The Safety and Utility of Skin Testing With XOLAIR® (Omalizumab) and Placebo Omalizumab (Formulation Excipients)
Condition: Healthy; Asthma
MeSH terms: Asthma
Intervention: Cohort I; Cohort 2
Intervention description: In sterile water for injection (SWFI), full concentration and 1:1000, 1:100, 1:10 dilutions of 125 mg/mL of standard solution of omalizumab and its excipients. Skin prick test of each dilution concentration of 1:1000, 1:100, 1:10 and full concentration and Intradermal tests of each dilution concentration of 1:1000, 1:100 and 1:10 were followed by 20 minutes of observation. For the skin prick test, participants were tested initially with positive control (histamine 6 mg/mL) and negative control (saline), and with omalizumab and its excipients simultaneously from the lowest concentration.
For the intradermal test, participants were tested initially with positive control (histamine 0.1 mg/mL) and negative control (saline), and with omalizumab and its excipients simultaneously from the lowest concentration.
Dilutions of omalizumab and its excipients were in SWFI.; In a saline solution, full concentration and 1:1000, 1:100, 1:10 dilutions of 125 mg/mL of standard solution of omalizumab and its excipients. Skin prick test of each dilution concentration of 1:1000, 1:100, 1:10 and full concentration and Intradermal tests of each dilution concentration of 1:100,000 and 1:10,000 were followed by 20 minutes of observation.
For the skin prick test, participants were tested initially by positive control (histamine 6 mg/mL) and negative control (saline), and with omalizumab and its excipients simultaneously from the lowest concentration. For the intradermal test, participants were tested initially with positive control (histamine 0.1 mg/mL) and negative control (saline), and with omalizumab and its excipients simultaneously from the lowest concentration.
Dilutions of omalizumab and its excipients were made in saline.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Xolair; Asthma; Skin Tests

Summary:

      This study enrolled 30 healthy volunteers and 30 patients with atopic asthma, for a total of
      60 subjects. The study examined the tolerability of omalizumab and omalizumab excipients in
      two successive cohorts of subjects, healthy volunteers and patients with allergic asthma
      without prior exposure to omalizumab, according to a skin test protocol, consisting of a
      prick skin test and/or intradermal test.
    

Eligibility criteria:

        Inclusion Criteria:

          -  (Applicable to healthy subjects only) Healthy subjects not taking any regular
             prescription medication, without history of allergy, and considered healthy by the
             physician

          -  (Applicable to asthma patients only) Patients with atopic asthma diagnosed by a
             physician with asthma and history of positive skin test(s)

          -  Physical examination findings within normal limits

          -  Body mass index (BMI) between 18 and 30, inclusive

        Exclusion Criteria:

          -  Pregnancy and lactation

          -  Current or previous treatment with a biologic agent (e.g., monoclonal antibody)

          -  Concurrent disease or condition that would interfere, or for which the treatment might
             interfere with the conduct of the study, or that would, in the opinion of the
             investigator, pose an unacceptable risk to individuals in this study

          -  History or symptoms of significant psychiatric disease, including but not limited to,
             depression, schizophrenia, etc.

          -  History of drug abuse

          -  Participation in an investigational drug or device trial within the last 30 days prior
             to screening