Non-invasive Measures of Effects of Xolair in Asthma
|ClinicalTrials.gov Identifier: NCT00784485|
Recruitment Status : Terminated (Terminated due to poor enrollment.)
First Posted : November 4, 2008
Last Update Posted : March 9, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: Xolair injections||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Non-Invasive Measures of Distal Lung Disease in Asthmatics Before and After Treatment With Omalizumab|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||February 2011|
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.
- 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 ]
- 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 ]
- Physiologic markers (isovolume FEF25-75%, closing volume, the alveolar portion of FENO, and serum markers of inflammation) [ Time Frame: 3 months ]
- Ordinal data from questionnaires and diaries [ Time Frame: 3 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00784485
|United States, California|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Eric C Kleerup, MD||University of California, Los Angeles|