Allergic AsthmaNCT01612715
Analysis of Fel d 1-specific T Cells After Airway Allergen Challenge in Asthma
An observational study of Allergic Asthma, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
Cat allergies are a major trigger of asthma. Therapies are being developed to control the allergic response to cats. We are interested in measuring a type of white blood cell which is linked to cat allergies, which will help us understand how to use new therapies in people who suffer from cat allergies and asthma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Asthma
- What is being tested?
- Segmental Allergen Challenge
- How many people
- 38 participants
- Where
- 1 siteCanada
- Study dates
- 29 Jan 2014to 22 Mar 2018
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Mild asthma, cat-allergic, 18-65 years old, males and females will be recruited for the study.
Who may be able to join
- 1) Male or female, aged 18-65 years. (2) Asthmatic subjects with mild allergic asthma. (3) Positive skin prick test to cat allergen with a wheal diameter at least 2mm l. (4) RAST score of at least 1 or equivalent international units/mL.
- Subjects must express one (or more) of the following Human Leukocyte Antigens (HLA): HLA-DRB1*0101, HLA-DRB1*0301, HLA-DRB1*0401, HLA-DRB1*0405, HLA-DRB1*0701, HLA-DRB1*0901, HLA-DRB1*1001, HLA-DRB1*1101, HLA-DRB1*1301, HLA-DRB1*1401, HLA-DRB5*0101.
- Methacholine provocative concentration causing a 20% fall in the FEV1 (PC20) > 0.125 mg/ml and <16 mg/mL.
- Development of early asthmatic response (≥20% fall in FEV1) with or without a late phase asthmatic response during a screening whole lung allergen challenge.
- (8)Willing and able to provide written informed consent. (9) The subject must be willing and able to comply with the study requirements. (10) If the subject is female and of childbearing potential she must practice an acceptable form of contraception, and produce a negative urine pregnancy test on the Screening Visit and at Days -27 and 1. A female subject may be included without a negative urine pregnancy test if she can document that she is surgically sterile or at least 2 years post-menopausal.
- Normal chest Xray within 1 year of the screening period
Who cannot join
- 1) A history of anaphylaxis to cat allergen. (2) Subjects with an FEV1 <70% of predicted and an FEV1/FVC ratio of < 70. (3) Receipt of any allergen immunotherapy within the last 10 years.
- Use of inhaled or nasal corticosteroids or regular antihistamine use or any regular medication to manage asthma.
- Subjects for whom administration of epinephrine is contra-indicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension).
- Subjects being treated with beta-blockers. (7) Symptoms of a clinically relevant illness, in the Investigator's opinion, within 6 weeks prior to Screening Visit.
- Female subjects who are pregnant, lactating or planning a pregnancy during the study.
- Any clinically relevant abnormalities detected on physical examination. (10) Vital signs (blood pressure, pulse rate, respiratory rate, body temperature) that are outside normal limits, unless the abnormality is considered not to be of clinical relevance by the Investigator.
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- Laboratory values (haematology, biochemistry, urine tests) that are outside the normal ranges, unless the abnormality is considered not to be of clinical relevance by the Investigator.
- History of alcohol or drug abuse that in the opinion of the Principal Investigator could significantly affect the outcomes of this study.
- History of any immunopathological diseases which may confound study outcomes.
- History of vasovagal reaction in the last 10 years associated with venipuncture.
- Received treatment with an investigational drug within 3 months prior to study.
- Unable to communicate or to understand the requirements of the study, which would impair communication between the subject and the Investigator thereby interfering with the informed consent procedure or the gathering of study data.
- A history of any significant disease or disorder (e.g. autoimmune, cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, neoplastic/malignant, psychiatric, major physical impairment, severe atopic dermatitis) which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results of the study, or the subject's ability to participate in the study.
- Positive test results for Hepatitis B, Hepatitis C, HIV other than would be anticipated following vaccination or history of tuberculosis.
- Asthma exacerbation or lower respiratory tract infection in the past 6 weeks.
- Subject who has donated blood (including blood products) or experienced loss of blood ≥ 500 mL within 2 months of study screening (21) Subject who has regularly used nicotine or tobacco containing products (including but not limited to: snuff, chewing tobacco, cigars, cigarettes, pipes, or nicotine patches) during 12 months before enrollment/randomization and during the study. A subject who is a former smoker and has smoked >10 pack years must be excluded.
- Subject is unwilling to avoid rigorous exercise and caffeinated beverages for at least 4 hours before study visits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Fel d 1-specific T Cells After Airway Allergen Challenge in Asthma:Frequency and Phenotype and Trafficking of Cat Allergen-specific T-cells in Blood, Bone Marrow and Bronchoalveolar Lavage Fluid (BALF) Following Segmental Allergen Challenge in Allergic Asthma.
Cat allergies are a major trigger of asthma. Therapies are being developed to control the allergic response to cats. We are interested in measuring a type of white blood cell which is linked to cat allergies, which will help us understand how to use new therapies in people who suffer from cat allergies and asthma. We will study cat-allergic individuals with stable, mild asthma who will be exposed to cat allergens. We will measure various white blood cells, including the cells that are linked to cat allergies, to determine whether the number of these cells changes following cat exposure. These cells will be measured from the blood and bone marrow by removing samples using a needle. These cells will also be measured from the lungs by inserting a bronchoscope into the airways and drawing up fluid containing cells. This study will improve our understanding of the harmful versus protective role of these cat-specific cells, and will allow for development of better drugs for treatment of asthma triggered by cat exposure.
- Conditions
- Allergic Asthma
- Being tested
- Segmental Allergen Challenge
- Keywords
- Asthma, allergen challenge, T cells, Fel d 1.
