Is Chronic Rhinosinusitis, also known as Chronic Sinusitis (CRS), having a significant impact on your daily life?
Learn about an exciting clinical study for an investigational study medicinal product
Answer a few questions to see if you qualify for a clinical study for people living with Chronic Rhinosinusitis.
Short Summary
Medical Condition:
Chronic Rhinosinusitis with or without polyps
Participation duration:
Between 24 to 52 weeks, depending on the study
Phase:
2 or 3
What is Chronic Rhinosinusitis?
Chronic Rhinosinusitis (CRS) is a condition where the nose and sinuses are inflamed and swollen. If you have CRS, you might experience symptoms like a blocked or stuffy nose, a runny nose, pain or pressure in your face, or a reduced sense of smell. These symptoms last for 12 weeks or more. Some people with CRS also develop small growths in their nose called nasal polyps. Living with CRS can be demanding, as it can affect your energy levels, sleep, thinking, mood, and overall quality of life.
What is the Chronic Rhinosinusitis clinical study?
The CRS clinical study is researching an investigational study medicinal product for participants with chronic rhinosinusitis. The goal of this study is to determine if the investigational study medicinal product is safe and effective for people living with the burden of chronic rhinosinusitis.
The study aims to evaluate how effective and safe the investigational study medicinal product is. The investigational study medicinal product works by blocking signals from the immune system which are responsible for inflammation. This clinical study is investigating the effect the investigational study medicinal product has on chronic rhinosinusitis symptoms.
The investigational study medicinal product is not approved by the health authority in Australia, Therapeutic Goods Administration (TGA), and is still under investigation for the treatment of chronic rhinosinusitis, so its effectiveness and safety have not been established.
Who can participate?
The clinical study is seeking participants with Chronic Rhinosinusitis, with or without nasal polyposis.
Who are 18 years old or older
Have had a history of CRS symptoms for at least 1 year
Prior sinus/nasal surgery or you have tried oral steroid for your CRS which has not worked
Please note there are more eligibility criteria that must be met to be considered for participation.
What happens if I participate?
Screening Period (4 weeks)
-
This is when the study doctor and staff will determine whether this clinical study will be suitable for you, and you can decide whether you want to participate. Once specific tests and assessments are completed, and you meet all the required criteria for participation, the study treatment period will commence.
Study Treatment Period (24 to 52 weeks)
-
During this period, you will be randomly assigned to receive either the investigational study medicinal product or a placebo. A placebo looks like the investigational study medicinal product but does not contain any active medications. Both the investigational study medicinal product and the placebo will be administered as an injection under the skin. The likelihood of you receiving placebo is approximately 1/3; however, neither you nor the study site team will know whether you are receiving the investigational study medicinal product or the placebo during the study treatment period.
-
During your visits, you will receive your injection and undergo additional tests, including blood sampling, urine collections, and physical examinations. Throughout the clinical study the research team will closely monitor your progress and health.
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?
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 the clinical study. The study site of your choice will be provided with your contact details in order to schedule an appointment to share more details about the study and learn about your medical history.
Where can I find more information about the CRS clinical study?
If you are interested to learn more about the clinical study, we encourage you to complete a few questions to help assess if there is a study that 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 study?
Any medical care, tests or procedures that are for the purpose of the study will be provided and will be explained by the study site. There is no insurance required to participate. As you will need to visit the study site throughout the duration of the study, travel reimbursement will be available.
Why are clinical studies important?
Clinical studies add to medical knowledge and help to 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 participants. 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.
All approved prescription medicinal product have gone through clinical studies to assess their safety and efficacy 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 CRS study is funded by SANOFI-AVENTIS AUSTRALIA PTY LTD, a pharmaceutical company.
Every study site is led by a principal investigator, who is 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 trials to ensure that the rights and welfare of clinical study participants are protected.
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 people 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 trials.
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 assessment of the investigational study medicinal product ’s safety. The CRS trial is a phase 2 and 3 study.
Intended for Australian Audiences Only © 2024 SANOFI-AVENTIS AUSTRALIA PTY LTD. All Rights Reserved.