NCT04342039: Project Ace

Epigenetic Health Benefits of Budesonide

Active, enrolled Phase 4 Last updated 27 March 2025

What this trial tests

Phase 4 trial testing Budesonide Nasal in Epigenetic Effects of Intranasal Steroids in 20 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

7 January 2021

Primary endpoint
31 December 2025

31 December 2027

Quick facts

Lead sponsor	University of British Columbia
Phase	Phase 4
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Primary purpose	basic science
Enrollment	20
Start date	7 January 2021
Primary completion	31 December 2025
Estimated completion	31 December 2027
Sites	1 location across Canada

Drugs / interventions tested

• Budesonide Nasal — full drug profile →
• Placebo

Conditions studied

• Epigenetic Effects of Intranasal Steroids — all drugs for Epigenetic Effects of Intranasal Steroids →
• Environmental Exposure — all drugs for Environmental Exposure →

Sponsor

University of British Columbia

Who can join

Adults 18 to 65, any sex, with Epigenetic Effects of Intranasal Steroids or Environmental Exposure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Nasal budesonide mitigates air pollution effects in adults with allergic rhinitis: A randomized trial.
   Halbe E, Rider CF, Yuen ACY, Johal P, et al · · 2026 · PMID 41759721 · DOI 10.1016/j.anai.2026.02.004
2. The Modulation of Cell Plasticity by Budesonide: Beyond the Metabolic and Anti-Inflammatory Actions of Glucocorticoids.
   Patriarca EJ, D'Aniello C, De Cesare D, Cobellis G, et al · · 2025 · PMID 40284499 · DOI 10.3390/pharmaceutics17040504