At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase IV, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Persistency of Response With or Without Xolair After Long-term Therapy (XPORT)
In Brief
A Phase 4 clinical trial evaluating Omalizumab, Placebo, and 1 other intervention for Allergic Asthma. Completed, enrolled 176 participants across 100 sites.
Detailed 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.
Study Details
Timeline
Interventions
Omalizumab was supplied as a sterile, white, preservative-free, lyophilized powder in single-use vials that was reconstituted with sterile water for injection.
Placebo contained the same ingredients as the omalizumab formulation, excluding omalizumab.
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.