Conditions: Severe IgE-mediated Asthma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 112
Healthy volunteers: no

Brief summary:
Assess efficacy and safety of omalizumab treatment during 12 months in order to reduce the use of inhaled corticosteroid (ICS) in pediatric and adult participants with severe Immunoglobulin E (IgE)-mediated asthma inadequately controlled with high doses of corticosteroids.

Detailed description:
This was a multicentric, open label, randomized, parallel-group study with a 12-month treatment period. Participants were assigned to one of the 2 treatment groups, omalizumab plus budesonide/formoterol or budesonide/formoterol alone.

The study comprised 4 phases:

During the 4-week run-in phase adult participants received budesonide 800 mg and formoterol 24 mg. If a participant complied with all inclusion and exclusion criteria and had received the according-to-age run-in proposed doses during the last month, the participant continued to the stable-steroid phase.

During the 16-week stable-steroid phase, adult and pediatric eligible participants were randomized to one of the two treatment groups.

During the 8-week steroid-reduction phase, adult and pediatric participants reduced 25% of the budesonide baseline dose every 2 weeks, depending of the asthma control, until they reached a 100% reduction of the baseline dose. The clinical control of asthma was defined according to criteria (GINA 2012).

Arms:
arm 1: Participants will receive Omalizumab every 2 or 4 weeks depending on IgE level and body weight and will also receive budesonide and formoterol according to maximum daily dose. arm 2: Participants will receive budesonide and formoterol according to maximum daily dose.

Interventions: intervention 1: Omalizumab intervention 2: Budesonide intervention 3: Formoterol intervention 4: Budesonide intervention 5: Formoterol
Intervention descriptions: intervention 1: Subcutaneous injection dose according to the IgE level and body weight. intervention 2: Budesonide (400 μg, 200 μg or 100 μg) tablets taken orally according to maximum daily dose. intervention 3: Formoterol 12ug tablets taken orally according to maximum daily dose. intervention 4: Budesonide (400 μg, 200 μg or 100 μg). Patients were instructed to take the inhaled budesonide doses every 12 hours following the specific administration instructions as per the manufactures' prescription information. intervention 5: Formoterol 12ug. Patients were instructed to take the inhaled formoterol doses every 12 hours following the specific administration instructions as per the manufactures' prescription information.

Protocol document: