Status:
COMPLETED
Kinetics of IgE Memory B Cells, Plasmablasts and Plasma Cells After Whole Lung Allergen Challenge in Mild Asthmatics
Lead Sponsor:
Hamilton Health Sciences Corporation
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Atopic Asthma
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The purpose of this study is to characterize the time course of B cell activation after allergen challenge, and more specifically measure the M1 prime related biomarkers.
Detailed Description
M1 prime is a segment of IgE found only in the membrane form of IgE and not on soluble IgE found in serum. Membrane IgE (and M1prime) is expressed on IgE-switched B cells, IgE-memory B cels, and IgE-p...
Eligibility Criteria
Inclusion
- Male and female volunteers 18 through 65 years of age.
- Females must not be actively seeking pregnancy, must be using adequate and effective contraception
- General good health
- Mild to moderate, stable, allergic asthma
- History of episodic wheeze and shortness of breath; FEV1 at baseline at least 70% of the predicted value
- Able to understand and give written informed consent and has signed a written informed consent form approved by the investigator's REB
- Positive methacholine challenge
- Positive skin-prick test to common aeroallergens (including cat, dust mite, grass, pollen)
- Positive allergen-induced airway bronchoconstriction (a fall in FEV1 of at least 20% from baseline)
Exclusion
- A worsening of asthma or a respiratory tract infection within 6 weeks preceding study entry
- History of clinically significant hypotensive episodes or symptoms of fainting, dizziness, or lightheadedness
- History or symptoms of clinically significant autoimmune disease
- History of clinically significant hematologic abnormality, including coagulopathy
- Be pregnant or lactating
- Use of corticosteroids, immunosuppressives, anticoagulants (warfarin or heparin) within 28 days prior to randomization into the study
- Use of nonsteroidal anti-inflammatory drugs (NSAIDs) within 48 hours of dosing or aspirin with 7 days of dosing
- Have chronic use of any other medication for treatment of allergic lung disease other than short- and intermediate-acting ß2-agonists or ipratropium bromide
- Use of caffeine-containing products or medications for 12 hours or alcohol or over the counter drugs including aspirin, cold and allergy medications for 48 hours or inhaled bronchodilators for 8 hours prior to methacholine and allergen challenges
- Use of tobacco products of any kind currently or within the previous 12 months, or smoking history \> 10 pack years.
- Lung disease other than mild to moderate allergic asthma
- Unwillingness or inability to comply with the study protocol for any other reason.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01420003
Start Date
November 1 2011
End Date
July 1 2014
Last Update
March 20 2015
Active Locations (1)
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1
Cardio- Respiratory Research Laboratory, Hamilton Health Sciences
Hamilton, Ontario, Canada, L8N 3Z5