Immunologic Basis of Anti-IgE Therapy (Study II: On Patients With Asthma)

Part of paid clinical trials in Sacramento, California.

Sponsor
University of California, Davis
Study ID
NCT00367016
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Omalizumab — DRUG
    Xolair (Omalizumab) will be given by subcutaneous injection according to Ige level and weight calculation.
  • Placebo — DRUG
    Placebo, given by subcutaneous injection.

Study Details

The purpose of this study is to look at measures that will help scientists understand the way Omalizumab, an FDA-approved anti-allergy medication, works.

Key Dates

Start date
Feb 29, 2004
Status verified
Jun 2021
Primary completion
Oct 17, 2012
Completion
Oct 17, 2012

Study Design

Enrollment
6 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Omalizumab
    Subjects will receive subcutaneous Omalizumab for 6 months. Prior to Omalizumab administration, all subjects will undergo screening studies, including spirometry, blood test and skin test. Blood test includes comprehensive metabolic panel, CBC, and total and free IgE levels. Skin test will be done with a panel of 7 common allergens
  • Experimental: Placebo
    Subjects will receive subcutaneous placebo for 6 months. Prior to placebo administration, all subjects will undergo screening studies, including spirometry, blood test and skin test. Blood test includes comprehensive metabolic panel, CBC, and total and free IgE levels. Skin test will be done with a panel of 7 common allergens

Primary Outcome Measure

FcεRI (High Affinity Receptor) Levels at 3 Months [ Time Frame: 3 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
UC Davis Department of DermatologySacramentoCalifornia95816-

Find similar trials in Sacramento, CA

By condition
AsthmaAtopic dermatitis / eczema
By specialty
PulmonologyLung diseaseDermatologyRheumatologyAutoimmune disease
By research site
UC Davis Department of Dermatology· Sacramento, CA

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