Clinical trial NCT00716963: Does Fluticasone Propionate Reduce the Late Allergic Reaction When the Drug is Given Post-allergen?
Official title: Does a Lipophilic Steroid Inhaled After an Early Allergic Reaction Affect the Late Reaction?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Mild Intermittent Asthma
Keywords: late allergic response
fluticasone propionate
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2008-07-16
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: Inclusion Criteria:

* mild asthma
* nonsmokers
* allergen-induced early and late asthmatic response

Exclusion Criteria:

* 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

Primary outcomes:
measure: The Magnitude of the Early Asthmatic Response, Expressed as a Percentage Change in FEV1.
timeFrame: Before inhalation 3 hours
measure: The Magnitude of the Late Asthmatic Response, Expressed as a Percentage Change in FEV1.
timeFrame: 7 hours after challenge
Secondary outcomes:
measure: The Magnitude of Allergen-induced Airway Hyperresponsiveness (Methacholine PC20) and Inflammation (Sputum Eosinophils).
timeFrame: Before inhalation both evaluations (0 hours)
measure: The Magnitude of Allergen-induced Airway Hyperresponsiveness (Methacholine PC20) and Inflammation (Sputum Eosinophils)
timeFrame: sputum @ 7 hours
measure: The Magnitude of Allergen-induced Airway Hyperresponsiveness (Methacholine PC20) and Inflammation (Sputum Eosinophils)
timeFrame: 24 hours methacholine and sputum
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Paul O'Byrne, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Gail Gauvreau, PhD
role: STUDY_DIRECTOR
References:
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citation: Boulet LP, Gauvreau G, Boulay ME, O'Byrne P, Cockcroft DW; Clinical Investigative Collaboration, Canadian Network of Centers of Excellence AllerGen. The allergen bronchoprovocation model: an important tool for the investigation of new asthma anti-inflammatory therapies. Allergy. 2007 Oct;62(10):1101-10. doi: 10.1111/j.1398-9995.2007.01499.x.
citation: Gauvreau GM, Boulet LP, Hessel EM, Watson RM, Milot J, Coffman RL, et al. A phase 2, randomized, observer-blind, placebo-controlled study of the efficacy, safety and tolerability of inhaled 1018 ISS immunostimulatory oligonucleotide in subjects with mild to moderate asthma. Am.J.Respir.Crit Care Med. 171, A81. 2005. Ref Type: Abstract
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citation: Cockcroft DW, Davis BE, Boulet LP, Deschesnes F, Gauvreau GM, O'Byrne PM, Watson RM. The links between allergen skin test sensitivity, airway responsiveness and airway response to allergen. Allergy. 2005 Jan;60(1):56-9. doi: 10.1111/j.1398-9995.2004.00612.x.
citation: Pizzichini E, Pizzichini MM, Efthimiadis A, Evans S, Morris MM, Squillace D, Gleich GJ, Dolovich J, Hargreave FE. Indices of airway inflammation in induced sputum: reproducibility and validity of cell and fluid-phase measurements. Am J Respir Crit Care Med. 1996 Aug;154(2 Pt 1):308-17. doi: 10.1164/ajrccm.154.2.8756799.
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citation: Inman MD, Watson R, Cockcroft DW, Wong BJ, Hargreave FE, O'Byrne PM. Reproducibility of allergen-induced early and late asthmatic responses. J Allergy Clin Immunol. 1995 Jun;95(6):1191-5. doi: 10.1016/s0091-6749(95)70075-7.
citation: Gauvreau GM, Watson RM, Rerecich TJ, Baswick E, Inman MD, O'Byrne PM. Repeatability of allergen-induced airway inflammation. J Allergy Clin Immunol. 1999 Jul;104(1):66-71. doi: 10.1016/s0091-6749(99)70115-6.