Budesonide for Allergic Disease

(Project Ace Trial)

Overseen By Agnes Yuen, BSc

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of British Columbia

Must not be taking: Systemic corticosteroids, Topical corticosteroids, Antihistamines, Leukotriene antagonists

Disqualifiers: Asthma, Allergic skin conditions, others

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether budesonide, a common nasal spray for allergies, can alter gene behavior affected by allergens and pollution. Scientists believe the spray could reverse some gene changes caused by these environmental factors, potentially improving allergy symptoms. Participants will use either the budesonide spray or a placebo before allergen challenges to assess its effectiveness. This trial suits individuals with a clinical diagnosis of allergic rhinitis (such as dust or pollen allergies) who require treatment for severe nasal symptoms during pollen season. As a Phase 4 trial, this research aims to understand how this FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications before joining the trial. Specifically, you must stop using systemic corticosteroids 2 months before, topical corticosteroids 2 weeks before, antihistamines 1 week before, and leukotriene antagonists 1 week before the baseline visit.

What is the safety track record for budesonide nasal spray?

Research has shown that budesonide nasal spray is generally safe for treating allergy symptoms. One study found that using budesonide once a day improved symptoms like itching and sneezing over 10 days. Another report highlighted that budesonide is effective and well-tolerated, with most people experiencing few or no bothersome side effects. Commonly used for hay fever, budesonide nasal spray can help with an itchy or runny nose and sneezing. While milder options like fluticasone might work better for some symptoms, budesonide remains a reliable choice with a good safety record. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike many standard treatments for allergic diseases that often involve antihistamines or decongestants, budesonide nasal spray is a corticosteroid that directly reduces inflammation in the nasal passages. This targeted delivery method allows it to tackle the root cause of allergy symptoms rather than just masking them. Researchers are particularly excited because budesonide may offer faster and more effective relief from allergy symptoms when faced with allergen and pollution challenges.

What is the effectiveness track record for budesonide nasal spray in treating allergic disease?

Studies have shown that budesonide nasal spray effectively treats symptoms of allergic rhinitis, a common allergy condition. In one study, participants using budesonide reported significant improvements in symptoms like sneezing and itchy noses. Another study found that budesonide relieved nasal symptoms within 12 hours in children with year-round allergies. While budesonide typically reduces swelling, recent research suggests it might also address genetic changes caused by allergens. This indicates that budesonide could not only ease symptoms but also tackle the root causes of allergic reactions. Participants in this trial will receive either budesonide nasal spray or a placebo nasal spray before exposure to a series of allergen and pollution challenges. ^{3 6 7 8 9}

Who Is on the Research Team?

Christopher Carlsten, MD

Principal Investigator

University of British Columbia

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am not currently experiencing symptoms of rhinitis.

A nasal allergen challenge resulting in at least five sneezes and/or a recorded score of >2 in either nasal obstruction or runny nose

I have been diagnosed with allergic rhinitis for at least 2 years.

Exclusion Criteria

Subjects allergic to other allergens occurring during the study period

History of asthma

I am not pregnant or nursing.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Cycle 1

Participants receive either Budesonide or placebo nasal spray, with nasal sampling and symptom questionnaires conducted during in-person visits.

4 weeks

Multiple in-person visits for nasal sampling and questionnaires

Wash-out Period

Participants undergo a wash-out period before starting the second treatment cycle.

2 weeks

Treatment Cycle 2

Participants receive the opposite treatment (Budesonide or placebo) with continued nasal sampling and symptom questionnaires.

4 weeks

Multiple in-person visits for nasal sampling and questionnaires

Follow-up

Participants are monitored for safety and effectiveness after treatment completion.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Budesonide Nasal

Trial Overview 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.

How Is the Trial Designed?

Group I: Budesonide nasal Active Control 1 Intervention

Participants will use budesonide nasal spray before being exposed to a series of allergen and pollution challenges.

Group II: Placebo Placebo Group 1 Intervention

Participants will use a placebo nasal spray before being exposed to a series of allergen and pollution challenges.

