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

NCT00716963 | Completed Phase 4 Results

• 1 other identifier: AZ2008lr
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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)

Conditions

Mild Intermittent Asthma

Keywords

late allergic response; fluticasone propionate

Outcome Measures

Primary Outcomes (2)

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

  Before inhalation 3 hours

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

  7 hours after challenge

Secondary Outcomes (3)

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

  Before inhalation both evaluations (0 hours)

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

  sputum @ 7 hours

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

  24 hours methacholine and sputum

Study Arms (3)

1

ACTIVE COMPARATOR

Fluticasone propionate (Flovent Diskus) 250 mcg

Drug: Fluticasone propionate (Flovent Diskus) 250 mcg

2

ACTIVE COMPARATOR

budesonide 400mcg

Drug: budesonide 400 mcg

3

PLACEBO COMPARATOR

placebo

Other: Placebo

Interventions

Fluticasone propionate (Flovent Diskus) 250 mcg DRUG

Flovent Diskus 250 mcg

Also known as: fluticasone propionate Flovent Diskus250 mcg

1

budesonide 400 mcg DRUG

budesonide 400 mcg

Also known as: Pulmicort Turbuhaler 200 mcg

2

Placebo OTHER

Placebo

3

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• mild asthma
• nonsmokers
• allergen-induced early and late asthmatic response

You may not qualify if:

• 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

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• AstraZeneca: collaborator

Study Sites (1)

McMaster University

Hamilton, Ontario, L8N 3Z5, Canada

Location

Related Publications (13)

• 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.

  PMID: 17298416 BACKGROUND

• 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.

  PMID: 8912734 BACKGROUND

• 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.

  PMID: 8004297 BACKGROUND

• 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.

  PMID: 17141859 BACKGROUND

• 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.

  PMID: 8509579 BACKGROUND

• 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.

  PMID: 17845579 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 3800152 BACKGROUND

• 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. doi: 10.1111/j.1398-9995.2004.00612.x.

  PMID: 15575931 BACKGROUND

• 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. doi: 10.1164/ajrccm.154.2.8756799.

  PMID: 8756799 BACKGROUND

• O'Byrne PM, Dolovich J, Hargreave FE. Late asthmatic responses. Am Rev Respir Dis. 1987 Sep;136(3):740-51. doi: 10.1164/ajrccm/136.3.740. No abstract available.

  PMID: 3115156 BACKGROUND

• 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. doi: 10.1016/s0091-6749(95)70075-7.

  PMID: 7797787 BACKGROUND

• 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. doi: 10.1016/s0091-6749(99)70115-6.

  PMID: 10400841 BACKGROUND

MeSH Terms

Interventions

Fluticasone; Budesonide

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnenediones; Pregnenes; Pregnanes

Results Point of Contact

• Title: Dr. Gail Gauvreau
• Organization: McMaster University

gauvreau@mcmaster.ca

905-525-9140

Study Officials

• Paul O'Byrne, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Gail Gauvreau, PhD

  McMaster University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2008
• First Posted: July 16, 2008
• Study Start: July 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: December 1, 2008
• Last Updated: May 29, 2018
• Results First Posted: May 15, 2015

Record last verified: 2015-04

Locations

CA (1)