Asthma Clinical Trial
— XolairOfficial title:
Immunologic Basis of Anti-IgE Therapy (Study II: On Patients With Asthma)
Verified date | June 2021 |
Source | University of California, Davis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 6 |
Est. completion date | October 17, 2012 |
Est. primary completion date | October 17, 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | Inclusion Criteria: - Mild or moderate persistent asthma - Allergic rhinitis - Atopic dermatitis Exclusion Criteria: - Other lung diseases - Blood clotting disorder - Pregnant or lactating women |
Country | Name | City | State |
---|---|---|---|
United States | UC Davis Department of Dermatology | Sacramento | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Davis |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | FceRI (High Affinity Receptor) Levels at 3 Months | Skin biopsies were collected from patients after 0 (pre), 3 (pos1) and 6 (pos2) months of omalizumab (P11, P36, P42) or placebo (P7 and P38) treatment. The skin was fixed and the paraffin-embedded sections were stained for high affinity receptors. The average numbers of positively stained cells in each field were counted under a microscope at 400X magnification. | 3 months | |
Primary | FceRI (High Affinity Receptor) Levels at 6 Months | Skin biopsies were collected from patients after 0 (pre), 3 (pos1) and 6 (pos2) months of omalizumab (P11, P36, P42) or placebo (P7 and P38) treatment. The skin was fixed and the paraffin-embedded sections were stained for high affinity receptors. The average numbers of positively stained cells in each field were counted under a microscope at 400X magnification. | 6 months | |
Secondary | Total Sera IgE Levels at 6 Months | Total sera IgE levels are increased upon anti-IgE treatment. Sera from each patient were collected every month after omalizumab (P11, P36 and P42) or placebo (P7, P37 and P38) treatment. The sera IgE levels were measured by ELISA using polyclonal goat anti-human IgE as the capture antibody and HRP-goat anti-human IgE as the detection antibody. | 6 months |
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