NCT01420003

Brief Summary

The purpose of this study is to characterize the time course of B cell activation after allergen challenge, and more specifically measure the M1 prime related biomarkers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 19, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

March 20, 2015

Status Verified

March 1, 2015

Enrollment Period

2.7 years

First QC Date

August 17, 2011

Last Update Submit

March 19, 2015

Conditions

Atopic Asthma

Keywords

Allergen ChallengeB cell activationM1 prime related biomarkers

Outcome Measures

Primary Outcomes (1)

  • To characterize the time course of B cell activation after allergen challenge, and more specifically measure the M1 prime related biomarkers.

    Within 7 days of allergen challenge

Study Arms (1)

Allergen Challenge

EXPERIMENTAL
Procedure: Bone Marrow AspirationProcedure: Tonsil Biopsy

Interventions

Bone Marrow AspirationPROCEDURE

3 per study

Allergen Challenge
Tonsil BiopsyPROCEDURE

Optional upon completion of study

Allergen Challenge

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female volunteers 18 through 65 years of age.
  • Females must not be actively seeking pregnancy, must be using adequate and effective contraception
  • General good health
  • Mild to moderate, stable, allergic asthma
  • History of episodic wheeze and shortness of breath; FEV1 at baseline at least 70% of the predicted value
  • Able to understand and give written informed consent and has signed a written informed consent form approved by the investigator's REB
  • Positive methacholine challenge
  • Positive skin-prick test to common aeroallergens (including cat, dust mite, grass, pollen)
  • Positive allergen-induced airway bronchoconstriction (a fall in FEV1 of at least 20% from baseline)

You may not qualify if:

  • A worsening of asthma or a respiratory tract infection within 6 weeks preceding study entry
  • History of clinically significant hypotensive episodes or symptoms of fainting, dizziness, or lightheadedness
  • History or symptoms of clinically significant autoimmune disease
  • History of clinically significant hematologic abnormality, including coagulopathy
  • Be pregnant or lactating
  • Use of corticosteroids, immunosuppressives, anticoagulants (warfarin or heparin) within 28 days prior to randomization into the study
  • Use of nonsteroidal anti-inflammatory drugs (NSAIDs) within 48 hours of dosing or aspirin with 7 days of dosing
  • Have chronic use of any other medication for treatment of allergic lung disease other than short- and intermediate-acting ß2-agonists or ipratropium bromide
  • Use of caffeine-containing products or medications for 12 hours or alcohol or over the counter drugs including aspirin, cold and allergy medications for 48 hours or inhaled bronchodilators for 8 hours prior to methacholine and allergen challenges
  • Use of tobacco products of any kind currently or within the previous 12 months, or smoking history \> 10 pack years.
  • Lung disease other than mild to moderate allergic asthma
  • Unwillingness or inability to comply with the study protocol for any other reason.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardio- Respiratory Research Laboratory, Hamilton Health Sciences

Hamilton, Ontario, L8N 3Z5, Canada

Location

Related Publications (17)

  • Bateman ED, Hurd SS, Barnes PJ, Bousquet J, Drazen JM, FitzGerald JM, Gibson P, Ohta K, O'Byrne P, Pedersen SE, Pizzichini E, Sullivan SD, Wenzel SE, Zar HJ. Global strategy for asthma management and prevention: GINA executive summary. Eur Respir J. 2008 Jan;31(1):143-78. doi: 10.1183/09031936.00138707.

    PMID: 18166595BACKGROUND

  • National Asthma Education and Prevention Program. Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma-Summary Report 2007. J Allergy Clin Immunol. 2007 Nov;120(5 Suppl):S94-138. doi: 10.1016/j.jaci.2007.09.043.

    PMID: 17983880BACKGROUND

  • Sears MR, Burrows B, Flannery EM, Herbison GP, Holdaway MD. Atopy in childhood. I. Gender and allergen related risks for development of hay fever and asthma. Clin Exp Allergy. 1993 Nov;23(11):941-8. doi: 10.1111/j.1365-2222.1993.tb00279.x.

    PMID: 10779282BACKGROUND

  • Boulet LP, Cartier A, Thomson NC, Roberts RS, Dolovich J, Hargreave FE. Asthma and increases in nonallergic bronchial responsiveness from seasonal pollen exposure. J Allergy Clin Immunol. 1983 Apr;71(4):399-406. doi: 10.1016/0091-6749(83)90069-6.

