Six Months, Open Label Study to Assess Safety and Immunogenicity of Omalizumab Liquid Formulation in Adolescents (>12 Years) and Adults With Moderate to Severe Persistent Allergic Asthma
Summary
The primary objective of this study is to assess the immunogenic potential of the liquid formulation of omalizumab administered over a period of 6 months in moderate to severe persistent allergic asthma patients 12 years of age or older, with no previous exposure to the drug (omalizumab naïve patients). The secondary objective of this study is to assess the safety of the liquid formulation of omalizumab in the same patients.
Study Design
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Asthma
Intervention
omalizumab
Location
Allergy & Immunology Associates, Ltd
Scottsdale,
Arizona
United States
AZ 85251
Status
Active, not recruiting
Source
Novartis
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00500539
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
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.
Tretoquinol
An adrenergic beta-agonist used as a bronchodilator agent in asthma therapy.
Isoetharine
Adrenergic beta-2 agonist used as bronchodilator for emphysema, bronchitis and asthma.
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.
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...
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
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...
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...
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...
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...
Background. Omalizumab (Xolair®) is a monoclonal antibody indicated for moderate to severe persistent allergic asthma patients with symptoms that are inadequately controlled with inhaled corticostero...
