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Xolair (Omalizumab) - Summary

 
 



XOLAIR SUMMARY

Xolair (Omalizumab) is a recombinant DNA-derived humanized IgG1(kappa) monoclonal antibody that selectively binds to human immunoglobulin E (IgE).

Xolair (Omalizumab) is indicated for adults and adolescents (12 years of age and above) with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids. Xolair has been shown to decrease the incidence of asthma exacerbations in these patients. Safety and efficacy have not been established in other allergic conditions.


See all Xolair indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Xolair (Omalizumab)

Xolair® improves rate of severe asthma exacerbations
Source: Doctors Lounge - Chest Diseases
Xolair reduced the rate of hospital emergency visits by 44% in patients with inadequately controlled asthma.

VR475 shown significant benefit in a Phase IIb/III trial for severe asthma
Source: Respiratory / Asthma News From Medical News Today [2014.12.12]
Vectura Group plc has announced the publication in the European Respiratory Journal (ERJ) of a clinical study demonstrating positive results from its Phase IIb/III (Acti-AICS-001) clinical trial...

Asthma
Source: MedicineNet Allergy Specialty [2014.12.12]
Title: Asthma
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 12/12/2014 12:00:00 AM

Bed-sharing toddlers 'more likely to develop asthma in later childhood'
Source: Respiratory / Asthma News From Medical News Today [2014.12.11]
Examining an association between toddlers who share the bed with their parents and risk of asthma later in childhood, researchers suggest that the link is multifactorial.

Raised Asthma Risk Seen for Toddlers Who Share Bed With Parents
Source: MedicineNet Sleep Specialty [2014.12.11]
Title: Raised Asthma Risk Seen for Toddlers Who Share Bed With Parents
Category: Health News
Created: 12/11/2014 12:00:00 AM
Last Editorial Review: 12/11/2014 12:00:00 AM

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Published Studies Related to Xolair (Omalizumab)

Immunologic effects of omalizumab in children with severe refractory atopic dermatitis: a randomized, placebo-controlled clinical trial. [2013]
mediated by the TSLP pathway in young patients with severe refractory AD... CONCLUSIONS: Anti-IgE therapy with omalizumab decreases levels of cytokines that

Population-based efficacy modeling of omalizumab in patients with severe allergic asthma inadequately controlled with standard therapy. [2013]
Omalizumab, a recombinant humanized monoclonal antibody, is the first approved anti-immunoglobulin E (IgE) agent for the treatment of subjects with moderate to severe persistent allergic asthma that are inadequately controlled by the standard of care... In addition, the resulting population models could be used to predict population FEV1 or FeNO response for omalizumab and/or other anti-IgE therapeutics for which PK-IgE models are constructed.

Omalizumab is effective in allergic and nonallergic patients with nasal polyps and asthma. [2013]
omalizumab in patients with nasal polyps and comorbid asthma... CONCLUSION: Omalizumab demonstrated clinical efficacy in the treatment of nasal

Omalizumab and the risk of malignancy: results from a pooled analysis. [2012]
pooled data from clinical trials of omalizumab-treated patients... CONCLUSIONS: In this pooled analysis no association was observed between

A randomized, placebo-controlled, dose-ranging study of single-dose omalizumab in patients with H1-antihistamine-refractory chronic idiopathic urticaria. [2011.09]
BACKGROUND: Proof-of-concept studies with omalizumab in patients with chronic idiopathic urticaria (CIU) have shown significant decreases in mean urticaria activity scores (UASs). OBJECTIVE: We sought to evaluate the efficacy and safety of omalizumab in patients with CIU who remain symptomatic despite concomitant H(1)-antihistamine therapy... CONCLUSION: This study demonstrated that a fixed dose of 300 or 600 mg of omalizumab provides rapid and effective treatment of CIU in patients who are symptomatic despite treatment with H(1)-antihistamines. Copyright (c) 2011 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved.

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Clinical Trials Related to Xolair (Omalizumab)

Study to Evaluate the Effect of Xolair(Omalizumab) on Improving the Tolerability of Specific Immunotherapy in Patients With at Least Moderate Persistent Allergic Asthma Inadequately Controlled With Inhaled Corticosteroids [Completed]
In patients with at least moderate persistent allergic asthma controlled with inhaled steroids, omalizumab (administered per US product label), when compared to placebo, will provide the participants with significantly improved tolerability of specific allergen immunotherapy (allergy shots) administered per a cluster schedule(rapid build up method).

The Effect of Xolair (Omalizumab) on Allergy Blood Cells [Recruiting]
We are studying Xolair (omalizumab) to see it's effect on allergic blood cells. The blood tests will be done in a test tube to see if they react differently before and after treatment. The blood cells will be mixed with to whatever the person is allergic.

Effect of Xolair on Airway Hyperresponsiveness [Recruiting]
The purpose of this study is to determine if Xolair can reduce the abnormal increase in limitation to airflow in patients with asthma in a relatively short time period. Another purpose is to determine if Xolair will decrease the amount of inflammation in the lungs of an asthmatic patient in the same time period.

Effect of Ozone on Airway Inflammation in Allergic Asthmatics Treated With Omalizumab [Terminated]
Ozone can cause acute airway inflammation in both asthmatics and normal volunteers. However, in asthmatics ozone can cause episodes of worsening of asthma. We want to learn if chronic allergic response, known as "IgE-induced airway inflammation" is what causes the increased inflammation in response to ozone. To do this we will examine the response to ozone in a group of asthmatics treated with omalizumab, a medicine available and approved for use in people with asthma, or a placebo control. The placebo for this study is inert physiologic saline ("salt water") which contains no omalizumab. Both the omalizumab and the placebo will be administered as an injection under the skin. Omalizumab, also called Xolair, is a humanized monoclonal antibody, which means that it originally was produced in mice, then genetically engineered to look more like human than mouse antibody. Omalizumab inactivates IgE, a protein our own immune systems make as part of allergic reactions. The purpose of this study is to test the hypothesis that omalizumab, by blocking this aspect of allergic reactions, will decrease the number of inflammatory cells in the airway after ozone challenge. We also hypothesize that omalizumab will decrease the effects of ozone on changes in lung function, mucociliary clearance (a measure of how quickly mucus clears form the airway) and airway reactivity. Airway reactivity is a measure of how sensitive the airways are to a medication used to diagnose asthma, called methacholine. We will examine these as additional information we can learn during the course of the study. This is a blinded study, meaning that neither you nor the researchers know if you get the active drug or placebo, but that information can be obtained if needed. The placebo is an injection of inert physiological saline ("salt water") which contains no omalizumab.

Non-invasive Ways to Evaluate Lung Disease After Treatment With Xolair [Recruiting]
The purpose of this study is to study the effects of Xolair using non-invasive techniques from the expired gas of patients with moderate to severe allergic asthma.

more trials >>

Reports of Suspected Xolair (Omalizumab) Side Effects

Asthma (543)Dyspnoea (439)Cough (369)Nasopharyngitis (333)Fatigue (306)Wheezing (250)Malaise (230)Pneumonia (186)Blood Pressure Increased (178)Headache (169)more >>


Page last updated: 2014-12-12

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