    PMID: 6601124BACKGROUND

  • Anto JM, Sunyer J, Rodriguez-Roisin R, Suarez-Cervera M, Vazquez L. Community outbreaks of asthma associated with inhalation of soybean dust. Toxicoepidemiological Committee. N Engl J Med. 1989 Apr 27;320(17):1097-102. doi: 10.1056/NEJM198904273201701.

    PMID: 2710172BACKGROUND

  • O'Hollaren MT, Yunginger JW, Offord KP, Somers MJ, O'Connell EJ, Ballard DJ, Sachs MI. Exposure to an aeroallergen as a possible precipitating factor in respiratory arrest in young patients with asthma. N Engl J Med. 1991 Feb 7;324(6):359-63. doi: 10.1056/NEJM199102073240602.

    PMID: 1987459BACKGROUND

  • Bellomo R, Gigliotti P, Treloar A, Holmes P, Suphioglu C, Singh MB, Knox B. Two consecutive thunderstorm associated epidemics of asthma in the city of Melbourne. The possible role of rye grass pollen. Med J Aust. 1992 Jun 15;156(12):834-7. doi: 10.5694/j.1326-5377.1992.tb136994.x.

    PMID: 1603007BACKGROUND

  • Platts-Mills TA, Tovey ER, Mitchell EB, Moszoro H, Nock P, Wilkins SR. Reduction of bronchial hyperreactivity during prolonged allergen avoidance. Lancet. 1982 Sep 25;2(8300):675-8. doi: 10.1016/s0140-6736(82)90709-7.

    PMID: 6126624BACKGROUND

  • HERXHEIMER H. The late bronchial reaction in induced asthma. Int Arch Allergy Appl Immunol. 1952;3(4):323-8. doi: 10.1159/000227979. No abstract available.

    PMID: 13044326BACKGROUND

  • 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: 3115156BACKGROUND

  • O'Byrne PM, Wood L. Interleukin-5 and allergic inflammation. Clin Exp Allergy. 1999 May;29(5):573-5. doi: 10.1046/j.1365-2222.1999.00556.x. No abstract available.

    PMID: 10231314BACKGROUND

  • Kloek J, Mortaz E, van Ark I, Lilly CM, Nijkamp FP, Folkerts G. Glutathione prevents the early asthmatic reaction and airway hyperresponsiveness in guinea pigs. J Physiol Pharmacol. 2010 Feb;61(1):67-72.

    PMID: 20228417BACKGROUND

  • Becker AB, Black C, Lilley MK, Bajwa K, Ford-Hutchinson AW, Simons FE, Tagari P. Antiasthmatic effects of a leukotriene biosynthesis inhibitor (MK-0591) in allergic dogs. J Appl Physiol (1985). 1995 Feb;78(2):615-22. doi: 10.1152/jappl.1995.78.2.615.

    PMID: 7759431BACKGROUND

  • Coyle AJ, Page CP, Atkinson L, Flanagan R, Metzger WJ. The requirement for platelets in allergen-induced late asthmatic airway obstruction. Eosinophil infiltration and heightened airway responsiveness in allergic rabbits. Am Rev Respir Dis. 1990 Sep;142(3):587-93. doi: 10.1164/ajrccm/142.3.587.

    PMID: 2389910BACKGROUND

  • Hamel R, McFarlane CS, Ford-Hutchinson AW. Late pulmonary responses induced by Ascaris allergen in conscious squirrel monkeys. J Appl Physiol (1985). 1986 Dec;61(6):2081-7. doi: 10.1152/jappl.1986.61.6.2081.

    PMID: 3804916BACKGROUND

  • 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: 8756799BACKGROUND

  • Oliveria JP, Salter BM, MacLean J, Kotwal S, Smith A, Harris JM, Scheerens H, Sehmi R, Gauvreau GM. Increased IgE+ B Cells in Sputum, but Not Blood, Bone Marrow, or Tonsils, after Inhaled Allergen Challenge in Subjects with Asthma. Am J Respir Crit Care Med. 2017 Jul 1;196(1):107-109. doi: 10.1164/rccm.201611-2274LE. No abstract available.

    PMID: 28665197DERIVED

Study Officials

  • Gail M Gauvreau, PhD

    McMaster Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gail Gauvreau, PhD

Study Record Dates

First Submitted

August 17, 2011

First Posted

August 19, 2011

Study Start

November 1, 2011

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

March 20, 2015

Record last verified: 2015-03

Locations

CA(1)