At a glance
ClinicalIndex Comparison Record- ✓Asthma diagnosed >1 year prior to entry, or diagnosed <1 year prior but with symptoms for >1 year
- ✓Currently on long-term asthma control therapy OR have persistent asthma symptoms OR have uncontrolled disease
- ✓Positive skin prick test to at least one perennial allergen (dust mite, cockroach, mold, cat, dog, rat, mouse)
- ✓Body weight and total serum IgE suitable for omalizumab dosing
- ✕Systemic prednisone (or equivalent) within 2 weeks prior to Visit 2
- ✕Systemic prednisone (or equivalent) for >30 of the 60 days prior to study entry
- ✕Pregnancy or breastfeeding
- ✕Acute sinusitis or chest infection requiring antibiotics within 1 month of screening
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Inner-City Anti-IgE Therapy for Asthma (ICAC-08)
In Brief
A Phase 4 clinical trial evaluating omalizumab and omalizumab placebo for Asthma. Completed, enrolled 419 participants across 8 sites.
Detailed Summary
The purpose of this study is to find out if adding omalizumab to standard asthma treatment results in a safer, more effective, and longer lasting asthma treatment strategy than standard treatment alone, in inner-city children with mild to severe asthma.
Study Details
Timeline
Interventions
Subcutaneous injections of omalizumab will be administered every 2 or 4 weeks along with standard of care for asthma for 60 weeks, beginning with the Randomization Visit. Dosage is dependent on participant's individual characteristics.
Subcutaneous injections of placebo will be administered every 2 or 4 weeks along with standard of care for asthma for 60 weeks, beginning with the Randomization Visit. Dosage is dependent on participant's individual characteristics.