Non-invasive Measures of Effects of Xolair in Asthma

Asthma Clinical Trial

Official title: Non-Invasive Measures of Distal Lung Disease in Asthmatics Before and After Treatment With Omalizumab

Status Terminated

Clinical Trial 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.

Clinical Trial Description

This is a prospective pilot study evaluating the effect of omalizumab on the small airways of moderate to severe asthmatic individuals who are not fully controlled on fluticasone/salmeterol 250/50 or 500/50 mcg 1 puff bid. After screening, all subjects will be placed on fluticasone/salmeterol 250/50 or 500/50 mcg 1 puff bid for a 6-week run-in. Subjects will then be evaluated for level of asthma control. Individuals with total control of their asthma (no daytime or nighttime symptoms, no rescue use of short-acting inhaled beta-agonist, normal PEF, no unscheduled office visits, no ER visits) will be excluded from the study. Subjects without total asthma control will then have baseline studies performed to include HRCT of the chest before and after a methacholine challenge test (MCT), spirometry, closing volume, inspiratory capacity, symptom scores, asthma questionnaires, exhaled NO (performed at different expiratory flow rates to estimate alveolar NO) and blood work for evaluation of eosinophils and ECP, and banked serum. Subjects who meet acceptable criteria for omalizumab dosing based on serum IgE levels and body weight and the presence of atopy (at least one positive skin test to a common environmental allergen) will then receive omalizumab in addition to fluticasone/salmeterol 250/50 or 500/50 mcg 1 puff bid for sixteen weeks. Subjects will be seen every 2-4 weeks during the sixteen-week treatment phase to receive injections as prescribed and every 4 weeks to measure spirometry, inspiratory capacity, and to evaluate the level of compliance. After the sixteen-week treatment phase subjects will again undergo HRCT of the chest before and after a MCT [in the case where the follow-up methacholine responsiveness is diminished (improved) a mid-scan will be performed at the prior (target) methacholine dose and the challenge then continued to a maximum dose of 16 mg/ml and a third scan done], spirometry, closing volume, inspiratory capacity, exhaled NO at different expiratory flow rates (to estimate alveolar NO) and blood work for evaluation of eosinophils and ECP and banked serum. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

• NCT number: NCT00784485
• Study type: Interventional
• Source: University of California, Los Angeles
• Status: Terminated
• Phase: Phase 4
• Start date: February 2009
• Completion date: February 2011