Trials Sponsors Conditions Drugs Pricing

Conditions

Allergic Asthma

Keywords

Asthma, allergen challenge, T cells, Fel d 1.

Outcome Measures

Primary Outcomes (1)

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.
5 Years

Secondary Outcomes (1)

Measurements
5 Years

Study Arms (1)

Study Population

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

Other: Segmental Allergen Challenge

Interventions

Segmental Allergen ChallengeOther

segmental allergen challenge

Study Population

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

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

You may qualify if:

\) 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.

Sponsors & Collaborators

Hamilton Health Sciences Corporation
Otherlead

Study Sites (1)

McMaster University Medical Centre

Hamilton, Ontario, L8S 4K1, Canada

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

Gail Gauvreau, PhD
McMaster University
PRINCIPAL INVESTIGATOR

Enrollment

38 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: CASE ONLY
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Associate Professor

Study Record Dates

First Submitted

June 4, 2012

First Posted

June 6, 2012

Study Start

January 29, 2014

Actual (reported)

You may not qualify if:

\) 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.
+2 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Study Population

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Study Population

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations