drugset / Trial / NCT04607629

An Efficacy and Safety Study of Genolar® and Xolar® in the Persistent Atopic Bronchial Asthma

NCT04607629

Phase 3 Completed 192 enrolled AO GENERIUM
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a randomized, double-blind, comparative, parallel-group study of the efficacy and safety of Genolar® and Xolair® in the treatment of persistent atopic bronchial asthma of moderate and severe course, whose symptoms are insufficiently controlled by the 4-step treatment GINA (2017)

Timeline

Start
2018-06-20
Primary completion
2019-04-29
Completion
2019-12-13

Drugs

EvaluationDrugModalityDoseRoute
Subject Omalizumab Monoclonal antibody 75 mg Subcutaneous
Subject Omalizumab Monoclonal antibody 600 mg Subcutaneous
Background Symbicort Unknown 9 ug Inhaled
Background Symbicort Unknown 320 ug Inhaled

Indications