Kinetics of IgE Memory B Cells, Plasmablasts and Plasma Cells After Whole Lung Allergen Challenge in Mild Asthmatics

This is an interventional basic science trial for Atopic Asthma focused on measuring Allergen Challenge, B cell activation, M1 prime related biomarkers Read More

Inclusion Criteria:

• 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 Criteria:

• 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.