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

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Paul O'Byrne, McMaster University
ClinicalTrials.gov Identifier:
NCT00716963
First received: July 14, 2008
Last updated: April 23, 2013
Last verified: October 2009
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 late asthmatic response, expressed as a percentage change in FEV1 from baseline, and expressed as area under the curve. [ Time Frame: Before inhalation (0hrs) ] [ Designated as safety issue: No ]
  • The magnitude of the late asthmatic response, expressed as a percentage change in FEV1 from baseline, and expressed as area under the curve. [ Time Frame: Before inhalation 3 hours ] [ Designated as safety issue: No ]
  • The magnitude of the late asthmatic response, expressed as a percentage change in FEV1 from baseline, and expressed as area under the curve. [ Time Frame: 7 hours after challenge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The magnitude of allergen-induced airway hyperresponsiveness (methacholine PC20) and inflammation (sputum eosinophils). [ Time Frame: Before inhalation both evaluations (0 hours) ] [ Designated as safety issue: No ]
  • The magnitude of allergen-induced airway hyperresponsiveness (methacholine PC20) and inflammation (sputum eosinophils) [ Time Frame: sputum @ 7 hours ] [ Designated as safety issue: No ]
  • The magnitude of allergen-induced airway hyperresponsiveness (methacholine PC20) and inflammation (sputum eosinophils) [ Time Frame: 24 hours methacholine and sputum ] [ Designated as safety issue: No ]

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 200mcg
Drug: budesonide 400 mcg
budesonide 400 mcg
Other Name: Pulmicort Turbuhaler 200 mcg
Placebo Comparator: 3
placebo
Other: Placebo
Placebo
Other Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00716963

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

Publications:
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
O'byrne PM, Dolovich J, Hargreave FE. Late asthmatic responses. Am Rev Respir Dis 1987 Sep;136(3):740-51.

Responsible Party: Paul O'Byrne, McMaster University
ClinicalTrials.gov Identifier: NCT00716963     History of Changes
Other Study ID Numbers: AZ2008lr
Study First Received: July 14, 2008
Last Updated: April 23, 2013
Health Authority: Canada: Health Canada

Keywords provided by McMaster University:
late allergic response
fluticasone propionate

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases
Budesonide
Fluticasone
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on July 24, 2014