RecruitingPHASE4INTERVENTIONAL

Olfactory Outcomes of Dupilumab Treatment for Nasal Polyposis

This study is investigating how a medicine called Dupilumab (also known as Dupixent) affects the sense of smell in adults who have long-lasting sinus problems with nasal polyps. Nasal polyps can often cause a loss of smell. This research will follow 27 patients who are already receiving Dupilumab treatment. Over six months, researchers will check their sense of smell using a special test. They'll also look at how much the nasal polyps shrink and how the patients' quality of life related to their sense of smell changes. The goal is to understand if Dupilumab can improve or restore a patient's ability to smell.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Enrolment target

Start

19 Jul 2021

Estimated completion

01 Dec 2025

Chronic Rhinosinusitis With Nasal Polyps Olfactory Disorder

What is this study about?

This research study is focused on understanding how a treatment called Dupilumab, also known as Dupixent, can help people who have chronic, long-term sinus problems with nasal polyps, especially if their sense of smell is affected. Nasal polyps are soft, painless growths inside your nose or sinuses, and they can often block your airways and significantly reduce or completely take away your ability to smell and taste. Dupilumab is a medication already used to treat this condition, and this study aims to specifically measure its impact on regaining a sense of smell.

The main purpose is to carefully check if Dupilumab improves a patient's ability to smell. To do this, a special "Sniffin' Sticks" test will be used. This test measures different aspects of smell, like how low a smell needs to be before you can detect it (threshold), your ability to tell different smells apart (discrimination), and how well you can name specific smells (identification). By doing these tests at the beginning of treatment and then again after three and six months, the researchers hope to see if there's a noticeable improvement in the sense of smell over time.

Beyond just smell, the study will also look at how Dupilumab affects the nasal polyps themselves (whether they shrink), and how it generally impacts the patient's quality of life, particularly concerning any negative feelings or difficulties caused by their smell disorder. This will help doctors and patients understand the full range of benefits that Dupilumab might offer for people living with chronic sinus issues and a diminished sense of smell.

Key takeaways

This study is for adults with chronic rhinosinusitis and nasal polyps.
It investigates if Dupilumab treatment improves the sense of smell.
Participation involves three clinic visits over six months.
A special 'Sniffin' Sticks' test measures changes in smell.
It also checks polyp size and quality of life related to smell.
You must already be on Dupilumab and have smell loss from polyps.

Who may be eligible?

To be considered for this study, you need to be an adult (18 years or older) and have been diagnosed with chronic rhinosinusitis, which is a long-term inflammation of your sinuses, along with nasal polyps. A key requirement is that you must also be experiencing a loss of your sense of smell due to these conditions. Crucially, your doctor must have already decided that Dupilumab is the right treatment for you based on your medical needs.

However, there are reasons why you might not be able to join the study. For example, if your loss of smell is thought to be caused by something else not related to your chronic sinusitis and nasal polyps, such as certain nasal cancers, a head injury, or if the cause of your smell loss is unknown. Likewise, if you've used certain recreational drugs like cocaine or had smell loss due to a COVID-19 infection, you wouldn't be eligible.

Finally, if you are pregnant, for safety reasons you would not be able to take part in this study. The study wants to be sure it's measuring the effects of Dupilumab on smell loss specifically due to nasal polyps, so it's important to rule out other possible causes.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have long-term sinus problems with nasal polyps?
Have you lost your sense of smell because of your nasal polyps?
Has your doctor already prescribed Dupilumab (Dupixent) for you?
Is your smell loss NOT due to other causes like injury, certain illnesses, or COVID-19?
Are you not currently pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will continue with your regular Dupilumab treatment as prescribed by your doctor. Over a period of six months, you will attend three visits at the Otolaryngology Clinic (which is a clinic for ear, nose, and throat issues). These visits will happen at the very beginning of the study (called 'baseline'), then after three months, and again after six months. During each visit, you will have your sense of smell tested using the 'Sniffin' Sticks' test. The doctors will also check the size of your nasal polyps and ask you questions about how your sense of smell affects your daily life and overall well-being. The total duration of your active participation in the study will be six months.

Potential risks and benefits

Taking part in this study means you would be receiving treatment that your doctor has already decided is right for you. The potential benefit is that the study could provide valuable information on how Dupilumab specifically helps improve the sense of smell for people like you, which could contribute to better understanding and treatment for others in the future. As you would already be taking Dupilumab, the risks are generally those associated with the medication itself, which your doctor would have discussed with you. As with all studies, you are free to withdraw at any time without giving a reason, and this will not affect your usual medical care.

Locations (1)

St. Joseph's Health Care
Verified postcode
London, Canada· Recruiting

Common questions

What is Dupilumab?

Dupilumab is a medicine, also known as Dupixent, used to treat certain conditions including chronic sinus problems with nasal polyps.

What are nasal polyps?

Nasal polyps are soft, non-cancerous growths inside your nose or sinuses that can cause blockages and affect your sense of smell.

What is the 'Sniffin' Sticks' test?

It's a special test used to accurately measure different aspects of your sense of smell, like detecting, telling apart, and identifying odours.

Will I get a new medicine if I join this study?

No, this study is for people already prescribed and taking Dupilumab for their nasal polyps.

How long will the study last for me?

Your participation in the study will involve a total of three visits over six months.

How to find out more

Cristian Dihel, MD

cristian.dihel@sjhc.london.on.ca +15196466100 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.