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
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.
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Allergy & Immunology Associates, Ltd
Active, not recruiting
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00500539
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
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).
Drugs that are used to treat asthma.
A beta-adrenergic agonist used in the treatment of asthma and bronchospasms.
An adrenergic beta-agonist used as a bronchodilator agent in asthma therapy.
Adrenergic beta-2 agonist used as bronchodilator for emphysema, bronchitis and 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.
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