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A Study to Evaluate the Efficacy of Xolair in Atopic Asthmatics

2014-08-27 03:53:52 | BioPortfolio

Summary

This is a multicenter, parallel-group, double-blind, randomized, placebo-controlled study that will enroll approximately 300 subjects. These subjects will be 12-75 years old with atopic asthma, have a history of asthma exacerbations, have elevated serum total IgE, have a baseline FEV1 ≥ 80% predicted, and be on inhaled corticosteroids with or without other controller asthma medications (e.g., long-acting β2-agonists [LABAs], leukotriene receptor antagonist [LTRA], or immunotherapy).

Study Design

Allocation: Randomized, Control: Placebo Control, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Asthma

Intervention

omalizumab, placebo

Status

Active, not recruiting

Source

Genentech

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:53:52-0400

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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.

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

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

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.

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