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Corticosteroid

Budesonide for Allergic Disease (Project Ace Trial)

Phase 4
Waitlist Available
Led By Christopher Carlsten, MD
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, approximately 4 months.
Awards & highlights

Project Ace Trial Summary

This trial will study whether the administration of budesonide can modify the epigenetic landscape in patients suffering from allergic disease.

Who is the study for?
This trial is for healthy adults aged 18-65 with a clinical diagnosis of allergic rhinitis due to dust mites, grass, or trees. They must have needed treatment during pollen season for the last two years and be able to attend all study visits. Women should not be pregnant/nursing and must use contraception if necessary.Check my eligibility
What is being tested?
The trial is testing whether Budesonide nasal spray can modify the epigenetic changes caused by allergens in patients with allergic rhinitis. It compares Budesonide's effects against a placebo in reversing these genetic expressions influenced by environmental factors.See study design
What are the potential side effects?
Budesonide may cause side effects such as irritation inside the nose, sneezing, nosebleeds, sore throat, or signs of infection like fever or chills. Some people might experience an allergic reaction to the medication.

Project Ace Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not currently experiencing symptoms of rhinitis.
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I have been diagnosed with allergic rhinitis for at least 2 years.
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I've needed medication for severe nasal symptoms during pollen season for the last 2 years.
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I can attend all required appointments.

Project Ace Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, approximately 4 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, approximately 4 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Budesonide affect on allergic rhinitis plus allergen (48 hrs)
Secondary outcome measures
Budesonide affect on allergic rhinitis plus allergen (24 hrs)
Budesonide affect on allergic rhinitis plus pollution (24 hrs)
Budesonide affect on allergic rhinitis plus pollution (48 hrs)
+3 more
Other outcome measures
Change in Peak Nasal Inspiratory Flow (PNIF) (24 hrs)
Change in Peak Nasal Inspiratory Flow (PNIF) (48 hrs)
Change in Total Nasal Symptoms Score (TNSS) (24 hrs)
+2 more

Project Ace Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Budesonide nasalActive Control1 Intervention
Participants will use budesonide nasal spray before being exposed to a series of allergen and pollution challenges.
Group II: PlaceboPlacebo Group1 Intervention
Participants will use a placebo nasal spray before being exposed to a series of allergen and pollution challenges.

Find a Location

Who is running the clinical trial?

University of British ColumbiaLead Sponsor
1,415 Previous Clinical Trials
2,466,996 Total Patients Enrolled
Genome British ColumbiaIndustry Sponsor
12 Previous Clinical Trials
223,222 Total Patients Enrolled
Johnson & Johnson Consumer Inc. (J&JCI)Industry Sponsor
52 Previous Clinical Trials
5,474 Total Patients Enrolled

Media Library

Budesonide Nasal (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT04342039 — Phase 4
Intranasal Steroid Research Study Groups: Budesonide nasal, Placebo
Intranasal Steroid Clinical Trial 2023: Budesonide Nasal Highlights & Side Effects. Trial Name: NCT04342039 — Phase 4
Budesonide Nasal (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04342039 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum number of applicants that will be incorporated into this experiment?

"At the moment, this investigation is not currently accepting participants. The trial was originally announced on July 1st 2021 and has been most recently updated on November 10th 2022. Other studies may be of interest; there are 15 trials for environmental exposures that remain open to recruitment and 31 investigations concerning Budesonide nasal inhalers actively enrolling patients."

Answered by AI

Does this research initiative consider elderly participants?

"Applicants between 18-65 years of age are eligible to join this trial. There is an additional 16 trials available for those under the legal age and 35 separate studies invite individuals older than 65."

Answered by AI

What ailment does Budesonide nasal commonly address?

"Budesonide nasal is used to treat acute coryza, proteinuria, and congestion in the nose; it can also be employed as a treatment for Crohn disease."

Answered by AI

Is it possible to become a participant of this clinical experiment?

"This clinical trial is presently recruiting 20 individuals who have been exposed to environmental allergens and are between 18-65 years old. To qualify for this study, applicants must be asymptomatic at the time of screening; possess a medical diagnosis of allergic rhinitis (dust mite, grass mix or tree mix) for two consecutive years prior; require pharmacological therapy each year in the past two pollen seasons; demonstrate nasal allergen responsiveness via sneezing or obstruction/runny nose scores greater than 2; and meet reproductive health criteria specific to sex if applicable. Additionally, participants should note that they will need to attend specified site"

Answered by AI

Could you elucidate on the prior research done related to Budesonide nasal?

"Currently, 31 clinical trials investigating Budesonide nasal are underway. Of these active studies, 10 of them have reached Phase 3 and 990 sites globally are running the relevant tests. Notably, most of these associated trials can be found in Xi'an, Shaanxi."

Answered by AI

Are investigators still accepting volunteers for this trial?

"The pertinent details available on clinicaltrials.gov suggest that this trial is no longer accepting participants, as the last update was made in November 10th 2022. Although recruitment has closed for this particular study, 46 alternative medical studies are presently recruiting patients."

Answered by AI

Are there any adverse effects associated with Budesonide nasal spray use?

"As this medication has been approved, the safety rating of budesonide nasal was assessed as a 3."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Epigenetic Health Benefits of Budesonide
Christopher Carlsten 2021. "Epigenetic Health Benefits of Budesonide". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04342039.
~3 spots leftby Dec 2024
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