NCT00716963

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Hamilton Health Sciences Corporation · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Mild Intermittent Asthma

Interventions

Type	Name	Description
DRUG	Fluticasone propionate (Flovent Diskus) 250 mcg	Flovent Diskus 250 mcg
DRUG	budesonide 400 mcg	budesonide 400 mcg
OTHER	Placebo	Placebo

Timeline

• Start date: 2008-07-01
• Primary completion: 2008-11-01
• Completion: 2008-12-01
• First posted: 2008-07-16
• Last updated: 2018-05-29
• Results posted: 2015-05-15

Locations

1 site across 1 country: Canada