Status:
ACTIVE_NOT_RECRUITING
Epigenetic Health Benefits of Budesonide
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
Genome British Columbia
Johnson & Johnson Consumer Inc. (J&JCI)
Conditions:
Epigenetic Effects of Intranasal Steroids
Environmental Exposure
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 ...
Detailed Description
To test this, the investigators have planned for two treatment trials where participants will act as both the control and tester (crossover design method). Participants will be provided a randomized t...
Eligibility Criteria
Inclusion
- Healthy men and women aged 18 - 65 years. (Female subjects must be postmenopausal, surgically sterile or using medically accepted contraceptive means, as judged by the investigator).
- Asymptomatic subjects (not experiencing rhinitis symptoms at the time of screening).
- A clinical diagnosis of allergic rhinitis (dust mite, grass mix or tree mix) for at least the previous two years.
- Subjects with a need of treatment for their nasal symptoms during the pollen season of such severity that it required pharmacological therapy each year for the last two consecutive years.
- Willingness to participate as indicated by a signed informed consent. Signed consent must be obtained from the subject prior to start of any study-related procedures.
- Availability and ability for all planned site visits
- A nasal allergen challenge resulting in at least five sneezes and/or a recorded score of \>2 in either nasal obstruction or runny nose
Exclusion
- Subjects with confirmed hypersensitivity to budesonide.
- Subjects with previous or current respiratory- cardiovascular-, renal-, liver-, endocrinological or other diseases or conditions which may influence the subject's participation in the study or the result hereof, as judged by the investigator.
- Subjects with a planned hospitalization or planned blood-donation during the study.
- Women who are pregnant or nursing.
- Diseases or conditions which might interfere with the evaluation of efficacy and safety:
- Subjects with structural abnormalities of the nose (e.g. septal deviation, nasal polyps) or other diseases (infectious rhinitis, sinusitis, rhinitis medicamentosa and atrophic or non- allergic rhinitis) which could cause significant nasal obstruction or other symptoms which could have any significant influence on the investigated disease as judged by the investigator.
- History of asthma.
- PAR (with an exception, see inclusion criterion 3).
- Subjects allergic to other allergens occurring during the study period.
- Systemic corticosteroid use within 2 months, topical corticosteroid use within 2 weeks, antihistamine use within 1 week, leukotriene antagonist use within one week or immunotherapy within 2 years of baseline visit (or stop at screening)
- Upper respiratory infection within 2 weeks of baseline visit
- Use of tobacco within 1 year of baseline
- Chronic medical condition that could interfere with evaluation of rhinitis endpoints (e.g. allergic skin conditions, active infections, asthma, etc.)
Key Trial Info
Start Date :
January 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04342039
Start Date
January 7 2021
End Date
December 31 2027
Last Update
March 27 2025
Active Locations (1)
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1
University of British Columbia
Vancouver, British Columbia, Canada, V5Z 1M9