Severe IgE-mediated Asthma Clinical Trial
Official title:
Multicentric, Open-label, Randomized, Parallel--group Study to Evaluate the Efficacy and Safety of Omalizumab in a 12- Month Period, in Patients With Severe IgE-mediated Asthma Inadequately Controlled With High Doses of Corticosteroids.
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.
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).
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