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Segmental Allergen ChallengeOther
segmental allergen challenge
| Study group | Role | What they receive |
|---|---|---|
| Study Population | Mild asthma, cat-allergic, 18-65 years old, males and females will be recruited for the study. Receives: Other: Segmental Allergen Challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison
The primary outcome for Aim 1 of the study is to compare the number of tetramer+ T cells in the airways of early and dual-responder subjects after segmental allergen challenge. The primary outcome for Aim 2 of the study is to compare the number of tetramer+ T cells in the bone marrow of early and dual-responder subjects after segmental allergen challenge. This will be measured using a panel of antibodies and flow cytometric analysis of cell surface markers.
Measured: 5 Years
Secondary outcomes (1)
Measurements
The secondary outcome is to determine the frequency, memory phenotype and chemokine receptor profile of tetramer+ T cells in the peripheral blood before and after bronchial allergen challenge.
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2012 (estimated)
- Study start29 Jan 2014
- Primary completion22 Mar 2018
- Study completion22 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic AsthmaStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gail Gauvreau, Hamilton Health Sciences Corporation
- Investigators
- Gail Gauvreau, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01612715
- Sponsor's protocol ID
- HHS-12-197
- Status last verified
- Jul 2019
- First submitted
- 4 Jun 2012
- Last updated
- 30 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Fel d 1-specific T Cells After Airway Allergen Challenge in Asthma:Frequency and Phenotype and Trafficking of Cat Allergen-specific T-cells in Blood, Bone Marrow and Bronchoalveolar Lavage Fluid (BALF) Following Segmental Allergen Challenge in Allergic Asthma.
- ClinicalTrials.gov ID
- NCT01612715
- Acronym / sponsor ID
- HHS-12-197
- Conditions
- Allergic Asthma
- Keywords
- Asthma, allergen challenge, T cells, Fel d 1.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- 29 Jan 2014 (actual)
- Primary completion
- 22 Mar 2018 (actual)
- Study completion
- 22 Mar 2018 (actual)
- First posted
- 6 Jun 2012 (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.
Cat allergies are a major trigger of asthma. Therapies are being developed to control the allergic response to cats. We are interested in measuring a type of white blood cell which is linked to cat allergies, which will help us understand how to use new therapies in people who suffer from cat allergies and asthma. We will study cat-allergic individuals with stable, mild asthma who will be exposed to cat allergens. We will measure various white blood cells, including the cells that are linked to cat allergies, to determine whether the number of these cells changes following cat exposure. These cells will be measured from the blood and bone marrow by removing samples using a needle. These cells will also be measured from the lungs by inserting a bronchoscope into the airways and drawing up fluid containing cells. This study will improve our understanding of the harmful versus protective role of these cat-specific cells, and will allow for development of better drugs for treatment of asthma triggered by cat exposure.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Population | – | Other: Segmental Allergen ChallengeMild asthma, cat-allergic, 18-65 years old, males and females will be recruited for the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mild asthma, cat-allergic, 18-65 years old, males and females will be recruited for the study.
Key inclusion criteria (6 listed)
- 1) Male or female, aged 18-65 years. (2) Asthmatic subjects with mild allergic asthma. (3) Positive skin prick test to cat allergen with a wheal diameter at least 2mm l. (4) RAST score of at least 1 or equivalent international units/mL.
- Subjects must express one (or more) of the following Human Leukocyte Antigens (HLA): HLA-DRB1*0101, HLA-DRB1*0301, HLA-DRB1*0401, HLA-DRB1*0405, HLA-DRB1*0701, HLA-DRB1*0901, HLA-DRB1*1001, HLA-DRB1*1101, HLA-DRB1*1301, HLA-DRB1*1401, HLA-DRB5*0101.
- Methacholine provocative concentration causing a 20% fall in the FEV1 (PC20) > 0.125 mg/ml and <16 mg/mL.
- Development of early asthmatic response (≥20% fall in FEV1) with or without a late phase asthmatic response during a screening whole lung allergen challenge.
- (8)Willing and able to provide written informed consent. (9) The subject must be willing and able to comply with the study requirements. (10) If the subject is female and of childbearing potential she must practice an acceptable form of contraception, and produce a negative urine pregnancy test on the Screening Visit and at Days -27 and 1. A female subject may be included without a negative urine pregnancy test if she can document that she is surgically sterile or at least 2 years post-menopausal.
Key exclusion criteria (17 listed)
- 1) A history of anaphylaxis to cat allergen. (2) Subjects with an FEV1 <70% of predicted and an FEV1/FVC ratio of < 70. (3) Receipt of any allergen immunotherapy within the last 10 years.
- Use of inhaled or nasal corticosteroids or regular antihistamine use or any regular medication to manage asthma.
- Subjects for whom administration of epinephrine is contra-indicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension).
- Subjects being treated with beta-blockers. (7) Symptoms of a clinically relevant illness, in the Investigator's opinion, within 6 weeks prior to Screening Visit.
- Female subjects who are pregnant, lactating or planning a pregnancy during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Segmental Allergen Challengesegmental allergen challenge | Other | Study Population |
Primary outcome
Comparison
Time frame: 5 Years
The primary outcome for Aim 1 of the study is to compare the number of tetramer+ T cells in the airways of early and dual-responder subjects after segmental allergen challenge. The primary outcome for Aim 2 of the study is to compare the number of tetramer+ T cells in the bone marrow of early and dual-responder subjects after segmental allergen challenge. This will be measured using a panel of antibodies and flow cytometric analysis of cell surface markers.
1 secondary outcome
Measurements
Time frame: 5 Years
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 30 Jul 2019.
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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.
Gail Gauvreau, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Asthma, run by Hamilton Health Sciences Corporation at 1 site 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 6 inclusion and 17 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 30 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Comparison (time frame: 5 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2019.