Mild Intermittent Asthma Clinical Trial
Official title:
Does a Lipophilic Steroid Inhaled After an Early Allergic Reaction Affect the Late Reaction?
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT01591343 -
Safety Study of Depigoid Vaccine Dermatophagoides Pteronyssinus or 50% Dermatophagoides Pteronyssinus / 50% Dermatophagoides Farinae (500 DPP/ml), to Treat Allergic Rhinitis or Rhinoconjunctivitis With or Without Asthma
|
Phase 2 |