Analysis of Fel d 1-specific T Cells After Airway Allergen Challenge in Asthma

This study is not yet open for participant recruitment.
Verified June 2012 by Hamilton Health Sciences Corporation
Sponsor:
Information provided by (Responsible Party):
Gail Gauvreau, Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier:
NCT01612715
First received: June 4, 2012
Last updated: June 5, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Allergic Asthma.
Other: Segmental Allergen Challenge

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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.

Resource links provided by NLM:


Further study details as provided by Hamilton Health Sciences Corporation:

Primary Outcome Measures:
  • Comparison [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Measurements [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 48
Study Start Date: June 2012
Estimated Study Completion Date: May 2017
Groups/Cohorts Assigned Interventions
Study Population
Mild asthma, cat-allergic, 18-65 years old, males and females will be recruited for the study.
Other: Segmental Allergen Challenge
segmental allergen challenge

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Mild asthma, cat-allergic, 18-65 years old, males and females will be recruited for the study.

Criteria

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 3mm larger than that produced by the negative control.
  4. RAST score of 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*0401, HLA-DRB1*0701,HLA-DRB1*1101, HLA-DRB5*0101. Additional tetramers will expand this list of HLA alleles and improve recruitment.
  6. Methacholine provocative concentration causing a 20% fall in the FEV1 (PC20) <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. 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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01612715

Contacts
Contact: Gail Gauvreau, PhD 905-525-9140 ext 22791 gauvreau@mcmaster.ca

Locations
Canada, Ontario
McMaster University Medical Centre Not yet recruiting
Hamilton, Ontario, Canada, L8S 4K1
Contact: Gail Gauvreau, PhD     905-525-9140 ext 22791     gauvreau@mcmaster.ca    
Sub-Investigator: Paul O'Byrne, MD            
Sub-Investigator: Kieran Killian, MD            
Sub-Investigator: Helen Neighbour, MD            
Sub-Investigator: Mark Larche, PhD            
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Investigators
Principal Investigator: Gail Gauvreau, PhD McMaster University
  More Information

No publications provided

Responsible Party: Gail Gauvreau, Associate Professor, Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier: NCT01612715     History of Changes
Other Study ID Numbers: HHS-12-197
Study First Received: June 4, 2012
Last Updated: June 5, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Hamilton Health Sciences Corporation:
Asthma, allergen challenge, T cells, Fel d 1.

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013