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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

July 14, 2008
April 23, 2013
July 2008
November 2008   (final data collection date for primary outcome measure)
  • 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 ]
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), 3 hours, 7 hours after challenge ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00716963 on ClinicalTrials.gov Archive Site
  • 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 ]
The magnitude of allergen-induced airway hyperresponsiveness (methacholine PC20) and inflammation (sputum eosinophils). [ Time Frame: Before inhalation both evaluations (0 hours), sputum @ 7 hours and @ 24 hours methacholine and sputum ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Does Fluticasone Propionate Reduce the Late Allergic Reaction When the Drug is Given Post-allergen?
Does a Lipophilic Steroid Inhaled After an Early Allergic Reaction Affect the Late Reaction?

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)

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Mild Asthma
  • Drug: Fluticasone propionate (Flovent Diskus) 250 mcg
    Flovent Diskus 250 mcg
    Other Name: fluticasone propionate Flovent Diskus250 mcg
  • Drug: budesonide 400 mcg
    budesonide 400 mcg
    Other Name: Pulmicort Turbuhaler 200 mcg
  • Other: Placebo
    Placebo
    Other Name: Placebo
  • Active Comparator: 1
    Fluticasone propionate (Flovent Diskus) 250 mcg
    Intervention: Drug: Fluticasone propionate (Flovent Diskus) 250 mcg
  • Active Comparator: 2
    budesonide 200mcg
    Intervention: Drug: budesonide 400 mcg
  • Placebo Comparator: 3
    placebo
    Intervention: Other: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7
December 2008
November 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00716963
AZ2008lr
No
Paul O'Byrne, McMaster University
Hamilton Health Sciences Corporation
AstraZeneca
Principal Investigator: Paul O'Byrne, MD McMaster University
Study Director: Gail Gauvreau, PhD McMaster University
McMaster University
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP