Completed

Project ACE

A Randomized, Double-Blind, Placebo-Controlled Study of Epigenetic Effects of Intranasal Budesonide Aqueous Spray During Controlled Nasal Allergen and Pollution Challenges in a Controlled Exposure Lab

Study Details


Identifier
NCT04342039
Status
Complete
Age
19-65 years old
Location
Vancouver, BC
Subjects
Allergic Rhinitis
Phase
4
Time
15 visits (1-3 hours/visit)

Screening

  • Physical Exam by Respirologist

  • Allergen Skin Prick Test

  • Allergen Challenge

  • ECG Test

  • Lung and Nasal Function Testing

  • Blood, urine, and nasal sample collections

  • Medical History Questionnaires

  • Diesel Exhaust and Allergen Exposures

Around 40% of the world’s population is impacted by some form of allergic disease (ie: seasonal allergies), and this number continues to rise. An allergic response is known to be caused by both genetic and environmental factors. When our bodies come in contact with allergens such as dust mites, pollen, and air pollutants (diesel exhaust particulates), this can cause changes to our genes.

Genes are made of a molecule called deoxyribonucleic acid, or DNA for short. There is also another type of molecule called ribonucleic acid (RNA) that works closely with your genes. All of this is contained inside cells within your body. Changes to the genes or RNA may affect a person’s chance of developing certain diseases. Changes can be inherited (passed on in families from parents to children) or caused by external factors such as allergen or pollution exposures described above. Changes can be permanent or they can come and go. When genes are affected by the environment, we call it an epigenetic modification.

A gloved hand holds a dropper above an arm with a grid marked in ink, during an allergen skin prick test. In the background, several small bottles of allergens are visible.

This study is trying to identify the epigenetic modifications that happen when the human body is exposed to allergens and pollution, something that we encounter on a daily basis. To take that question further, we also want to know if Budesonide (Rhinocort®), a nasal spray corticosteroid medication that is often used to treat allergen responses, can reverse the epigenetic modifications caused by the exposures. Being able to understand what changes occur with or without the drug under the different exposure will help researchers optimize more effective treatments for future use.