CSL311 and Cell Viability in Asthma

• Status: Completed
• Trial end date: 0000-00-00
• Target enrollment: 10
• Participant gender: Both

Summary

To examine the effect of blocking signaling through the β-chain on viability, activation and differentiation of eosinophils and their progenitors collected from sputum, blood and bone marrow samples collected pre and post-allergen challenge from mild atopic asthmatic subjects.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hamilton Health Sciences Corporation
• Collaborator: CSL Limited
• Last Updated: 2015-03-19

Criteria

Inclusion Criteria:

• Male and female volunteers 18 through 65 years of age.

• 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

• 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.