Does Fluticasone Propionate Reduce the Late Allergic Reaction When the Drug is Given Post-allergen?
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|ClinicalTrials.gov Identifier: NCT00716963|
Recruitment Status : Completed
First Posted : July 16, 2008
Results First Posted : May 15, 2015
Last Update Posted : May 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Mild Intermittent Asthma||Drug: Fluticasone propionate (Flovent Diskus) 250 mcg Drug: budesonide 400 mcg Other: Placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||Does a Lipophilic Steroid Inhaled After an Early Allergic Reaction Affect the Late Reaction?|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||November 2008|
|Actual Study Completion Date :||December 2008|
Active Comparator: 1
Fluticasone propionate (Flovent Diskus) 250 mcg
Drug: Fluticasone propionate (Flovent Diskus) 250 mcg
Flovent Diskus 250 mcg
Other Name: fluticasone propionate Flovent Diskus250 mcg
Active Comparator: 2
Drug: budesonide 400 mcg
budesonide 400 mcg
Other Name: Pulmicort Turbuhaler 200 mcg
Placebo Comparator: 3
- The Magnitude of the Early Asthmatic Response, Expressed as a Percentage Change in FEV1. [ Time Frame: Before inhalation 3 hours ]
- The Magnitude of the Late Asthmatic Response, Expressed as a Percentage Change in FEV1. [ Time Frame: 7 hours after challenge ]
- The Magnitude of Allergen-induced Airway Hyperresponsiveness (Methacholine PC20) and Inflammation (Sputum Eosinophils). [ Time Frame: Before inhalation both evaluations (0 hours) ]
- The Magnitude of Allergen-induced Airway Hyperresponsiveness (Methacholine PC20) and Inflammation (Sputum Eosinophils) [ Time Frame: sputum @ 7 hours ]
- The Magnitude of Allergen-induced Airway Hyperresponsiveness (Methacholine PC20) and Inflammation (Sputum Eosinophils) [ Time Frame: 24 hours methacholine and sputum ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00716963
|Hamilton, Ontario, Canada, L8N 3Z5|
|Principal Investigator:||Paul O'Byrne, MD||McMaster University|
|Study Director:||Gail Gauvreau, PhD||McMaster University|