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AIRLYMPUS:
Are you living with asthma?
Learn about a new investigational study medication being studied for asthma treatment. See if you may qualify & be a part of advancing care for asthma patients globally.
Short Summary
Medical Condition:
Asthma
Participation duration:
Approximately 52 weeks
Phase:
2
What is the AIRLYMPUS clinical study?
The AIRLYMPUS study aims to evaluate if an investigational study medication can:
Help reduce asthma attacks
Reduce the need to use rescue medication to treat asthma symptoms, and
Improve your ability to breathe easily.
The AIRLYMPUS study is a randomised, double-blind, placebo-controlled study.
Randomisation means that a computer will randomly assign participants to receive either the investigational study medication or the placebo.
Double-blind means neither you nor your study doctor will know whether you are receiving the investigational study medication or placebo.
The placebo looks like the investigational study medication but contains no active medication.
The investigational study medication is not approved by health authorities such as the South African Health Products Regulatory Authority (SAHPRA) and is still under investigation for the treatment of asthma, so its effectiveness and safety have not been established.
Who can participate?
To participate you must:
Be aged between 18 and 80 years
Have been diagnosed with asthma for at least 1 year
Have not smoked or vaped in the last 6 months
Please note there are more eligibility criteria that must be met to be considered for participation.
How do I participate?
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 research centre location
Speak with the research centre about the next steps to participate
Find out if the AIRLYMPUS asthma study might be a match for you.
Please answer a few questions to see if you may qualify for a study.
With your consent, we (Trialbee) will collect and use the information you submit here to indicate your interest in the 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 study participation.
What happens if I participate?
Screening Period (up to 4 weeks)
The study doctor and team at the research centre will assess your eligibility for the study, and the decision to participate will be yours to make. Once specific tests and assessments are completed, you meet all the required criteria for participation and you consent, Part A of the study will commence.
Part A – Run-In Period (up to 4 weeks)
During Part A, also known as the run-in period, you will receive a new inhaler to use to treat your asthma given to you by the study doctor. At the end of Part A, the study team will perform a respiratory test to assess your eligibility for the AIRLYMPUS study.
If the respiratory test results show that you may not benefit from the investigational study medication, the study doctor and research team will not move you to Part B. Instead, you will enter the follow-up period at the end of Part A.
If the respiratory test results show that you may benefit from the investigational study medication, you will move to Part B of the study.
Part B – Study Treatment Period (approximately 52 weeks)
During Part B, also known as the study treatment period, you will receive either the investigational study medication) or a placebo. A placebo will look like the investigational study medication but does not contain any active medicine. Both the investigational study medication and placebo, depending on what you are assigned to, are administered as a subcutaneous (under the skin) injection. Neither you nor the research centre team will know whether you are taking the investigational study medication or placebo during the study treatment period. The study treatment period will last approximately 52 weeks and will require visits to the research centre. During your visits to the research centre, you will receive your injection and undergo additional tests, including blood draws and respiratory tests conducted by the study team. The research centre team will closely monitor your progress.
Follow-Up Period (approximately 4 weeks)
If you complete Part A only, you will enter the follow-up period and visit the research centre for a follow-up appointment with the study doctor.
If you complete Part B, there is an option to participate in the long-term safety study with the investigational study medication, if approved by the relevant health authorities and institutional review boards. If you decide to enrol in this long-term safety study, you will not take part in the AIRLYMPUS follow-up period but will instead enter a different follow-up period as part of the long-term safety study. If you choose not to participate in the long-term safety study, you will complete a 4-week follow-up period.
Screening Period
Part A – Run-In Period
Participants not eligible for Part B
Participants eligible for Part B
Part B – Study
Treatment Period
Follow-up Period
Participantes no elegibles para la Parte B.
Screening Period
Screening Period (up to 4 weeks)
The study doctor and team at the research centre will assess your eligibility for the study, and the decision to participate will be yours to make. Once specific tests and assessments are completed, you meet all the required criteria for participation and you consent, Part A of the study will commence.
Part A – Run-In Period
Part A – Run-In Period (up to 4 weeks)
During Part A, also known as the run-in period, you will receive a new inhaler to use to treat your asthma given to you by the study doctor. At the end of Part A, the study team will perform a respiratory test to assess your eligibility for the AIRLYMPUS study.
If the respiratory test results show that you may not benefit from the investigational study medication, the study doctor and research team will not move you to Part B. Instead, you will enter the follow-up period at the end of Part A.
If the respiratory test results show that you may benefit from the investigational study medication, you will move to Part B of the study.
Part B – Study Treatment Period
Part B – Study Treatment Period (approximately 52 weeks)
During Part B, also known as the study treatment period, you will receive either the investigational study medication) or a placebo. A placebo will look like the investigational study medication but does not contain any active medicine. Both the investigational study medication and placebo, depending on what you are assigned to, are administered as a subcutaneous (under the skin) injection. Neither you nor the research centre team will know whether you are taking the investigational study medication or placebo during the study treatment period. The study treatment period will last approximately 52 weeks and will require visits to the research centre. During your visits to the research centre, you will receive your injection and undergo additional tests, including blood draws and respiratory tests conducted by the study team. The research centre team will closely monitor your progress.
Follow-Up Period
Follow-Up Period (approximately 4 weeks)
If you complete Part A only, you will enter the follow-up period and visit the research centre for a follow-up appointment with the study doctor.
If you complete Part B, there is an option to participate in the long-term safety study with the investigational study medication, if approved by the relevant health authorities and institutional review boards. If you decide to enrol in this long-term safety study, you will not take part in the AIRLYMPUS follow-up period but will instead enter a different follow-up period as part of the long-term safety study. If you choose not to participate in the long-term safety study, you will complete a 4-week follow-up period.
Frequently Asked Questions
Where can I find more information about the AIRLYMPUS clinical study?
If you are interested in learning more about the AIRLYMPUS study, we encourage you to complete a few questions to help assess if the study could be a match.
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 research centres conducting the clinical study. The research centre of your choice will be provided with your contact details to schedule an appointment to share more details about the study and learn about your medical history.
What type of study-related medical care is provided during the study?
Any medical care, tests or procedures that are for the purpose of the study will be provided and will be explained by the research centre. There is no insurance required to participate. As you will need to visit the research centre throughout the duration of the study, there may be travel reimbursement available.
Who runs clinical studies?
Clinical studies can be sponsored, or funded, by pharmaceutical or biotechnology companies, academic medical centres, voluntary groups or healthcare providers. These studies are funded by Sanofi-Aventis Recherche & Développement Inc, a pharmaceutical company.
Every research centre is led by a principal investigator, who is usually a medical doctor. Clinical studies also have a research team that may include doctors, nurses and other healthcare professionals. An independent committee of people from outside the study sponsor, called an ethics committee or institutional review board, reviews and monitors clinical trials to ensure the rights and welfare of clinical study participants are protected.
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