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

Completed

• Conditions: Allergic Asthma
• Interventions: Other: Segmental Allergen Challenge

• Registration Number: NCT01612715
• Lead Sponsor: Hamilton Health Sciences Corporation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-06-04
• Study First Submitted QC: 2012-06-05
• Study First Posted: 2012-06-06
• Study Start: 2014-01-29
• Primary Completion: 2018-03-22
• Study Completion: 2018-03-22
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-29
• Last Update Posted: 2019-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study Population	Segmental Allergen Challenge	Mild asthma, cat-allergic, 18-65 years old, males and females will be recruited for the study.

Primary Outcome Measures

Name	Time	Method
Comparison	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.

Secondary Outcome Measures

Name	Time	Method
Measurements	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.

Trial Locations

Locations (1)

McMaster University Medical Centre; 🇨🇦 Hamilton, Ontario, Canada