At a glance
ClinicalIndex Comparison Record- ✓Age 6 to <12 years with body weight 20-150 kg
- ✓Diagnosis of allergic asthma ≥1 year duration per ATS criteria with moderate or severe persistent asthma per NHLBI guidelines
- ✓Total serum IgE 30-1300 IU
- ✓Positive prick skin test to at least one perennial allergen (documented within past 2 years or at Screening)
- ✕Recent systemic corticosteroids for non-asthma reasons, beta-blockers, anticholinergics within 24 hours, methotrexate, gold salts, cyclosporin, or troleandomycin
- ✕History of severe anaphylaxis to food/drugs, antibiotic allergy, or NSAID-induced asthma (unless NSAID avoidable)
- ✕Active lung disease, acute sinusitis/chest infection, or elevated serum IgE for other reasons
- ✕Uncontrolled systemic disease, history of cancer, abnormal ECG in previous month, or platelets ≤100 x10⁹/L or clinically significant laboratory abnormalities
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 1 Year, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Evaluation of Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Omalizumab in Children (6 - < 12 Years) With Moderate-severe, Persistent, Inadequately Controlled Allergic Asthma
In Brief
A Phase 3 clinical trial evaluating Omalizumab, Placebo, and 1 other intervention for Asthma. Completed, enrolled 628 participants across 56 sites.
Detailed Summary
A substance called immunoglobulin E (IgE), which is naturally produced by our body, has a key role in generating asthma attacks. In patients with allergies, there is an exaggerated production of IgE in response to specific substances such as pollens. Omalizumab is a new drug that inactivates IgE. This study tested the safety and efficacy of omalizumab against asthma attacks in children with allergic asthma.
Study Details
Timeline
Interventions
The omalizumab dose administered, based on the patient's body weight and total serum IgE level at Screening, and the number of injections and injection volume was determined from the dosing tables in the protocol. Omalizumab 75 to 375 mg was administered subcutaneous (SC) every 2 or 4 weeks depending on the dose.
Placebo was administered subcutaneous (SC) every 2 or 4 weeks depending on the dosing schedule in the protocol.
Patients entered the study using their current formulation of any inhaled steroid (proprietary drug and device) ≥ 200 μg/day equivalent of fluticasone administered with a dry-powder inhaler.