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

NCT00851370 | Withdrawn Phase 2 DMC

• 1 other identifier: NJ-241
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

COPD; Exacerbation

Outcome Measures

Primary Outcomes (1)

• COPD Exacerbations

  48 weeks

Study Arms (2)

Omalizumab

EXPERIMENTAL

Drug: Omalizumab (Xolair)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Omalizumab (Xolair) DRUG

Bi-weekly

Also known as: Xolair

Omalizumab

Placebo DRUG

Bi-Weekly

Placebo

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Jewish Health: lead
• Novartis: collaborator

Study Sites (1)

National Jewish Health

Denver, Colorado, 80206, United States

Location

Related Publications (3)

• 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.

  PMID: 15249466 BACKGROUND

• 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.

  PMID: 15794718 BACKGROUND

• 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.

  PMID: 16608932 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Officials

• Russell P Bowler, MD, PhD

  National Jewish Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2009
• First Posted: February 25, 2009
• Study Start: January 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: March 29, 2017

Record last verified: 2017-03

Locations

US (1)