The Effect of Omalizumab on Responses to Cat Allergen Challenge

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT00604786
Status
Completed

Conditions

  • Allergic Rhinitis

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • omalizumab — DRUG
    Dosing is based on IgE level and weight given every 2 or 4 weeks
  • placebo — DRUG
    Dosing is based on IgE level and weight given every 2 or 4 weeks

Study Details

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, skin and blood that cause allergies. The investigators predict that cells in the blood will be effected before cells in the nose or skin.

Key Dates

Start date
Jul 31, 2007
Status verified
Apr 2017
Primary completion
Jan 31, 2009
Completion
Jan 31, 2009

Study Design

Enrollment
18 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Omalizumab subcutaneous
    This active are will receive treatment with omalizumab subcutaneously at the dose currently FDA-approved for the treatment of allergic asthma. There is a weight and IgE based dosing table in the and subjects receive therapy by subcutaneous injection every 2 or 4 weeks. The lower range of dosing is 150 mg q 4weeks ( one injection) with the upper range 375 mg every 2 weeks ( three injections). The dosing is based on IgE levels and IGE and is given by subcutaneous injection every 2 to 4 weeks
  • Placebo Comparator: Placebo Subcutaneous
    This placebo arm will receive identical treatment with placebo injections subcutaneously at the dose currently FDA-approved for the treatment of allergic asthma. There is a weight and IgE based dosing table in the and subjects receive therapy by subcutaneous injection every 2 or 4 weeks. The lower range of dosing is 150 mg q 4weeks ( one injection) with the upper range 375 mg every 2 weeks ( three injections). The dosing is based on IgE levels and IGE and is given by subcutaneous injection every 2 to 4 weeks.

Primary Outcome Measure

Change in Basophil Surface IgE [ Time Frame: Change from baseline to 3.5 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins Asthma and Allergy CenterBaltimoreMaryland21224-

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Johns Hopkins Asthma and Allergy Center· Baltimore, MD

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