- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01612715
Analysis of Fel d 1-specific T Cells After Airway Allergen Challenge in Asthma
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada, L8S 4K1
- McMaster University Medical Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
INCLUSION CRITERIA:
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.
(5) 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.
(6) Methacholine provocative concentration causing a 20% fall in the FEV1 (PC20) > 0.125 mg/ml and <16 mg/mL.
(7) 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.
(11) Normal chest Xray within 1 year of the screening period
EXCLUSION CRITERIA
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.
(4) Use of inhaled or nasal corticosteroids or regular antihistamine use or any regular medication to manage asthma.
(5) Subjects for whom administration of epinephrine is contra-indicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension).
(6) 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.
(8) Female subjects who are pregnant, lactating or planning a pregnancy during the study.
(9) 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.
(11) 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.
(12) History of alcohol or drug abuse that in the opinion of the Principal Investigator could significantly affect the outcomes of this study.
(13) History of any immunopathological diseases which may confound study outcomes.
(14) History of vasovagal reaction in the last 10 years associated with venipuncture.
(15) Received treatment with an investigational drug within 3 months prior to study.
(16) 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.
(17) 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.
(18) Positive test results for Hepatitis B, Hepatitis C, HIV other than would be anticipated following vaccination or history of tuberculosis.
(19) Asthma exacerbation or lower respiratory tract infection in the past 6 weeks.
(20) 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.
(22) Subject is unwilling to avoid rigorous exercise and caffeinated beverages for at least 4 hours before study visits.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Study Population
Mild asthma, cat-allergic, 18-65 years old, males and females will be recruited for the study.
|
segmental allergen challenge
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
5 Years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurements
Time Frame: 5 Years
|
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.
|
5 Years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HHS-12-197
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Allergic Asthma
-
University of ZurichUniversity of AarhusActive, not recruitingAllergic Rhinitis Due to Grass Pollen | Allergic Rhinitis | Rhinitis, Allergic, Seasonal | Allergic Asthma | Rhinitis; Allergic, With AsthmaSwitzerland
-
Children's Mercy Hospital Kansas CityCompletedAsthma | Allergic Asthma | Non-allergic AsthmaUnited States
-
ALK-Abelló A/SCompletedAllergic Rhinitis Due to House Dust Mite | Allergic Asthma Due to Dermatophagoides Farinae | Allergic Asthma Due to Dermatophagoides PteronyssinusPoland, United Kingdom, Spain, United States, Russian Federation, Hungary, France, Bulgaria, Germany
-
ALK-Abelló A/SITEC ServicesCompletedAllergic Rhinitis Due to House Dust Mite | Allergic Asthma Due to Dermatophagoides Farinae | Allergic Asthma Due to Dermatophagoides PteronyssinusFrance
-
The Cleveland ClinicEnrolling by invitation
-
Leti Pharma GmbHCompletedAllergic Asthma | Allergic RhinoconjunctivitisGermany
-
University Hospital, AkershusOslo University Hospital; ImmunoPharma ASRecruitingAllergic Asthma | Allergic Rhinoconjunctivitis | Immune ToleranceNorway
-
Inmunotek S.L.BioClever 2005 S.L.; NTS hub S.LNot yet recruitingPerennial Allergic Rhinitis | Allergic Asthma | Allergic Rhinoconjunctivitis | House Dust Mite AllergySpain
-
Johann Wolfgang Goethe University HospitalCompleted
-
University of North Carolina, Chapel HillNational Institutes of Health (NIH)TerminatedMild Allergic Rhinitis | Mild Allergic Rhinitis With Mild AsthmaUnited States
Clinical Trials on Segmental Allergen Challenge
-
JOSALYN CHOMassachusetts General HospitalActive, not recruitingAllergic Rhinitis | Allergic Conjunctivitis | Allergic Asthma | Allergy to Cats | Allergy to Dust MitesUnited States
-
University of Wisconsin, MadisonNational Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health...Completed
-
University of Wisconsin, MadisonNational Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health...Completed
-
Hamilton Health Sciences CorporationCompleted
-
Medical College of WisconsinMerck Sharp & Dohme LLCCompletedNasal Allergies
-
Laval UniversityUnknownAsthma | Allergic RhinitisCanada
-
McMaster UniversitySt. Joseph's Healthcare HamiltonUnknown
-
Royal Brompton & Harefield NHS Foundation TrustRecruiting
-
McMaster UniversitySt. Joseph's Healthcare HamiltonUnknown
-
Laval UniversityAllerGen NCE Inc.Completed