NCT00851370

Exploratory Study of Xolair in Chronic Obstructive Pulmonary Disease in Patients With Elevated IgE Levels

Exploratory Study of Xolair (Omalizumab)to Improve Outcomes in Patients With COPD and Elevated IgE Levels, and Positive RAST or Skin Prick Tests

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: National Jewish Health · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The objective is to conduct an exploratory study on the effect of Omalizumab on COPD patients with elevated IgE. Exploratory outcomes include to determine whether Omalizumab use: reduces exacerbations in COPD patients; or improves rescue medication use, decreases ICS use, modified Medical Research Council (MMRC) dyspnea score, St. George's Respiratory Questionnaire (SGRQ), 6-minute walk distance (6MWD), forced expiratory volume at one second (FEV1)(the latter 3 with BMI make up the BODE score), residual volume (RV), total lung capacity (TLC), exhaled nitric oxide (ENO), and determination C-reactive protein (CRP).

Conditions

• Pulmonary Disease, Chronic Obstructive

Interventions

Type	Name	Description
DRUG	Omalizumab (Xolair)	Bi-weekly
DRUG	Placebo	Bi-Weekly

Timeline

• Start date: 2009-01-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2009-02-25
• Last updated: 2017-03-29

Locations

1 site across 1 country: United States