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...
Date First Received: July 14, 2008
Last Updated: July 14, 2008
Verified by: McMaster University, July 2008
Clinical Trial Phase: Phase 4 | Start Date: July 2008
Overall Status: Recruiting
Estimated Enrollment: 6
Brief Summary
Official Title: “Does a Lipophilic Steroid Inhaled After an Early Allergic Reaction Affect the Late Reaction?”
Condition Keyword(s):
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)
Study Type: Interventional
Study Design: Basic Science, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study
Study Primary Completion Date: November 2008
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: Fluticasone propionate (Flovent Diskus) 250 mcg
- Flovent Diskus 250 mcg
- Drug: budesonide 400 mcg
- budesonide 400 mcg
- Other: Placebo
- Placebo
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: 1
- Fluticasone propionate (Flovent Diskus) 250 mcg
- Active Comparator: 2
- budesonide 200mcg
- Placebo Comparator: 3
- placebo
Outcome Measures for this Clinical Trial
Primary 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
Safety Issue?: No
- Time Frame: Before inhalation (0hrs), 3 hours, 7 hours after challenge
Secondary 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
Safety Issue?: No
- Time Frame: Before inhalation both evaluations (0 hours), sputum @ 7 hours and @ 24 hours methacholine and sputum
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 60 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Hamilton Health Sciences
Overall Clinical Trial Officials and Contacts
Paul O'Byrne, MD Principal Investigator McMaster University
Overall Contact: Gail Gauvreau, PhD 905-525-9140 gauvreau@mcmaster.ca
Related Publications
References
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.
Additional Information
Information obtained from ClinicalTrials.gov on November 20, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00716963
Study ID Number: AZ2008lr
ClinicalTrials.gov Identifier: NCT00716963
Health Authority: Canada: Health Canada
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
