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

Allergic Asthma Clinical Trial

Official title: A Phase IV, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Persistency of Response With or Without Xolair After Long-term Therapy (XPORT)

Status Completed

Clinical Trial 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.

Clinical Trial Description

The treatment designation for participants who reached the primary efficacy endpoint (1 protocol-defined severe asthma exacerbation) was unblinded to allow appropriate clinical intervention. Participants who had their treatment designation unblinded remained in the study for ongoing evaluation of safety and were allowed to continue on study drug known to be Xolair (or to start study drug known to be Xolair if they were in the placebo group). ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Asthma

• NCT number: NCT01125748
• Study type: Interventional
• Source: Genentech, Inc.
• Status: Completed
• Phase: Phase 4
• Start date: May 2010
• Completion date: August 2013