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

Primary Purpose

Mild Intermittent Asthma

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Fluticasone propionate (Flovent Diskus) 250 mcg
budesonide 400 mcg
Placebo
Sponsored by
Hamilton Health Sciences Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Mild Intermittent Asthma focused on measuring late allergic response, fluticasone propionate

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • McMaster University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

1

2

3

Arm Description

Fluticasone propionate (Flovent Diskus) 250 mcg

budesonide 400mcg

placebo

Outcomes

Primary Outcome Measures

The Magnitude of the Early Asthmatic Response, Expressed as a Percentage Change in FEV1.
The Magnitude of the Late Asthmatic Response, Expressed as a Percentage Change in FEV1.

Secondary Outcome Measures

The Magnitude of Allergen-induced Airway Hyperresponsiveness (Methacholine PC20) and Inflammation (Sputum Eosinophils).
The Magnitude of Allergen-induced Airway Hyperresponsiveness (Methacholine PC20) and Inflammation (Sputum Eosinophils)
The Magnitude of Allergen-induced Airway Hyperresponsiveness (Methacholine PC20) and Inflammation (Sputum Eosinophils)

Full Information

First Posted
July 14, 2008
Last Updated
March 15, 2018
Sponsor
Hamilton Health Sciences Corporation
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00716963
Brief Title
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

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hamilton Health Sciences Corporation
Collaborators
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Intermittent Asthma
Keywords
late allergic response, fluticasone propionate

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Fluticasone propionate (Flovent Diskus) 250 mcg
Arm Title
2
Arm Type
Active Comparator
Arm Description
budesonide 400mcg
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
Fluticasone propionate (Flovent Diskus) 250 mcg
Other Intervention Name(s)
fluticasone propionate Flovent Diskus250 mcg
Intervention Description
Flovent Diskus 250 mcg
Intervention Type
Drug
Intervention Name(s)
budesonide 400 mcg
Other Intervention Name(s)
Pulmicort Turbuhaler 200 mcg
Intervention Description
budesonide 400 mcg
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
The Magnitude of the Early Asthmatic Response, Expressed as a Percentage Change in FEV1.
Time Frame
Before inhalation 3 hours
Title
The Magnitude of the Late Asthmatic Response, Expressed as a Percentage Change in FEV1.
Time Frame
7 hours after challenge
Secondary Outcome Measure Information:
Title
The Magnitude of Allergen-induced Airway Hyperresponsiveness (Methacholine PC20) and Inflammation (Sputum Eosinophils).
Time Frame
Before inhalation both evaluations (0 hours)
Title
The Magnitude of Allergen-induced Airway Hyperresponsiveness (Methacholine PC20) and Inflammation (Sputum Eosinophils)
Time Frame
sputum @ 7 hours
Title
The Magnitude of Allergen-induced Airway Hyperresponsiveness (Methacholine PC20) and Inflammation (Sputum Eosinophils)
Time Frame
24 hours methacholine and sputum

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul O'Byrne, MD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gail Gauvreau, PhD
Organizational Affiliation
McMaster University
Official's Role
Study Director
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
17298416
Citation
Bousquet J, Clark TJ, Hurd S, Khaltaev N, Lenfant C, O'byrne P, Sheffer A. GINA guidelines on asthma and beyond. Allergy. 2007 Feb;62(2):102-12. doi: 10.1111/j.1398-9995.2006.01305.x.
Results Reference
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PubMed Identifier
8912734
Citation
Gauvreau GM, Doctor J, Watson RM, Jordana M, O'Byrne PM. Effects of inhaled budesonide on allergen-induced airway responses and airway inflammation. Am J Respir Crit Care Med. 1996 Nov;154(5):1267-71. doi: 10.1164/ajrccm.154.5.8912734.
Results Reference
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PubMed Identifier
8004297
Citation
Paggiaro PL, Dente FL, Morelli MC, Bancalari L, Di Franco A, Giannini D, Vagaggini B, Bacci E, Fabbri LM, Giuntini C. Postallergen inhaled budesonide reduces late asthmatic response and inhibits the associated increase of airway responsiveness to methacholine in asthmatics. Am J Respir Crit Care Med. 1994 Jun;149(6):1447-51. doi: 10.1164/ajrccm.149.6.8004297.
Results Reference
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PubMed Identifier
17141859
Citation
Duong M, Gauvreau G, Watson R, Obminski G, Strinich T, Evans M, Howie K, Killian K, O'Byrne PM. The effects of inhaled budesonide and formoterol in combination and alone when given directly after allergen challenge. J Allergy Clin Immunol. 2007 Feb;119(2):322-7. doi: 10.1016/j.jaci.2006.10.018. Epub 2006 Dec 4.
Results Reference
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PubMed Identifier
8509579
Citation
Cockcroft DW, McParland CP, O'Byrne PM, Manning P, Friend JL, Rutherford BC, Swystun VA. Beclomethasone given after the early asthmatic response inhibits the late response and the increased methacholine responsiveness and cromolyn does not. J Allergy Clin Immunol. 1993 Jun;91(6):1163-8. doi: 10.1016/0091-6749(93)90319-b.
Results Reference
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PubMed Identifier
17845579
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.
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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
Results Reference
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PubMed Identifier
3800152
Citation
Cockcroft DW, Murdock KY, Kirby J, Hargreave F. Prediction of airway responsiveness to allergen from skin sensitivity to allergen and airway responsiveness to histamine. Am Rev Respir Dis. 1987 Jan;135(1):264-7. doi: 10.1164/arrd.1987.135.1.264.
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PubMed Identifier
15575931
Citation
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PubMed Identifier
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Citation
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Citation
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Does Fluticasone Propionate Reduce the Late Allergic Reaction When the Drug is Given Post-allergen?

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