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

Sponsors and Collaborators:	Hamilton Health Sciences AstraZeneca
Information provided by:	McMaster University
ClinicalTrials.gov Identifier:	NCT00716963

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 IV

MedlinePlus related topics: Allergy Asthma

Drug Information available for: Fluticasone Fluticasone propionate Budesonide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Does a Lipophilic Steroid Inhaled After an Early Allergic Reaction Affect the Late Reaction?

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), 3 hours, 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), sputum @ 7 hours and @ 24 hours methacholine and sputum ] [ Designated as safety issue: No ]

Estimated Enrollment:	6
Study Start Date:	July 2008
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Fluticasone propionate (Flovent Diskus) 250 mcg	Drug: Fluticasone propionate (Flovent Diskus) 250 mcg Flovent Diskus 250 mcg
2: Active Comparator budesonide 200mcg	Drug: budesonide 400 mcg budesonide 400 mcg
3: Placebo Comparator placebo	Other: Placebo 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

Contacts

Contact: Gail Gauvreau, PhD	905-525-9140 ext 22791	gauvreau@mcmaster.ca
Contact: Paul O'Byrne, MD	905-521-2100 ext 76373	obyrnep@mcmaster.ca

Locations

Canada, Ontario
McMaster University	Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Gail Gauvreau, PhD 905-525-9140 ext 22791 gauvreau@mcmaster.ca
Principal Investigator: Paul O'Byrne, MD
Sub-Investigator: Gail Gauvreau, PhD

Sponsors and Collaborators

Hamilton Health Sciences

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.

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:	McMaster University ( Paul O'Byrne )
Study ID Numbers:	AZ2008lr
Study First Received:	July 14, 2008
Last Updated:	July 14, 2008
ClinicalTrials.gov Identifier:	NCT00716963
Health Authority:	Canada: Health Canada

Keywords provided by McMaster University:

late allergic response
fluticasone propionate

Study placed in the following topic categories:

Hypersensitivity
Budesonide
Fluticasone
Asthma

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Immune System Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Anti-Allergic Agents
Glucocorticoids

Hormones
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Dermatologic Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009