NCT01113697

Brief Summary

The investigators are investigating the early and late responses to allergen challenge. The research participants who the investigators will study (from three cohorts) will be part of independently-approved studies involving allergen challenge. Due to the uniqueness of the cohorts for novel genetic study, it is logical that the investigators should initially undertake hypothesis-generating experiments. The investigators will obtain blood samples from the participants, both pre-challenge and post-challenge. The investigators will determine gene expression and protein differences between these samples, and investigate if there are inherited genetic differences between individuals that may predict their specific responses to allergens.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
520

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2009

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

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

Study Start

First participant enrolled

August 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 30, 2010

Completed
13.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

December 6, 2023

Status Verified

December 1, 2023

Enrollment Period

14.3 years

First QC Date

April 28, 2010

Last Update Submit

December 4, 2023

Conditions

Keywords

allergen challengeblood drawgene expression analysisprotein analysisgenetics

Outcome Measures

Primary Outcomes (1)

  • Observational trial: Early versus Dual Asthmatic Response

    8 hours post allergen challenge

Study Arms (3)

Clinical Investigator Collaborative (CIC) Asthma study cohort

Participants will be healthy volunteer research subjects with allergic asthma who will have an allergen inhalation challenge at CIC sites across Canada.

Western Red Cedar Asthma study cohort

Participants will be volunteer research subjects with Western Red Cedar asthma, who will have a plicatic acid inhalation challenge at The Lung Centre at Vancouver General Hospital.

Environmental Exposure Unit (EEU), Kingston General Hospital

Subjects will be over 19 years of age so that they qualify for studies involving allergen challenge.

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Asthmatic and/or allergic rhinitis ('hay fever') individuals, 19 years or older

You may qualify if:

  • participants will be healthy volunteer research subjects with allergic asthma, or
  • participants will be volunteer research subjects with Western Red Cedar asthma, or
  • participants will be healthy volunteer research subjects with allergic rhinitis (hay fever)
  • all participants will be over 19 years of age so that they qualify for studies involving allergen challenge

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of British Columbia

Vancouver, British Columbia, Canada

Location

McMaster University

Hamilton, Ontario, Canada

Location

Queen's University

Kingston, Ontario, Canada

Location

University of Saskatchewan

Saskatoon, Saskatchewan, Canada

Location

Laval University

Québec, Canada

Location

Related Publications (4)

  • Kam SH, Singh A, He JQ, Ruan J, Gauvreau GM, O'Byrne PM, Fitzgerald JM, Tebbutt SJ. Peripheral blood gene expression changes during allergen inhalation challenge in atopic asthmatic individuals. J Asthma. 2012 Apr;49(3):219-26. doi: 10.3109/02770903.2011.654300. Epub 2012 Feb 9.

  • Singh A, Yamamoto M, Kam SH, Ruan J, Gauvreau GM, O'Byrne PM, FitzGerald JM, Schellenberg R, Boulet LP, Wojewodka G, Kanagaratham C, De Sanctis JB, Radzioch D, Tebbutt SJ. Gene-metabolite expression in blood can discriminate allergen-induced isolated early from dual asthmatic responses. PLoS One. 2013 Jul 2;8(7):e67907. doi: 10.1371/journal.pone.0067907. Print 2013.

  • Yang CX, Singh A, Kim YW, Conway EM, Carlsten C, Tebbutt SJ. Diagnosis of Western Red Cedar Asthma Using a Blood-based Gene Expression Biomarker Panel. Am J Respir Crit Care Med. 2017 Dec 15;196(12):1615-1617. doi: 10.1164/rccm.201608-1740LE. No abstract available.

  • Singh A, Shannon CP, Kim YW, Yang CX, Balshaw R, Cohen Freue GV, Gauvreau GM, FitzGerald JM, Boulet LP, O'Byrne PM, Tebbutt SJ. Novel Blood-based Transcriptional Biomarker Panels Predict the Late-Phase Asthmatic Response. Am J Respir Crit Care Med. 2018 Feb 15;197(4):450-462. doi: 10.1164/rccm.201701-0110OC.

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, plasma, white cells

MeSH Terms

Conditions

AsthmaRhinitis, Allergic

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesRhinitisNose DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Scott J. Tebbutt, Ph.D

    University of British Columbia

    PRINCIPAL INVESTIGATOR
  • Gail M. Bauvreau, Ph.D

    McMaster University

    STUDY DIRECTOR
  • Anne K. Ellis, MD

    Queen's University

    STUDY DIRECTOR
  • Christopher R. Carlsten, MD

    University of British Columbia

    STUDY DIRECTOR
  • Danuta Radzioch, Ph.D

    McGill University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 28, 2010

First Posted

April 30, 2010

Study Start

August 1, 2009

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

December 6, 2023

Record last verified: 2023-12

Locations