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Efficacy and Safety of Omalizumab in Children (6 - <12 Years) With Moderate-Severe, Inadequately Controlled Allergic Asthma

2014-08-27 03:54:31 | BioPortfolio

Summary

A substance called immunoglobulin E (IgE), which is naturally produced by our body, has a key role in generating asthma attacks. In patients with allergies, there is an exaggerated production of IgE in response to specific substances such as pollens. Omalizumab is a new drug that inactivates IgE. This study will test the safety and efficacy of omalizumab against asthma attacks in children with allergic asthma.

Description

This study is designed to provide one year efficacy and safety data for subcutaneous (SQ) omalizumab, compared to placebo in children (6 to < 12 years) with moderate to severe persistent asthma who have inadequate asthma control despite treatment according to NHLBI step 3 or 4 (at least medium dose inhaled corticosteroids with or without other controller asthma medications).

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Asthma

Intervention

Omalizumab, placebo

Location

Alabama Allergy and Asthma Center
Birmingham
Alabama
United States
35209

Status

Completed

Source

Novartis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:54:31-0400

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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.

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

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An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.

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).

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