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Epigenetic Health Benefits of Budesonide

Study acronym: Project Ace
StatusActive, Not Recruiting
PhasePhase 4
Started
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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.

Record History

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  1. Notable Primary completion date: Dec 31, 2024 to Dec 31, 2025
    • Study completion date: Dec 31, 2025 to Dec 31, 2027
    v8
  2. Notable Primary completion date: Dec 31, 2023 to Dec 31, 2024
    • Study completion date: Dec 31, 2024 to Dec 31, 2025
    v7
  3. Notable Primary completion date: Dec 31, 2022 to Dec 31, 2023
    • Secondary endpoints: 5 to 6
    v6
  4. Minor Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Dec 31, 2022 to Dec 31, 2024
    • Site details revised
    v5
  5. Notable Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Primary completion date: May 1, 2021 to Dec 31, 2022
    • Study sites: 0 to 1
    • Study completion date: May 1, 2023 to Dec 31, 2022
    • Start date changed from estimate of Nov 1, 2020 to Jan 7, 2021
Show 2 earlier versionsHide 2 earlier versions
  1. Notable Start date: Sep 1, 2020 to Nov 1, 2020v3
  2. Notable Start date: May 1, 2020 to Sep 1, 2020v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04342039
Lead Sponsor University of British Columbia
Collaborators: Genome British Columbia, Johnson & Johnson Consumer Inc. (J&JCI)
Conditions
(from sponsor)
Epigenetic Effects of Intranasal Steroids, Environmental Exposure
Related terms Rhinitis, Allergic
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov