Conditions: Asthma
Keywords: Asthma, anti-immunoglobulin E, omalizumab, IgE receptors
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 31
Healthy volunteers: no

Brief summary:
The aim of this study is to evaluate the expression of IgE high affinity receptors (the part of the cell associated with allergic response) in patients suffering from uncontrolled severe asthma despite long term treatment with high dose of inhaled corticosteroid and long acting Beta-2 agonist.

Detailed description:
Double blind placebo controlled study to assess the expression of IgE on blood basophils and dendritic cells in patients with uncontrolled, severe, persistent allergic asthma after a 16-week Omalizumab treatment.

Arms:
arm 1: Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level. arm 2: Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.

Interventions: intervention 1: Omalizumab intervention 2: placebo
Intervention descriptions: intervention 1: Omalizumab was supplied as a sterile, freeze dried preparation, to be reconstituted to deliver 150mg of omalizumab. Each vial was reconstituted with 1.4ml of sterile water for injection. The appropriate dose and dosing frequency of omalizumab were determined by baseline total IgE and body weight. A dosing table was used following the European Summary of Product Characteristics (SmPC) of omalizumab. intervention 2: Placebo was a physiological salt solution, administered according to the same administration scheme to respect the same dosing frequency and injected volume.

Protocol document: