NCT00314574

A Study of Omalizumab (Xolair) in Subjects With Moderate to Severe Persistent Asthma (EXTRA)

A Phase IIIb Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Xolair in Subjects With Moderate to Severe Persistent Asthma Who Are Inadequately Controlled With High-Dose Inhaled Corticosteroids and Long-Acting Beta-Agonists

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 850 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, double-blind, placebo-controlled study of the efficacy, safety, and tolerability of subcutaneously administered Xolair as add-on therapy for the treatment of subjects aged 12-75 years old diagnosed with moderate to severe asthma who are inadequately controlled with high-dose inhaled corticosteroids (ICS)+ long-acting beta-agonists (LABA) with or without additional controller therapy.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	omalizumab (Xolair)	Omalizumab (Xolair) was administered by subcutaneous (SC) injection every 2 or 4 weeks. Xolair was supplied as a sterile, white, preservative-free, lyophilized powder in single-use vials that were reconstituted with Sterile Water for Injection (SWFI), USP.
DRUG	placebo	Placebo was administered by subcutaneous (SC) injection every 2 or 4 weeks. Placebo contained the same ingredients as the lyophilized formulation of Xolair,excluding omalizumab.
DRUG	corticosteroids	Minimum dose of 500 µg of fluticasone dry-powder inhaler or its equivalent ex-valve dose twice a day.
DRUG	long-acting beta-agonists	50 µg salmeterol twice daily or 12 µg formoterol twice daily.

Timeline

• Start date: 2005-12-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2006-04-14
• Last updated: 2012-02-09
• Results posted: 2011-10-13