drugset / Trial / NCT01912872
Study to Assess the Efficacy and Safety of Omalizumab Treatment on ICS Reduction for Severe IgE-mediated Asthma
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2013-11-11
- Primary completion
- 2015-08-06
- Completion
- 2016-01-08
Outcome
Outcome not reported
Stopped: “Termination was due to identified errors in data management handling after an internal audit by the sponsor performed by third party.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Omalizumab | Monoclonal antibody | — | Subcutaneous |
| Background | Budesonide | Small molecule | 100 ug | Oral |
| Background | Budesonide | Small molecule | 200 ug | Oral |
| Background | Budesonide | Small molecule | 400 ug | Oral |
| Comparator | Formoterol | Other / unclassified | 12 ug | Oral |