CompletedNot Applicable

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

Canada38 participantsStarted 2014-01-29

Plain-language 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. 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

What they're measuring

Comparison

Timeframe: 5 Years

Trial details

NCT IDNCT01612715

SponsorHamilton Health Sciences Corporation

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2018-03-22