drugset / Trial / NCT00784485

Non-invasive Measures of Effects of Xolair in Asthma

NCT00784485

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to look at the effectiveness of Xolair® (omalizumab) in people with asthma taking Advair Diskus®. The study will look at the effects of Xolair® on lung function using high resolution computed tomography (HRCT) scans after asthma symptoms are induced with a special substance called methacholine. This study is only taking place at UCLA, where about 13 subjects will be enrolled. Participation requires 10-14 visits over about 26 weeks. Subjects will receive an albuterol inhaler to use as needed for immediate relief of symptoms and fluticasone 250 mcg/salmeterol 50 mcg or fluticasone 500 mcg/salmeterol 50 mcg (Advair Diskus® 250/50 or 500/50) to be taken twice daily. At certain visits, they will be given Xolair® injections followed by various assessments, including CT scans and lung function tests.

Timeline

Start
2009-02
Primary completion
2011-02
Completion
2011-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Omalizumab Monoclonal antibody 150 mg Subcutaneous
Subject Omalizumab Monoclonal antibody 375 mg Subcutaneous

Indications