Advertisement

Topics

Effects of Omalizumab Compared to Non-Omalizumab Treatment in Asthma Patients

2016-10-03 23:38:21 | BioPortfolio

Summary

The purpose of this study is effects of Omalizumab compared to non-Omalizumab treatment in the propensity-matched group on asthma exacerbation in asthma patients in Korea: a retrospective cohort in real world.

Omalizumab was approved 2007 in Korea and has been used in this center. We would like to collect and analyze the data and exacerbation outcomes of these patients on Omalizumab; no Korean real world data available.

Description

1. Primary and secondary outcomes and analysis methods

(1) Primary endpoint Comparison of asthma exacerbation rates of omalizumab-treated vs non-Omalizumab treated group at outcome period (6 months). (asthma exacerbation: at least 1 systemic steroid treatment and/or bursts of systemic oral steroid use by prednisone-equivalent dose ≥45mg/3days, in a 6 month for relieving asthma exacerbations.) Fisher's exact test is examined for asthma exacerbation between omalizumab-treated vs non-Omalizumab treated group.

(2) Secondary endpoint

- Comparison of the clinical parameters Asthma exacerbation rate, ICS sparing effect, OCS requirement, lung function (FEV1%), Healthcare resource use (asthma-related ER visit/hospitalization)

1. Within Omalizumab-treated group between baseline and outcome period

2. Between Omalizumab-treated and not-treated groups at outcome period For comparison of within group, paired T-test and McNemar test are applied for continuous and categorical parameters, respectively. And, T-test and Fisher's exact test are examined for continuous and categorical parameters between Omalizumab-treated and not-treated groups. Incidentally, non-parametric tests will be examined as needed.

- Finding predictor of favorable responders to Omalizumab at 6 months. (Favorable responder: 50% reduction of asthma exacerbation or of steroid requirement during 6 months with/without ICS/LABA) Candidate factors: Omalizumab treatment period/monthly dose, age, gender, asthma treatment duration, total IgE, sputum cell profile, peripheral eosinophilia serum periostin level, anti-asthmatic drug requirements etc.

Binary logistic regression is used for finding predictor of favorable responders. If a serious imbalance of dependent parameter occurs from a low frequency of favorable responder, the descriptive analysis will be applied with T-test and Fisher's exact test.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Conditions

Asthma

Intervention

Omalizumab

Status

Active, not recruiting

Source

Ajou University School of Medicine

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-10-03T23:38:21-0400

Clinical Trials [1305 Associated Clinical Trials listed on BioPortfolio]

Efficacy and Safety of Omalizumab in Patients With Severe Persistent Asthma

The purpose of this study is to determine the effect of omalizumab, compared to placebo, on clinically significant asthma exacerbation rates in adolescents and adults with asthma.

Omalizumab in Adult and Adolescent Patients With Severe Persistent Allergic Asthma

Omalizumab will be given as add-on treatment to optimized asthma therapy in patients with severe persistent asthma, who demonstrate inadequate asthma symptom control. Response to omalizuma...

Safety and Tolerability of Omalizumab in Patients With Mild to Moderate Asthma

This study will evaluate the safety and efficacy of omalizumab against asthma attacks in mild to moderate allergic asthma

Safety and Tolerability of Omalizumab in Adults and Adolescents With Severe Allergic Asthma

This study will assess further the safety and tolerability of long-term treatment with omalizumab by extending omalizumab treatment by 1 year for those patients with allergic asthma who su...

Study to Evaluate the Effect of Omalizumab on Improving the Tolerability of Specific Immunotherapy in Patients With Persistent Allergic Asthma

This study is designed to investigate the use of omalizumab as a pretreatment for patients with persistent allergic asthma who are candidates for allergen immunotherapy (ie, allergy shots)...

PubMed Articles [1017 Associated PubMed Articles listed on BioPortfolio]

Duration of the efficacy of omalizumab after treatment discontinuation in 'real life' severe asthma.

Efficacy of omalizumab in severe asthma is well documented; however, the optimal duration of the treatment remains unclear. In an open prospective study, we sought to assess the persistence of respons...

Real-world health care utilization and effectiveness of omalizumab for the treatment of severe asthma.

Omalizumab is indicated for the treatment of moderate to severe asthma. There is limited observational evidence on the costs and effectiveness of omalizumab.

The Use of Omalizumab in Allergen Immunotherapy.

Although omalizumab (anti-IgE) is currently only approved for the treatment of asthma and chronic idiopathic urticaria, it has also been studied as an off-label treatment for numerous allergic conditi...

Long-term "real-life" safety of omalizumab in patients with severe uncontrolled asthma: A nine-year study.

Randomized Controlled Trials showed that omalizumab exhibited a good safety and tolerability profile in patients with moderate-to-severe asthma. However, safety data of long-term treatment with omaliz...

Pregnancy-associated plasma protein-A (PAPP-A) levels in patients with severe allergic asthma are reduced by omalizumab.

Remodeling is a crucial feature of severe asthma and may be associated with activation of the allergic cascade by immunoglobulin E (IgE). Omalizumab, an anti-IgE monoclonal antibody, effectively targe...

Medical and Biotech [MESH] Definitions

An anti-IgE, recombinant, humanized monoclonal antibody which specifically binds to the C epsilon3 domain of IMMUNOGLOBULIN E, the site of high-affinity IgE receptor binding. It inhibits the binding of IgE to MAST CELLS and BASOPHILS to reduce the severity of the allergic response and is used in the management of persistent allergic ASTHMA.

Asthma attacks caused, triggered, or exacerbated by OCCUPATIONAL EXPOSURE.

Asthma attacks following a period of exercise. Usually the induced attack is short-lived and regresses spontaneously. The magnitude of postexertional airway obstruction is strongly influenced by the environment in which exercise is performed (i.e. inhalation of cold air during physical exertion markedly augments the severity of the airway obstruction; conversely, warm humid air blunts or abolishes it).

Drugs that are used to treat asthma.

A beta-adrenergic agonist used in the treatment of asthma and bronchospasms.

More From BioPortfolio on "Effects of Omalizumab Compared to Non-Omalizumab Treatment in Asthma Patients"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Allergies
The term allergy is used to describe a response, within the body, to a substance, which is not necessarily harmful in itself, but results in an immune response and a reaction that causes symptoms and disease in a predisposed person, which in turn can cau...

Asthma
Asthma is caused by inflammation of small tubes, called bronchi, which carry air in and out of the lungs. If you have asthma, the bronchi will be inflamed and more sensitive than normal.  When you come into contact with something that irritates your...

Pulmonary
Pulmonary relating to or associated with the lungs eg Asthma, chronic bronchitis, emphysema, COPD, Cystic Fibrosis, Influenza,  Lung Cancer, Pneumonia, Pulmonary Arterial Hypertension, Sleep Disorders etc Follow and track Lung Cancer News ...


Searches Linking to this Trial