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

• The magnitude of the late asthmatic response, expressed as a percentage change in FEV1 from baseline, and expressed as area under the curve. [ Time Frame: Before inhalation (0hrs) ] [ Designated as safety issue: No ]
• The magnitude of the late asthmatic response, expressed as a percentage change in FEV1 from baseline, and expressed as area under the curve. [ Time Frame: Before inhalation 3 hours ] [ Designated as safety issue: No ]
• The magnitude of the late asthmatic response, expressed as a percentage change in FEV1 from baseline, and expressed as area under the curve. [ Time Frame: 7 hours after challenge ] [ Designated as safety issue: No ]

• The magnitude of allergen-induced airway hyperresponsiveness (methacholine PC20) and inflammation (sputum eosinophils). [ Time Frame: Before inhalation both evaluations (0 hours) ] [ Designated as safety issue: No ]
• The magnitude of allergen-induced airway hyperresponsiveness (methacholine PC20) and inflammation (sputum eosinophils) [ Time Frame: sputum @ 7 hours ] [ Designated as safety issue: No ]
• The magnitude of allergen-induced airway hyperresponsiveness (methacholine PC20) and inflammation (sputum eosinophils) [ Time Frame: 24 hours methacholine and sputum ] [ Designated as safety issue: No ]

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)

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.

• Drug: Fluticasone propionate (Flovent Diskus) 250 mcg
  Flovent Diskus 250 mcg
  Other Name: fluticasone propionate Flovent Diskus250 mcg
• Drug: budesonide 400 mcg
  budesonide 400 mcg
  Other Name: Pulmicort Turbuhaler 200 mcg
• Other: Placebo
  Placebo
  Other Name: Placebo

• Active Comparator: 1
  Fluticasone propionate (Flovent Diskus) 250 mcg
  Intervention: Drug: Fluticasone propionate (Flovent Diskus) 250 mcg
• Active Comparator: 2
  budesonide 200mcg
  Intervention: Drug: budesonide 400 mcg
• Placebo Comparator: 3
  placebo
  Intervention: Other: Placebo

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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