Active not recruitingPHASE4INTERVENTIONAL

Epigenetic Health Benefits of Budesonide

Allergies affect many people, and we know they're linked to our genes and environment. Things like dust mites, pollen, and pollution can change how our genes work, a process called 'epigenetic modification'. This study investigates if budesonide, a nasal spray often used for allergies, can undo these changes. While we know budesonide helps with inflammation, we're now exploring if it also works by correcting these gene modifications. This research could help us understand how allergies start and how to treat them more effectively, potentially leading to new ways to manage allergies or pollution exposure.

At a glance

Status

Active not recruiting

Phase

PHASE4

Sponsor

University of British Columbia

Enrolment target

Start

07 Jan 2021

Estimated completion

31 Dec 2027

Epigenetic Effects of Intranasal Steroids Environmental Exposure

What is this study about?

Allergies are becoming more common, affecting nearly half the world's population. We now understand that allergies don't just happen; they're a result of a complex interplay between the genes we inherit and the environment we live in. Things like pollen, dust mites, and even air pollution can actually change how our genes act, without changing the genes themselves. Think of it like turning a light switch on or off without rewiring the house; these changes are called 'epigenetic modifications'. These changes can sometimes make people more prone to allergies.

Good news is, these epigenetic changes seem to be reversible. This study is exploring if budesonide, a common nasal spray (you might know it as Rhinocort®) used to treat allergy symptoms, can help reverse these changes. We already know budesonide is good at reducing inflammation, but recent research suggests it might also work by correcting these epigenetic modifications caused by allergens and pollution. This trial will help us understand if this really happens in people with real-world allergen exposure.

The main goal of this study is to use advanced tests to see if budesonide can change how genes behave in people with allergies. By understanding this, we can fill important gaps in our knowledge about how our environment affects our health and how treatments work. This could lead to a better understanding of how budesonide treats allergy symptoms, and potentially open doors to new and improved ways to treat allergies or even the effects of pollution. If successful, this approach could also be used to study other treatments and diseases.

Key takeaways

Exploring if a common nasal spray can reset how genes react to allergens and pollution.
Aims to improve our understanding of allergy causes and treatments.
Involves using both the study drug and a non-active spray at different times.
Requires regular hospital visits for nasal sampling and symptom checks.
Your participation helps advance allergy research for future generations.
Results may not be personally noticeable but are crucial for science.

Who may be eligible?

This study is looking for healthy men and women between the ages of 18 and 65. For women, you must either have gone through menopause, had a procedure that prevents pregnancy, or be using reliable birth control methods (like the pill or an implant). You shouldn't be experiencing allergy symptoms at the exact time you join the study, but you must have a clear diagnosis of allergic rhinitis (like hay fever from dust mites, grass, or tree pollen) that you've had for at least the past two years. Importantly, your allergy symptoms must have been severe enough in the last two years during pollen season that you needed medication to manage them.

You should not join this study if you are allergic to budesonide. We also can't include you if you have other serious health conditions like heart, lung, kidney, or liver problems, or if you have certain hormonal issues, as these might affect the study results. You also can't be pregnant or breastfeeding, or have plans for a hospital stay or blood donation during the study period.

Additionally, if you have certain nose problems like a crooked septum, polyps, or ongoing infections, or if you have a history of asthma, this study might not be suitable for you.

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 between 18 and 65 years old?
Do you have a diagnosis of moderate-to-severe allergic rhinitis that has needed treatment for the past two years?
Are you currently not experiencing significant allergy symptoms?
Are you able to attend all planned hospital visits?
For women, are you not pregnant or breastfeeding, and using reliable contraception if applicable?
Do you have any serious underlying health conditions like heart, lung, or kidney disease?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you'll be involved in two treatment periods. In one period, you'll use the budesonide nasal spray, and in the other, you'll use a 'dummy' spray (placebo) that contains no medicine. You won't know which one you're using at any given time. This 'crossover' design means you'll act as your own comparison. You'll switch between the two after a break period where you don't use any spray.

Throughout the study, you'll have several in-person visits to the hospital. During these visits, the research team will take samples from your nose, ask you to fill out questionnaires about any symptoms you experience, and measure how air flows through your nose. They will also try to gently expose you to small amounts of allergens or pollution during some visits to see how your nose reacts to the treatments. On days when you're not at the hospital, you'll continue to use the test nasal spray daily as instructed. The researchers expect that any changes from the treatment or exposures might be very subtle and not something you'd notice yourself. These changes will likely only be seen by looking closely at the samples taken from your nose at a genetic level. The total duration of the study, including both treatment cycles and the break, will be explained in full detail if you are interested.

Potential risks and benefits

Participating in this study might not bring you a direct, noticeable health benefit, as the changes we're looking for are very subtle and require detailed lab tests. However, your involvement is incredibly valuable as it will help us understand allergies and existing treatments much better, potentially leading to new and improved options for many people in the future. As with any medication, there's always a small chance of side effects, even with a commonly used nasal spray like budesonide. These will be fully explained to you before you agree to take part. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

University of British Columbia
Verified postcode
Vancouver, Canada

Common questions

What are 'epigenetic modifications'?

These are like switches that turn genes on or off, changing how your body works without actually changing your DNA. Allergens and pollution can flip these switches.

What is budesonide?

Budesonide is a common steroid nasal spray (like Rhinocort®) used to reduce inflammation and treat allergy symptoms.

Will this study cure my allergies?

This study aims to understand how budesonide works at a deeper level. While it won't be a direct cure, it could help us develop better treatments in the future.

Will I know if I'm getting the real medicine or a dummy spray?

No, this is a 'blinded' study, meaning you won't know if you're using the active medicine or the placebo. This helps ensure unbiased results.

What does a 'crossover design' mean?

It means you'll use both the active medicine and the dummy spray at different times during the study, with a break in between. This helps us compare the effects directly in the same person.