drugset / Trial / NCT00096954

A Prospective, Randomized, Double-Blind Study of the Efficacy of Omalizumab (Xolair) in Atopic Asthmatics With Good Lung Capacity Who Remain Difficult to Treat (EXACT)

NCT00096954

Phase 4 Completed 333 enrolled Genentech, Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

This was a multicenter, parallel-group, double-blind, randomized, placebo-controlled study that enrolled 333 subjects. These subjects were 12-75 years old with atopic asthma, had elevated serum total Immunoglobulin E (IgE), had a baseline forced expiratory volume in 1 second (FEV1) ≥ 80% predicted, and were on inhaled corticosteroids with or without other controller asthma medications (e.g., long-acting β2-agonists \[LABAs\], leukotriene receptor antagonist \[LTRA\], or immunotherapy).

Timeline

Start
2006-02
Primary completion
2010-09
Completion
2010-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Omalizumab Monoclonal antibody Subcutaneous

Indications