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

Part of paid clinical trials in Denver, Colorado.

Sponsor
National Jewish Health
Study ID
NCT00851370
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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).

Key Dates

First listed
Feb 25, 2009
Start date
Jan 31, 2009
Status verified
Mar 2017
Primary completion
Feb 28, 2011
Completion
Feb 28, 2011

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Omalizumab
  • Placebo Comparator: Placebo

Primary Outcome Measure

COPD Exacerbations [ Time Frame: 48 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
National Jewish HealthDenverColorado80206-

Find similar trials in Denver, CO

Nationwide
COPD trialsPulmonology trialsLung disease trials
By condition
COPD
By specialty
PulmonologyLung disease
By research site
National Jewish Health· Denver, CO

Related Studies