The DUET Study - a clinical research study for adults who have chronic rhinosinusitis with nasal polyps (CRSwNP)
Fifth Sense is working to improve access to treatments and clinical trials for people with chronic rhinosinusitis with nasal polyps (CRSwNP). As part of this, we have been working with global healthcare company Sanofi who are now recruiting adults with chronic rhinosinusitis with nasal polyps to a new clinical study called the DUET Study.
You can find out more about the study and how to get involved if you are eligible below.
Study summary
The purpose of the DUET study is to determine how effective the study drug is in reducing the signs and symptoms of chronic rhinosinusitis as well as the size of associated nasal polyps.
Current medicines for people with chronic rhinosinusitis with nasal polyps aim to reduce swelling and symptoms. These treatments usually include steroid nasal sprays, and steroid pills, or other biologic/injectable drugs (although biological drugs that may provide long-term benefit for CRSwNP cannot be prescribed in the UK at present). Surgery is also an option. However, many people continue to have symptoms that interfere with their daily lives and better medicines are needed.
This new clinical study is seeking participants experiencing chronic rhinosinusitis with nasal polyps aged between 18 and 70 years old.
The goal of this study is to determine if the study drug is safe and effective for people living with the burden of chronic rhinosinusitis. The study drug works by blocking signals from the immune system which are responsible for inflammation.
The study drug is not approved by health authorities (Medicines and Healthcare products Regulatory Agency (MHRA) and is still under investigation for the treatment of chronic rhinosinusitis, so its effectiveness and safety have not been established.
Chronic rhinosinusitis with nasal polyps is a chronic inflammatory disease of the nose and sinuses with co-existence of nasal polyps and chronic symptoms of sinusitis which may severely impact a patient’s quality of life.
Nasal polyps are swellings or “lumps” on the nose that can block the nose and cause feelings of congestion/obstruction. Patients also commonly experience a reduced or lost sense of smell, runny nose, post-nasal drip and facial pain.
Who can take part in the DUET study?
You may be eligible if you:
- Are between 18- and 70-years-old
- Have nasal polyps that your doctor has identified, despite having used corticosteroid treatment for at least 2 months
- Are experiencing the following symptoms:
- Nasal congestion, blockage, and/or obstruction
- Partial loss of smell (hyposmia) or total loss of smell (anosmia), and/or a runny nose and/or post-nasal drip (anterior and/or posterior rhinorrhoea)
What does taking part in this study involve?
If you meet the eligibility criteria for the study and agree to take part, you will be randomly selected to receive either the study drug or a placebo (an inactive substance). There is a 1 in 2 chance that you will receive the study drug. The study drug or placebo will be injected under the skin of the abdomen, thigh, or upper arm.
You would need to attend the study site 11 times over a period of 40 weeks (around 9 months) to undergo tests, including:
- CT scan
- Nasal endoscopy
- Respiratory measurements
You will be provided with an eDiary (a small device that looks like a mobile phone). You will need to use it every day to record your symptoms and medication use.
Study rules
Participation in this study means that you agree to follow certain study rules. This will also help to ensure your safety.
- Provide truthful information about medical condition(s) and medication(s) that you have been taking.
- Follow your study doctor’s instructions regarding the study medication’s administration.
- Inform the study doctor before stopping or modifying your medication(s) or before starting any new medication(s).
- Attend the scheduled visits and allow the tests or procedures to be performed as planned.
- Inform the study doctor or study staff, as soon as possible, of any side effects or health problems even if you do not think they are caused by the study medication(s).
I’m interested in applying. How do I find out more?
If you are interested in participating and would like more information about the study, please click the link below to visit the DUET study webpage. If you have any questions about the study you can contact the research team via the contact form there.
Sanofi has provided a service fee to Fifth Sense in exchange for their support in patient recruitment for this study. This financial arrangement is intended to compensate Fifth Sense for their time and resources dedicated to assisting with the recruitment process. The service fee does not influence the independence of Fifth Sense or the integrity of the patient recruitment process.