Cat Allergy Clinical Trial
Official title:
The Effects of Omalizumab on the Late-phase Response to Nasal Allergen Challenge
This research is being done to study the effects of the drug omalizumab (Xolair) in people
with cat allergies. The investigators will use omalizumab to study changes in the cells in
the nose, cells in the blood and cells in the skin that cause allergies. The investigators
will compare the changes in the nose to changes in the skin and blood cells.
Objective: To test the hypothesis that treatment with omalizumab will decrease the nasal
allergen challenge late-phase eosinophil count in nasal brushings at the time when blood
basophils have become hypo-responsive to in vitro allergen exposure.
This is a randomized, placebo-controlled, double-blind, parallel group design study that
includes 3.5 months of treatment with omalizumab or placebo and a 3 month follow-up. All
subjects will be cat allergic.
Twenty four subjects (1:1 randomization) will undergo a cat allergen nasal challenge prior
to treatment and another challenge after 2 months of treatment or when their blood basophils
become hyporesponsive to cat allergen in vitro. A second group of 10 subjects (1:1
active:placebo), will not undergo nasal challenges. This group will participate in an
ancillary study in which the effects of omalizumab on gene expression profiles in peripheral
blood cells will be studied.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science
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