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

Study Overview
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Brief Summary
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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).

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

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Drug: Omalizumab (Xolair)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omalizumab<br> | Drug: Omalizumab (Xolair)<br>* Bi-weekly<br>* Other names: Xolair;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Bi-Weekly<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COPD Exacerbations |  | 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Exacerbation