Nasal Allergen Challenge - Reproducibility of Biomarkers and Effect of Topical Steroid Treatment

Study Overview
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Brief Summary
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Subjects with allergic asthma developing the required nasal symptoms in response to nasal allergen titration during a screening period will be randomized 1:1 to one of 2 cohorts. All subjects will have repeated nasal challenges with allergen. One cohort will have nasal saline challenge as control. One cohort will have intranasal corticosteroid intervention.

Detailed Description
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Eligible subjects will be randomized 1:1 to Cohort A or Cohort B. Each cohort will undergo 3 nasal challenges, each separated by 3 weeks. Cohort A will undergo 2 nasal allergen challenges, and 1 nasal diluent challenge. TNSS, PNIF, spirometry, and samples of blood, urine and nasal secretions will be collected until 24h post-challenge to assess reproducibility. Cohort B will undergo 3 nasal allergen challenges; one of the challenge will be conducted after 14 days treatment with placebo, and one challenge will be conducted after 14 days treatment with triamcinolone acetonide aqueous nasal spray at a dose of 220 mcg administered twice daily for a total daily dose of 440 mcg. TNSS, PNIF, spirometry, and samples of blood, urine, nasal secretions will be collected until 24h post-challenge to determine reproducibility, and nasal tissue will be collected 24h post-challenge to determine effect of steroid treatment.

Official Title
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Nasal Allergen Challenge - Reproducibility of Biomarkers and Effect of Topical Steroid Treatment

Conditions
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Allergic Asthma

Intervention / Treatment
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* Drug: Triamcinolone Acetonide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: allergic rhinitis + mild asthma Exclusion Criteria: other respiratory disease any medication for treatment of asthma/allergic rhinitis with the exception of infrequent beta-2 agonist.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>0.9% normal saline administered twice daily for 14 days | Drug: Placebo<br>* twice daily for 14 days<br>* Other names: 0.9% Normal Saline;|
| Experimental: Intranasal Corticosteroid<br>Triamcinolone acetonide aqueous nasal spray at a dose of 220 mcg administered twice daily (for a total daily dose of 440 mcg) for 14 days | Drug: Triamcinolone Acetonide<br>* 220 mcg administered twice daily for 14 days<br>* Other names: Nasacort;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cellular inflammation | Nasal eosinophils | 24 hours after nasal allergen challenge |