Phase 4
Completed N=60
The Safety and Utility of Skin Testing With XOLAIR® (Omalizumab) and Placebo Omalizumab (Formulation Excipients)
Healthy · Asthma
Source: ClinicalTrials.gov NCT00777764 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Feb 2011
Primary outcomePrimary: Number of Participants by of Adverse Events Following a Skin Test Procedure — 1; 3; 0; 0 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants by of Adverse Events Following a Skin Test Procedure |
1; 3; 0; 0; 1; 3 | — |
| PRIMARY Number of Participants Who Experienced a Positive Skin Reaction (Skin Prick Test) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants Who Experienced a Positive Skin Reaction (Intradermal Test in Healthy Volunteers) |
6; 2; 7; 6; 0; 0 | — |
| PRIMARY Number of Participants Who Experienced a Positive Skin Reaction (Intradermal Test in Patients With Allergic Asthma) |
1; 0; 4; 7 | — |
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
Data sourced from ClinicalTrials.gov (NCT00777764). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.