A Study of the Effects of Single Dose Corticosteroids on Response to Allergens

Study Overview
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Brief Summary
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This study will investigate whether changes in inflammatory mediators produced by the nose after exposure to an allergen can be used to evaluate the anti-inflammatory effects of novel drugs for the treatment of allergic asthma.

Official Title
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A Randomized Clinical Trial to Study the Effects of Single Dose of Corticosteroid on Response to Nasal Allergen Challenge in Patients

Conditions
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Allergic Rhinitis

Intervention / Treatment
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* Drug: Placebo
* Drug: prednisone
* Drug: prednisone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is allergic to Timothy grass pollen Female patients have a negative pregnancy test and agree to use birth control throughout the study Male patients agree to use birth control throughout the study Patient has been a nonsmoker for at least 6 months Patient agrees to avoid the use of aspirin and other Non-steroidal anti-inflammatory drugs (NSAIDs) throughout study Exclusion Criteria: Patient is breastfeeding Patient has any respiratory disease other than mild stable asthma that does not require treatment Patient consumes more than 3 alcoholic beverages per day Patient consumes more than 6 caffeinated beverages per day Patient has had major surgery or has donated or lost 1 unit of blood within 4 weeks of screening Patient has severe allergies

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: A<br>placebo | Drug: Placebo<br>* Single dose of 5 tablets matching placebo (5 x 0 mg) to prednisone. The washout between treatment periods will be approximately 4 weeks<br>|
| Active Comparator: B<br>10 mg prednisone | Drug: prednisone<br>* Single dose of 5 tablets prednisone totaling 10 mg (3 x 0 mg + 2 x 5 mg). The washout between treatment periods will be approximately 4 weeks.<br>|
| Active Comparator: C<br>25 mg prednisone | Drug: prednisone<br>* Single dose of 5 tablets prednisone totaling 25 mg (5 x 5 mg). The washout between treatment periods will be approximately 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fold Change From Baseline at Hour 8 in Interleukin 5 (IL-5) Concentration | Comparison of the Change in Allergen-induced Interleukin 5 (IL-5) as Measured in Nasal Exudates After a Single Dose of Low or High Dose of Oral Prednisone Relative to Placebo | Baseline and Hour 8 post nasal allergen challenge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline at Hour 8 in the Percent of Total Cells That Are Eosinophils | Comparison of the Change in the Percent of Total Cells That Are Eosinophils Measured in Nasal Lavage After a Single Dose of 10 mg or 25 mg Prednisone Relative to Placebo | Baseline and Hour 8 post nasal allergen challenge |