional. Clinical studies also have a research team, which may include doctors, nurses, and other health care professionals.
What are the phases of clinical research studies?
Clinical studies are conducted in different phases.
Phase 1: After researchers have investigated the potential investigational medicinal product in laboratory tests or in animals to see if it has an effect and ensure that it is safe to test in humans, the Phase 1 study is carried out to test the potential investigational medicinal product in a small group of people for the first time. This is done to evaluate its safety, determine a safe dosage range, and identify potential side effects. The potential investigational study medicinal product is referred to as a study medicinal product since it is under investigation and not yet approved for use.
Phase 2: The investigational study medicinal product is given to a larger group of people (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 people to confirm its efficacy, monitor side effects, compare it to commonly used treatments or placebo, and collect information that will allow the investigational study medicinal product to be used safely.
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.