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

This study has been withdrawn prior to enrollment.
(Unable to find eligible subjects- study closed)
Sponsor:
Collaborator:
Novartis
Information provided by:
National Jewish Health
ClinicalTrials.gov Identifier:
NCT00851370
First received: February 4, 2009
Last updated: July 19, 2011
Last verified: April 2011
  Purpose

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).


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: Omalizumab (Xolair)
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Exploratory Study of Xolair (Omalizumab)to Improve Outcomes in Patients With COPD and Elevated IgE Levels, and Positive RAST or Skin Prick Tests

Resource links provided by NLM:


Further study details as provided by National Jewish Health:

Primary Outcome Measures:
  • COPD Exacerbations [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2009
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Omalizumab Drug: Omalizumab (Xolair)
Bi-weekly
Other Name: Xolair
Placebo Comparator: Placebo Drug: Placebo
Bi-Weekly

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Smoking-related COPD and aged between 40 and 70 yrs.
  • Total IgE of 30-700 IU and a positive RAST or skin prick test result to one or more perennial environmental allergens (e.g. dust mite (Dermatophagoides farinae, Dermatophagoides pteronyssinus), cockroach, dog, or cat.)
  • Any race or sex; women with childbearing potential are required to use an acceptable method for birth control and have a negative pregnancy test
  • History of ≥2 exacerbations during 2 yrs previous to the enrollment date
  • An exacerbation will be defined as an increase or new onset of more than one of the following: cough, sputum, wheezing, dyspnea, or chest tightness with a duration of at least 3 days requiring antibiotic or systemic steroid treatment. The severity of an exacerbation will be determined by the following:
  • Mild: Home management, with or without contacting a health care provider, or unscheduled office visit
  • Moderate: Requiring a visit to an emergency department
  • Severe: Requiring hospitalization
  • Very Severe: Requiring intubation and medical ventilation
  • Post-bronchodilator FEV1 30-64% of predicted; the first 5 subjects enrolled will be required to have post-bronchodilator FEV1 50-64%
  • Post-bronchodilator FEV1/FVC < 0.7
  • Smokers or ex-smokers with at least a 20 pack-year smoking history
  • Able to communicate meaningfully with the study personnel and to understand and read fluently in English
  • Written informed consent;
  • BODE score 3-10.

Exclusion Criteria:

  • History of Omalizumab use
  • Evidence of illicit drug use or abuse of alcohol.
  • Women of childbearing potential not using the contraception method(s) specified in this study (specify), as well as women who are breastfeeding
  • Known sensitivity to study drug(s) or class of study drug(s)
  • Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (specify as required)
  • Use of any other investigational agent in the last 30 days
  • Continuous treatment with oral corticosteroids
  • Participating in another trial within 3 months prior to the beginning of the study
  • Non-compliance in taking medications
  • Planned for lung transplantation at the time of admission to the study or expected to be transplanted within 3 yrs
  • Alpha-1-antitrypsin deficiency
  • Cystic fibrosis
  • Bronchiectasis
  • History of infection or active infection due to Mycobacterium tuberculosis
  • Pneumoconiosis
  • Pulmonary restriction due to any other pulmonary disease, apart from the one concerned with the study population
  • Congestive heart failure class 2 or more of the New York Heart Association (NYHA)
  • Reduced life expectancy due to other disease (defined as having an expected mortality of ≥25% five years from enrollment)
  • Current use of ß-blockers
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00851370

Locations
United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80206
Sponsors and Collaborators
National Jewish Health
Novartis
Investigators
Principal Investigator: Russell P Bowler, MD, PhD National Jewish Health
  More Information

Publications:
Responsible Party: Russell Bowler MD, PhD, National Jewish Health
ClinicalTrials.gov Identifier: NCT00851370     History of Changes
Other Study ID Numbers: NJ-241
Study First Received: February 4, 2009
Last Updated: July 19, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by National Jewish Health:
COPD
Exacerbation

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Omalizumab
Anti-Allergic Agents
Anti-Asthmatic Agents
Pharmacologic Actions
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014