Clinical Trial

Epigenetic Health Benefits of Budesonide

Study acronym: Project Ace
Active, Not Recruiting Phase 4
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Record status
This record was last updated March 27, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
Around 40% of the world's population is now impacted by allergic disease and this figure continues to rise. It is now understood that allergic disease arises from complex interactions between genetic and environmental factors. Exposure to allergens such as dust mites and pollen, as well as air pollutants such as diesel exhaust particulates, can alter the ability of critical genes to be expressed appropriately, a process known as epigenetic modification. The epigenetic modifications induced by allergens and pollutants appears to be reversible, thus providing a mechanism by which allergic disease can be treated. Budesonide (Rhinocort®) is a corticosteroid nasal spray commonly used to treat allergy symptoms. While the anti- inflammatory and other pharmacological aspects of budesonide are well understood, recent studies have suggested that budesonide may also work by reversing the epigenetic modifications caused by allergen exposure, although this has not been examined in the context of real-world exposures in humans. This study aims to harness the power of epigenetic analysis to determine whether the epigenetic landscape in patients suffering from allergic disease can be modified by the administration of budesonide. It will fill critical gaps in understanding of epigenetic effects and provide information to examine the connection between environmental impacts and treatment effects. The research will expand the mechanistic understanding of the therapeutic effects of budesonide for relief of nasal rhinitis symptoms and may reveal new mechanisms that could improve treatment of allergies or pollution exposure, or serve as a tool for evaluating future therapies. If this venture is successful, it will serve as a model for studying and optimizing the epigenetic effects of other treatments and other diseases.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2020-04-09; most recent amendment 2025-03-24.
Status change: Recruiting → Active, Not Recruiting 2022-11-10
Status change: Not Yet Recruiting → Recruiting 2021-10-29
Trial Details
NCT Number NCT04342039
Lead Sponsor University of British Columbia
Collaborators: Genome British Columbia, Johnson & Johnson Consumer Inc. (J&JCI)
Conditions Epigenetic Effects of Intranasal Steroids, Environmental Exposure
Enrollment 20 participants
Start Date 2021-01-07
Primary Completion 2025-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-03-27