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

This study has been completed.
Information provided by (Responsible Party):
Gail Gauvreau, McMaster University Identifier:
First received: July 14, 2008
Last updated: April 30, 2015
Last verified: April 2015
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)

Condition Intervention Phase
Mild Asthma
Drug: Fluticasone propionate (Flovent Diskus) 250 mcg
Drug: budesonide 400 mcg
Other: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Does a Lipophilic Steroid Inhaled After an Early Allergic Reaction Affect the Late Reaction?

Resource links provided by NLM:

Further study details as provided by McMaster University:

Primary Outcome Measures:
  • The Magnitude of the Early Asthmatic Response, Expressed as a Percentage Fall in FEV1. [ Time Frame: Before inhalation 3 hours ]
  • The Magnitude of the Late Asthmatic Response, Expressed as a Percentage Fall in FEV1. [ Time Frame: 7 hours after challenge ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 7
Study Start Date: July 2008
Study Completion Date: December 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
budesonide 400mcg
Drug: budesonide 400 mcg
budesonide 400 mcg
Other Name: Pulmicort Turbuhaler 200 mcg
Placebo Comparator: 3
Other: Placebo

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.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00716963

Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8N 3Z5
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Principal Investigator: Paul O'Byrne, MD McMaster University
Study Director: Gail Gauvreau, PhD McMaster University
  More Information

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

Responsible Party: Gail Gauvreau, Associate Professor, McMaster University Identifier: NCT00716963     History of Changes
Other Study ID Numbers: AZ2008lr
Study First Received: July 14, 2008
Results First Received: April 14, 2015
Last Updated: April 30, 2015

Keywords provided by McMaster University:
late allergic response
fluticasone propionate

Additional relevant MeSH terms:
Immune System Diseases
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on April 28, 2017