Effect of Omalizumab on Expression of IgE Receptors in Adults With Severe, Inadequately Controlled Allergic Asthma
Summary
The aim of this study is to evaluate the expression of IgE high affinity receptors (the part of the cell associated with allergic response) in patients suffering from uncontrolled severe asthma despite long term treatment with high dose of inhaled corticosteroid and long acting Beta-2 agonist.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Asthma
Intervention
Omalizumab, placebo
Location
Novartis Investigator site
Rueil-Malmaison
France
Status
Completed
Source
Novartis
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00454051
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Therapeutic Misconception
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
Placebo Effect
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, Exercise-induced
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).
Anti-asthmatic Agents
Drugs that are used to treat asthma.
Orciprenaline
A beta-adrenergic agonist used in the treatment of asthma and bronchospasms.
Clinical Trials
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Omalizumab in Adult and Adolescent Patients With Severe Persistent Allergic Asthma
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PubMed Articles
ABSTRACT BACKGROUND: Omalizumab is a humanized monoclonal anti-IgE for the treatment of severe allergic asthma. Because omalizumab targets an immune system molecule there has been particular interest...
Omalizumab for Asthma: Indications, Off-Label Uses and Future Directions.
Omalizumab is a recombinant humanized monoclonal antibody. Use of omalizumab is reported to benefit significantly a subset of asthmatics patients with inadequately controlled moderate-to-severe persis...
Omalizumab: Anti-IgE Therapy in Allergy.
Omalizumab is a humanized, monoclonal anti-IgE antibody that binds specifically to circulating IgE molecules, thus interrupting the allergic cascade. Omalizumab has been shown to be highly effective i...
BACKGROUND: Patients with asthma who have persistent symptoms despite treatment with inhaled steroids and long-acting beta agonists are considered to have severe asthma. Omalizumab is a monoclonal ant...
Safety and tolerability of omalizumab in children with allergic (IgE-mediated) asthma.
Abstract Objective: This pooled analysis assessed the safety of omalizumab in children with allergic (immunoglobulin E-mediated) asthma. Study design: Two double-blind, placebo-controlled studies in c...
