drugset / Trial / NCT01125748

A Study Evaluating the Persistency of Response With or Without Xolair (Omalizumab) After Long-term Therapy

NCT01125748

Phase 4 Completed 176 enrolled Genentech, Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

This was a randomized, double-blind, placebo-controlled, 2-arm, 1-year study of participants who completed the EXCELS study (NCT00252135) and had received long-term treatment with Xolair. In addition, participants who did not participate in the EXCELS study but received long-term (\~5 years) treatment with Xolair were allowed to enter the study.

Timeline

Start
2010-05
Primary completion
2013-08
Completion
2013-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Omalizumab Monoclonal antibody Subcutaneous
Background Prednisone Other / unclassified Oral
Background Zafirlukast Small molecule
Background Zileuton Small molecule

Indications