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Genome British Columbia

Industry Sponsor

Trials

13

Recruited

223,000+

Johnson & Johnson Consumer Inc. (J&JCI)

Industry Sponsor

Trials

57

Recruited

5,700+

Published Research Related to This Trial

From 2007 to 2022, the FDA received 119 reports regarding the off-label use of budesonide nasal irrigation, primarily from patients.

Adverse events associated with this usage included headaches, difficulty breathing (dyspnea), and blurred vision, highlighting potential safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events associated with budesonide nasal irrigation reported to the US Food and Drug Administration: 2007 to 2022. Rathi, VK., Sawicki, NW., Schlosser, RJ., et al.[2023]

Budesonide, a non-halogenated steroid nasal spray, demonstrated a significant and dose-dependent reduction in nasal symptoms such as blockage, discharge, and sneezing in a study of 36 patients with perennial rhinitis.

Long-term use of budesonide (over two years) showed no serious adverse reactions, and monitoring of hematologic parameters and adrenal function indicated it is safe for extended treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of budesonide in perennial rhinitis. Balle, VH.[2008]

In a study involving 202 children aged 6 to 16 with perennial allergic rhinitis, budesonide aqueous nasal spray at a dose of 128 microg once daily was significantly more effective than placebo in improving nasal airflow and reducing symptoms within the first 12 hours.

Budesonide also led to a decrease in eosinophils, which are associated with allergic reactions, and reduced the need for rescue medication, indicating its efficacy in managing allergic rhinitis in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Budesonide aqueous nasal spray is an effective treatment in children with perennial allergic rhinitis, with an onset of action within 12 hours. Fokkens, WJ., Cserháti, E., dos Santos, JM., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8887983/

The Effectiveness of Budesonide Nasal Irrigation in ... AR patients treated with budesonide nasal irrigation showed significant improvement in all the symptoms listed in the SNOT-22 questionnaire, while patients ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06785662

NCT06785662 | Budesonide Irrigation in Allergic Rhinitis This study aims to evaluate the efficacy of budesonide nasal irrigation in patients with allergic rhinitis, where the use of nasal steroid spray alone was ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8626750/

Efficacy of intranasal fluticasone propionate and budesonide ... Fluticasone propionate was found to be significantly more effective (P < 0.05) than Budesonide in reducing sneezing, nasal itching and majority of symptoms.

4. aacijournal.biomedcentral.com aacijournal.biomedcentral.com/articles/10.1186/s13223-022-00686-y

Intranasal budesonide for rhinitis during a high airborne ... Intranasal budesonide 256 μg once daily improved the total nasal symptoms and itching/sneezing over 10 days in adults with rhinitis triggered/worsened by ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1081120610619552

Budesonide aqueous nasal spray is an effective treatment ... Budesonide aqueous nasal spray, 128 μg once daily, is effective in children with perennial allergic rhinitis. Efficacy was demonstrated within 12 hours.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9207822/

Intranasal budesonide for rhinitis during a high airborne ... Conclusions. Intranasal budesonide 256 µg once daily improved the total nasal symptoms and itching/sneezing over 10 days in adults with rhinitis ...

7. mayoclinic.org mayoclinic.org/drugs-supplements/budesonide-nasal-route/description/drg-20074729

Budesonide (nasal route) - Side effects & dosage Budesonide nasal spray is used to treat an itchy or runny nose, sneezing, or other symptoms caused by hay fever (allergic rhinitis).

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2010/020746s026lbl.pdf

Rhinocort (budesonide) nasal spray label - accessdata.fda.gov If you have allergic rhinitis, your nose becomes. 7 stuffy, runny, and itchy. You may also sneeze a lot. You may. 8 have red, itchy, watery eyes; itchy throat; ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0149291804900501

Once-daily budesonide aqueous nasal spray for allergic ... Intranasal budesonide is effective and well tolerated; budesonide aqueous nasal spray (BANS) offers several advantages of potential importance to patients, ...