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

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:

MedlinePlus related topics: Allergy Asthma

Drug Information available for: Budesonide Fluticasone propionate Fluticasone

U.S. FDA Resources

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

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:

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. Review.

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.

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.

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. Epub 2006 Dec 4.

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.

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. Review.

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

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.

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.

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.

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

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.

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.

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 May 22, 2013