McMaster University
Hamilton, Ontario, L8N 3Z5, Canada
NCT Number: NCT00716963
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)
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Notify Me18 year–60 year
All sexes
Interventional
Phase 4
Hamilton, Ontario, L8N 3Z5, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Flovent Diskus 250 mcg
Other names: fluticasone propionate Flovent Diskus250 mcg
budesonide 400 mcg
Other names: Pulmicort Turbuhaler 200 mcg
Placebo
Time frame: Before inhalation 3 hours
Time frame: 7 hours after challenge
Time frame: Before inhalation both evaluations (0 hours)
Time frame: sputum @ 7 hours
Time frame: 24 hours methacholine and sputum
Hamilton Health Sciences Corporation
Other
Does a Lipophilic Steroid Inhaled After an Early Allergic Reaction Affect the Late Reaction?
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