AsthmaNCT01113697
Genetics of the Early and Late Response to Allergen Challenge
An observational study of Asthma and Allergic Rhinitis, run by University of British Columbia at 5 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Allergic Rhinitis
- How many people
- 520 participants
- Where
- 5 sitesCanada
- Study dates
- Aug 2009to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Asthmatic and/or allergic rhinitis ('hay fever') individuals, 19 years or older
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
McMaster University
Hamilton, Ontario
Queen's University
Kingston, Ontario
Laval University
Québec
University of Saskatchewan
Saskatoon, Saskatchewan
University of British Columbia
Vancouver, British Columbia
About this study
Official title: Molecular Mechanisms Involved in the Early and Late Responses to Allergen Challenge, in Asthmatic and Allergic Rhinitis Cohorts
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.
Read the detailed description
Asthmatic and/or allergic rhinitis ('hay fever') individuals respond differently, but reproducibly, to allergen challenge. Some individuals develop an isolated early response while others also go on to develop a late response. In asthmatic individuals, airway narrowing represents the early phase of the asthmatic response to airway challenge; early phase onset can be detected within ten minutes of allergen inhalation, reaches a maximum within thirty minutes, and typically resolves within three hours. In 50-60% of allergic asthmatic adults, the early response is followed by the late phase asthmatic response, which usually starts between three and four hours after allergen inhalation challenge, and is characterized by cellular inflammation of the airway, increased lung tissue permeability, and mucus secretion. Thus, approximately half of allergic asthmatic subjects are 'dual responders' (developing both an early- and late-phase response following allergen inhalation challenge), 30-40% of allergic asthmatic adults develop an 'isolated early response', and <10% adults show an 'isolated late response'. In any given individual, the pattern of response is generally consistent. In allergic rhinitis individuals challenged by environmental exposure to pollen, equivalent differences exist in the proportions of subjects undergoing isolated early or dual phase nasal responses, with these responses measured by clinical end-points such as common symptoms of allergic rhinitis ('hay fever').
The role that inherited genetic variation might play in these differential early and late responses has so far been unexplored. However, recent experimental data in mouse models provide strong evidence that genetics could play an important role. When a specific intracellular pathway is disrupted by specific mouse gene-knockouts, this leads to the inhibition of a late response to allergen challenge, whilst maintaining the early response. The pathway is known as the Bcl10/Malt1 pathway, and it normally responds to allergen exposure by activating the expression of genes that code for pro-inflammatory proteins. The uncoupling of the late response from the early response suggests a possibility that genetic variation in genes involved in the human Bcl10/Malt1 pathway may influence the nature of the allergic response in humans. We will investigate whether there is a genetic basis for why some individuals develop an isolated early-phase response after allergen challenge whilst other individuals develop early- and late-phase responses (dual response).
We will recruit human allergic subjects undergoing experimentally-controlled allergen challenges. The specific airway responses of these individuals will be carefully and precisely measured, and blood samples will be collected just prior to, and two hours after, the allergen challenge. Due to the uniqueness of our cohorts for novel genetic study, it is logical that we should initially undertake hypothesis-generating experiments. Such experiments will involve the determination of differential changes in genome-wide gene expression in white blood cells and changes in the protein and lipid composition of the blood plasma, post-challenge compared to pre-challenge. We will then formulate and test hypotheses based on the results from these initial studies, as well as the specific following hypothesis: inherited genetic variation within the Bcl10/Malt1 pathway influence the early- and late-phase allergic response to allergen challenge.
Despite tremendous interest, the differences between the pathways leading to the dual response and those leading to the isolated early response are not completely understood. Understanding these differences is important for evaluating allergic diseases such as asthma and allergic rhinitis. In contrast to the more transient isolated early response, development of the late response is associated with the hallmark inflammatory features of chronic allergic disease. The combined cohorts represent a unique resource for the study of a fundamental physiologic response in allergy, and will provide genetic insight into new pathways for pharmacologic targeting in the treatment of chronic asthma and allergic rhinitis.
- Conditions
- Asthma, Allergic Rhinitis
- Keywords
- allergen challenge, blood draw, gene expression analysis, protein analysis, genetics
- Medical subject headings
- Asthma, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observational trial: Early versus Dual Asthmatic Response
Measured: 8 hours post allergen challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2010 (estimated)
- Study startAug 2009
- Primary completionDec 2023
- Study completionDec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 520 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Allergy, Genes and Environment Network (AllerGen), Networks of Centres of Excellence of Canada
- Responsible party
- Principal investigator, Scott Tebbutt, University of British Columbia
- Investigators
- Scott J. Tebbutt, Ph.D, Principal investigator, University of British ColumbiaGail M. Bauvreau, Ph.D, Study director, McMaster UniversityAnne K. Ellis, MD, Study director, Queen's UniversityChristopher R. Carlsten, MD, Study director, University of British ColumbiaDanuta Radzioch, Ph.D, Study director, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01113697
- Sponsor's protocol ID
- H09-02114
- Status last verified
- Dec 2023
- First submitted
- 28 Apr 2010
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22316092Singh 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.
