850
Participants
Start Date
December 31, 2005
Primary Completion Date
November 30, 2009
Study Completion Date
November 30, 2009
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.
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.
corticosteroids
Minimum dose of 500 µg of fluticasone dry-powder inhaler or its equivalent ex-valve dose twice a day.
long-acting beta-agonists
50 µg salmeterol twice daily or 12 µg formoterol twice daily.
Lead Sponsor
Genentech, Inc.
INDUSTRY