NCT01125748

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

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 176 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 17 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Allergic Asthma

Interventions

Type	Name	Description
DRUG	Omalizumab	Omalizumab was supplied as a sterile, white, preservative-free, lyophilized powder in single-use vials that was reconstituted with sterile water for injection.
DRUG	Placebo	Placebo contained the same ingredients as the omalizumab formulation, excluding omalizumab.
DRUG	Asthma therapies	Participants could receive 1 or more of the following medications as concomitant asthma therapy: Inhaled corticosteroids; long acting beta-agonists; zafirlukast or other leukotriene receptor antagonist; zileuton or other 5-lipoxygenase enzyme inhibitors; oral, inhaled, and/or nasal anticholinergic therapy; mast-cell stabilizers; theophyllines; chronic oral corticosteroids, defined as a minimum dose of oral prednisone of 2 to 40 mg/day or 5 to 80 mg every other day.

Timeline

• Start date: 2010-05-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2010-05-18
• Last updated: 2014-10-15
• Results posted: 2014-10-15

Locations

100 sites across 1 country: United States