PubMed 23844124Yang 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.
PubMed 28463537Singh 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.
PubMed 29087730
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Mechanisms Involved in the Early and Late Responses to Allergen Challenge, in Asthmatic and Allergic Rhinitis Cohorts
- ClinicalTrials.gov ID
- NCT01113697
- Acronym / sponsor ID
- H09-02114
- Conditions
- Asthma, Allergic Rhinitis
- Keywords
- allergen challenge, blood draw, gene expression analysis, protein analysis, genetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 520 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Allergy, Genes and Environment Network (AllerGen), Networks of Centres of Excellence of Canada
- Study start
- Aug 2009
- Primary completion
- Dec 2023 (actual)
- Study completion
- Dec 2023 (actual)
- First posted
- 30 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Asthmatic and/or allergic rhinitis ('hay fever') individuals respond differently, but reproducibly, to allergen challenge. Some individuals develop an isolated early response while others also go on to develop a late response. In asthmatic individuals, airway narrowing represents the early phase of the asthmatic response to airway challenge; early phase onset can be detected within ten minutes of allergen inhalation, reaches a maximum within thirty minutes, and typically resolves within three hours. In 50-60% of allergic asthmatic adults, the early response is followed by the late phase asthmatic response, which usually starts between three and four hours after allergen inhalation challenge, and is characterized by cellular inflammation of the airway, increased lung tissue permeability, and mucus secretion. Thus, approximately half of allergic asthmatic subjects are 'dual responders' (developing both an early- and late-phase response following allergen inhalation challenge), 30-40% of allergic asthmatic adults develop an 'isolated early response', and <10% adults show an 'isolated late response'. In any given individual, the pattern of response is generally consistent. In allergic rhinitis individuals challenged by environmental exposure to pollen, equivalent differences exist in the proportions of subjects undergoing isolated early or dual phase nasal responses, with these responses measured by clinical end-points such as common symptoms of allergic rhinitis ('hay fever').
The role that inherited genetic variation might play in these differential early and late responses has so far been unexplored. However, recent experimental data in mouse models provide strong evidence that genetics could play an important role. When a specific intracellular pathway is disrupted by specific mouse gene-knockouts, this leads to the inhibition of a late response to allergen challenge, whilst maintaining the early response. The pathway is known as the Bcl10/Malt1 pathway, and it normally responds to allergen exposure by activating the expression of genes that code for pro-inflammatory proteins. The uncoupling of the late response from the early response suggests a possibility that genetic variation in genes involved in the human Bcl10/Malt1 pathway may influence the nature of the allergic response in humans. We will investigate whether there is a genetic basis for why some individuals develop an isolated early-phase response after allergen challenge whilst other individuals develop early- and late-phase responses (dual response).
We will recruit human allergic subjects undergoing experimentally-controlled allergen challenges. The specific airway responses of these individuals will be carefully and precisely measured, and blood samples will be collected just prior to, and two hours after, the allergen challenge. Due to the uniqueness of our cohorts for novel genetic study, it is logical that we should initially undertake hypothesis-generating experiments. Such experiments will involve the determination of differential changes in genome-wide gene expression in white blood cells and changes in the protein and lipid composition of the blood plasma, post-challenge compared to pre-challenge. We will then formulate and test hypotheses based on the results from these initial studies, as well as the specific following hypothesis: inherited genetic variation within the Bcl10/Malt1 pathway influence the early- and late-phase allergic response to allergen challenge.
Despite tremendous interest, the differences between the pathways leading to the dual response and those leading to the isolated early response are not completely understood. Understanding these differences is important for evaluating allergic diseases such as asthma and allergic rhinitis. In contrast to the more transient isolated early response, development of the late response is associated with the hallmark inflammatory features of chronic allergic disease. The combined cohorts represent a unique resource for the study of a fundamental physiologic response in allergy, and will provide genetic insight into new pathways for pharmacologic targeting in the treatment of chronic asthma and allergic rhinitis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Asthmatic and/or allergic rhinitis ('hay fever') individuals, 19 years or older
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Observational trial: Early versus Dual Asthmatic Response
Time frame: 8 hours post allergen challenge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Results publication: PubMed 22316092Kam 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.
- Results publication: PubMed 23844124Singh 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.
- Results publication: PubMed 28463537Yang 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.
- Results publication: PubMed 29087730Singh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott J. Tebbutt, Ph.D principal investigator
University of British Columbia
Gail M. Bauvreau, Ph.D study director
McMaster University
Anne K. Ellis, MD study director
Queen's University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Allergic Rhinitis, run by University of British Columbia at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observational trial: Early versus Dual Asthmatic Response (time frame: 8 hours post allergen challenge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01113697, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.