Non-invasive Measures of Effects of Xolair in Asthma
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Non-Invasive Measures of Distal Lung Disease in Asthmatics Before and After Treatment With Omalizumab|
- Change in methacholine shift at baseline compared with the shift after treatment phase. 6 (out of a possible 18) anatomic segment dorsal-peripheral zones demonstrating the greatest decrease in attenuation with methacholine will be selected for analysis. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Baseline to post-treatment change in pre-methacholine lung attenuation, using the baseline lung attenuation curve as a covariate. Done for all anatomic segment dorsal-peripheral zones. Results averaged for each subject and averages mean across subjects [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Physiologic markers (isovolume FEF25-75%, closing volume, the alveolar portion of FENO, and serum markers of inflammation) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Ordinal data from questionnaires and diaries [ Time Frame: 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||February 2009|
|Study Completion Date:||February 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
Experimental: Xolair injections
All subjects receive active drug (Xolair-see 'interventions').
Drug: Xolair injections
In addition to Advair Diskus 250/50 or 500/50, subjects will receive 150 to 375 mg subcutaneous injection every 2 or 4 weeks (depending on IgE levels) for 16 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00784485
|United States, California|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Eric C Kleerup, MD||University of California, Los Angeles|