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

NCT ID: NCT00851370

Last Updated: 2017-03-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2011-02-28

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Omalizumab

Group Type: EXPERIMENTAL

Omalizumab (Xolair)

Intervention Type: DRUG

Bi-weekly

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Bi-Weekly

Interventions

Omalizumab (Xolair)

Bi-weekly

Intervention Type: DRUG

Placebo

Bi-Weekly

Intervention Type: DRUG

Other Intervention Names

Xolair

Eligibility 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

National Jewish Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Russell P Bowler, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Jewish Health

Locations

National Jewish Health

Denver, Colorado, United States

Countries

United States

References

Cazzola M, Dahl R. Inhaled combination therapy with long-acting beta 2-agonists and corticosteroids in stable COPD. Chest. 2004 Jul;126(1):220-37. doi: 10.1378/chest.126.1.220.

Reference Type: BACKGROUND

PMID: 15249466 (View on PubMed)

Bonay M, Bancal C, Crestani B. The risk/benefit of inhaled corticosteroids in chronic obstructive pulmonary disease. Expert Opin Drug Saf. 2005 Mar;4(2):251-71. doi: 10.1517/14740338.4.2.251.

Reference Type: BACKGROUND

PMID: 15794718 (View on PubMed)

Imfeld S, Bloch KE, Weder W, Russi EW. The BODE index after lung volume reduction surgery correlates with survival. Chest. 2006 Apr;129(4):873-8. doi: 10.1378/chest.129.4.873.

Reference Type: BACKGROUND

PMID: 16608932 (View on PubMed)

Other Identifiers

NJ-241

Identifier Type: -

Identifier Source: org_study_id