Does Fluticasone Propionate Reduce the Late Allergic Reaction When the Drug is Given Post-allergen?
- Conditions
- Mild Intermittent Asthma
- Interventions
- Registration Number
- NCT00716963
- Lead Sponsor
- Hamilton Health Sciences Corporation
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7
- mild asthma
- nonsmokers
- allergen-induced early and late asthmatic response
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 Fluticasone propionate (Flovent Diskus) 250 mcg Fluticasone propionate (Flovent Diskus) 250 mcg 2 budesonide 400 mcg budesonide 400mcg 3 Placebo placebo
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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) 24 hours methacholine and sputum
Trial Locations
- Locations (1)
McMaster University
🇨🇦Hamilton, Ontario, Canada