Table 3. Selected Pediatric Omalizumab Clinical Trials6,7
|
Study
|
Patients
and Baseline Treatment
|
Omalizumab
Study Treatment
|
Primary
Endpoints
|
Results
|
| Milgrom
et al.6 RDBPC |
|
Inhaled BDP and OMX SC 0.016 mg/kg/IgE (IU/mL) for 28 weeks or placebo
|
BDP does reduction, symptoms, spirometry, AE |
|
| Lemanske
et al.7 RDBPC |
|
|
Mean change from baseline in asthma-related QOL scores |
|
| AE=Adverse event, BDP=beclomethasone dipropionate or equivalent inhaled steroid, DBPC=double-blind, placebo-controlled, n=number of patients in study group, OMZ=omalizumab, PAQLQ=Pediatric Asthma Quality of Life Questionnaire, QOL=Quality of Life, RDBPC=randomized, double-blind, placebo-controlled trial, SC=subcutaneous |
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