Omalizumab in Adult and Adolescent Patients With Severe Persistent Allergic Asthma
Summary
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 omalizumab over time will be assessed by physicians and patients evaluating the overall improvement in control of their asthma.
THIS STUDY IS NOT ENROLLING PATIENTS IN THE US.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Asthma
Intervention
omalizumab, optimized asthma therapy
Location
Bruxelles
Belgium
Status
Active, not recruiting
Source
Novartis
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00264849
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Tretoquinol
An adrenergic beta-agonist used as a bronchodilator agent in asthma therapy.
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).
Medication Therapy Management
Assistance in managing and monitoring drug therapy for patients receiving treatment for cancer or chronic conditions such as asthma and diabetes, consulting with patients and their families on the proper use of medication; conducting wellness and disease prevention programs to improve public health; overseeing medication use in a variety of settings.
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
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.
Efficacy of Omalizumab as Add on Therapy for Minority Patients With Moderate to Severe Asthma
This study will be a randomized, placebo controlled, double blind study to measure the safety and efficacy of a new, injectable asthma medication, omalizumab, in a group of minority with m...
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
The purpose of this study is to determine whether the addition of omalizumab in patients with poorly controlled asthma (because of poor adherence) will decrease allergic airway inflammatio...
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
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...
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...
Anti-IgE - emerging opportunities for Omalizumab.
Introduction: Omalizumab is a recombinant DNA-derived humanized IgG1 monoclonal antibody that selectively binds to free and membrane-bound immunoglobulin E (IgE) antibodies. Omalizumab has been licens...
Effects of Omalizumab in Non-Atopic Asthma: Results from a Spanish Multicenter Registry.
Aim. To evaluate the effectiveness of omalizumab in non-atopic asthma. Methods. Using data from a multicenter registry of severe asthma, we evaluated and compared the clinical outcome of 29 omalizumab...
THE EFFICACY OF SHORTENING AN ADMINISTRATION PERIOD WITH OMALIZUMAB.
A 64-year old male who had been treated with oral predisolone for severe bronchial asthma had started the treatment of omalizumab administration every 4 weeks since December 2009 and his symptoms had...
