Does Fluticasone Propionate Reduce the Late Allergic Reaction When the Drug is Given Post-allergen?

Study Overview
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Brief Summary
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The investigators propose a 3-treatment, placebo-controlled, double-dummy, double-blinded, randomized, crossover study in which single doses of placebo, will be compared to Fluticasone propionate (Flovent Diskus) 250 mcg and budesonide 400 mcg administered after allergen challenge, at cessation of the early allergic reaction (at 20% fall in FEV1 from post-allergen peak)

Detailed Description
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The aim of this pilot study is to evaluate whether fluticasone propionate affects the late allergic reaction after a single dose post-allergen challenge administered following cessation of the early allergic reaction. Six subjects with mild asthma will be asked to volunteer for the study.The diagnosis of asthma will be and includes the presence of variable airflow limitation and AHR (PC20 methacholine < 16 mg/mL). Subjects will be asked to participate if they demonstrate an allergen-induced early and late asthmatic response of at least 20% and 15% reduction in FEV1, respectively. The study will consist of 4 periods, composed of a screening allergen period with 3 subsequent allergen challenge/treatment periods. Each period will be separated with a washout of at least 2 weeks. Subjects who demonstrate a dual asthmatic response in the screening period will be selected for randomization to treatment.

Official Title
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Does a Lipophilic Steroid Inhaled After an Early Allergic Reaction Affect the Late Reaction?

Conditions
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Mild Intermittent Asthma

Intervention / Treatment
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* Drug: Fluticasone propionate (Flovent Diskus) 250 mcg
* Drug: budesonide 400 mcg
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: mild asthma nonsmokers allergen-induced early and late asthmatic response Exclusion Criteria: no medication other than infrequent ( < twice weekly) inhaled beta2-agonists not be exposed to sensitizing allergens asthma exacerbation or respiratory tract infection in the past4 weeks

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Active Comparator: 1<br>Fluticasone propionate (Flovent Diskus) 250 mcg | Drug: Fluticasone propionate (Flovent Diskus) 250 mcg<br>* Flovent Diskus 250 mcg<br>* Other names: fluticasone propionate Flovent Diskus250 mcg;|
| Active Comparator: 2<br>budesonide 400mcg | Drug: budesonide 400 mcg<br>* budesonide 400 mcg<br>* Other names: Pulmicort Turbuhaler 200 mcg;|
| Placebo Comparator: 3<br>placebo | Other: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Magnitude of the Early Asthmatic Response, Expressed as a Percentage Change in FEV1. |  | Before inhalation 3 hours | 
| The Magnitude of the Late Asthmatic Response, Expressed as a Percentage Change in FEV1. |  | 7 hours after challenge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Magnitude of Allergen-induced Airway Hyperresponsiveness (Methacholine PC20) and Inflammation (Sputum Eosinophils). |  | Before inhalation both evaluations (0 hours) | 
| The Magnitude of Allergen-induced Airway Hyperresponsiveness (Methacholine PC20) and Inflammation (Sputum Eosinophils) |  | sputum @ 7 hours | 
| The Magnitude of Allergen-induced Airway Hyperresponsiveness (Methacholine PC20) and Inflammation (Sputum Eosinophils) |  | 24 hours methacholine and sputum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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late allergic response, fluticasone propionate