The Effects of Omalizumab (Anti-IgE) on the Late-phase Response to Nasal Allergen Challenge

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT01003301
Phase
PHASE2
Status
Completed

Conditions

  • Cat Allergy

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • Omalizumab — DRUG
    Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks.
  • Placebo — DRUG
    Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks.

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, 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.

Key Dates

Start date
Oct 31, 2009
Status verified
Feb 2014
Primary completion
Dec 31, 2012
Completion
Sep 30, 2013

Study Design

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

Arms

  • Experimental: Omalizumab
    Active treatment: Experimental This arm will receive treatment with omalizumab at the dose FDA-approved for the treatment of allergic asthma.
  • Placebo Comparator: Placebo
    This arm will receive treatment with a placebo injections based on the FDA-approved dosing schedule approved for omalizumab for the treatment of allergic asthma.In general injection number and frequency are determined by a subject's weight and IgE level.

Primary Outcome Measure

The the Size of the 8 Late-phase Skin Response [ Time Frame: Baseline, 2-6 wks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins Asthma and Allergy CenterBaltimoreMaryland21224-

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By research site
Johns Hopkins Asthma and Allergy Center· Baltimore, MD

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