Hoping to reduce asthma attacks?
Find out more about a new clinical study for adults and teenagers
People who take part may receive*:
- Study-related care from local doctors at no cost
- Study medication and tests at no cost
- Study-related medical care from specialist doctors
- Reimbursement for reasonable study-related travel expenses
A short questionnaire helps identify if you/your child are a match.
Final eligibility will be checked at a visit to a nearby study center.
About the MODIFY StudyWhat is the MODIFY Study?
Asthma attacks, a sudden worsening of asthma symptoms where airways narrow, can present as coughing, wheezing, chest tightness, and shortness of breath. They are associated with progressive loss of lung function and can result in hospitalization or even death. Asthma attacks may be treated with oral steroid medications, which have both short- and long-term side effects, including increased risk of infection, metabolic syndrome, weakened bones, and changes to vision.
Medications that can lessen the risk of asthma attacks and the associated need for steroid treatments would, therefore, help people with asthma live healthier lives.
The MODIFY Study wants to see if receiving an investigational medication as an injection under the skin once every 6 months alongside usual asthma medication can help reduce asthma attacks. We will also be looking at the safety of the investigational medication.
The investigational medication will be compared with placebo (an injection with no active medicine). The placebo and the investigational medication together will be referred to as the “study medication”.
About 450 teenagers and adults with asthma from across the world will take part in the study.
If you join, the amount of time you will be in the MODIFY Study will depend on when you enrolled and how fast the study recruits. All participants will be in the study for at least 2 years. At least 200 participants will continue for 3 years, with a final follow-up visit about 2 months after the last scheduled study visit.
What to expect
To find out whether you/your child may be eligible for the study, you will first complete a short online questionnaire. If you/your child are a potential match, you will be invited for a full eligibility check at a study center to see if the study is right for you/your child.
If you/your child are eligible to take part, you/they will need to visit the study center up to 12 times. There will also be times when you need to speak by telephone to the study team at the study center location.
Several tests and assessments will be performed to monitor your/your child’s health. These will include:
The MODIFY Study is split into 3 periods: screening, study treatment, and follow-up.
1
Screening period
(up to 1 month)
You/your child will visit the study center to see if the study is suitable for you/them and whether you want to take part.
2
Study treatment period
(up to 3 years)
- You/your child will:
- visit the study center up to 10 times for study assessments
- receive the study medication as an injection under the skin once every 6 months for either 2 years or up to 3 years
- have an additional “exit visit” to check your health about 6 months after your final study medication dose
- have up to 4 phone calls with the study team.
3
Follow-up period
About 2 months after your exit visit, you/your child will visit the study center once more for study assessments.
What is a clinical research study?
A clinical research study, also called a clinical trial or research study, is a carefully designed scientific evaluation of an investigational medication. Clinical research studies are conducted by doctors and researchers. A clinical research study helps to answer important questions about an investigational medication, such as:
- How safe is the investigational medication?
- Does it work?
What is an investigational medication?
A potential new (investigational) medication, also sometimes called an investigational drug or a study medication, has been tested in a laboratory. Based on those results, it has been approved by health regulatory authorities for testing in people. An investigational medication also may be a medication that is approved for the treatment of one disease or condition but is still under investigation in other diseases or conditions. An investigational medication can only be used in clinical research studies.
All investigational medications must be tested in clinical research studies before they can be approved by health regulatory authorities to be prescribed to patients. We need people to take part in clinical research studies so that new medications can be developed.
After reading all the information on this website, I still have questions about trying an investigational medication that may not work. Can you give me more information?
There are always risks and benefits of participating in a clinical research study. There is always a chance that the investigational medication could cause side effects or will not work. However, you should know that there are strict rules in place to monitor the safety of people taking part in a study. Before joining any clinical research study, it is important to consider the risks and understand them.
The study team will explain all the risks and benefits at the first study visit. Throughout the study, a team of doctors and nurses will monitor the health of the people taking part. They will be there to answer any questions you may have.
What happens next if I pre-qualify?
If you or your child pre-qualify, a member of the research team at a nearby study location will contact you. They will explain the study in more detail, answer your questions, and guide you through the next steps. This will most likely include an in-person or virtual visit to check additional criteria in order to confirm your eligibility. The research teams can be very busy so it may take a few days to receive the call or message. If it has been 3 or more days since you pre-qualified, you can call the study center at the phone number in your confirmation email.
What does it mean to ‘pre-qualify’ for a clinical study?
Pre-qualifying means you match basic study requirements, but it does not guarantee that you will be able to take part. Pre-qualification is only based on information you provide through the online questionnaire completion. Think of pre-qualifying as the first step to see if a study may be a good fit for you based on factors such as medical conditions, prescription medicine usage, procedure history, and more. If you pre-qualify, you will receive a message with details on the name of the research team that will aim to confirm your full eligibility through additional questions and/or medical assessments. There is a chance that you may not ultimately qualify based on the additional criteria the study team will check.
Why might I not pre-qualify?
Each study has specific requirements to help keep participants safe and ensure meaningful results. You might not pre-qualify if your medical history, current medication usage, or other factors including diagnosis timing, pregnancy status, and symptom severity don’t fit with study requirements.
Where are the study center locations?
When you complete the questionnaire, your ZIP or postal code will be the key factor in trying to match you to a nearby study location. Every study has different locations. Sometimes one study location will close for enrollment while a new one will open. If there is no study location nearby when you complete the questionnaire, you can choose to be contacted if one opens later that is close to where you live or work. If the location offered to you is too far, you can decline.
Is there a cost to take part?
The study-required investigational medication or placebo will be provided at no cost. The person taking part in the study will also receive study-related care from a team of experienced doctors and nurses throughout the study at no cost.
Will participant confidentiality be protected?
All personal information will remain confidential, and data will only be collected and used as necessary to support an individual’s match to and participation in a study. Participants’ names will not be included in any data reported. For more information, including how and why we process personal data, please read our Privacy Policy.
Are clinical research studies safe?
Clinical research studies must undergo rigorous reviews and follow strict rules. These rules help to ensure that the rights, safety, and well-being of participants are at the forefront of any study.
Participating in a clinical research study comes with risks as well as benefits. Before joining a study, potential participants must make sure they understand the benefits, such as getting access to study-related medical care and maybe helping others in the future. They must also understand the risks, such as unknown side effects. Potential study participants can take as much time as they need to decide whether to take part and get as much information as they can. Before joining a study, the potential study participant will be asked to sign an informed consent form, which will include a full explanation of the study, including its potential risks. If the potential study participant is not capable of giving informed consent, a legally authorized representative may provide informed consent on their behalf. In this situation, the potential study participant would provide informed assent.
What else should someone thinking about taking part in a clinical study consider?
It is a personal decision to take part. Participation in the study is voluntary. Please also consider:
- If a decision is made to participate, you or your child can withdraw at any time during the study.
- The study team will explain the possible benefits and risks of the study during the informed consent process.
- A person does not have to join any study if they don’t want to.
- A team of doctors and nurses will carefully monitor the health of people taking part during the study.
- The investigational medication or placebo will be provided at no cost.
- Taking part in the study may help other people with asthma in the future.
People taking part in the study will need to follow all the instructions from the study doctor and nurses
See If You Pre-Qualify
