Efficacy of Omalizumab in Adults (18-60 Years of Age) With Moderate-Severe, Persistent Allergic Asthma, Despite Receiving Inhaled Corticosteroids and Long Acting Beta-agonists
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Keep this study
Lead
Novartis Pharmaceuticals
With
Genentech, Inc.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients 18-75 years of age with moderate to severe persistent allergic asthma receiving a high dose inhaled corticosteroid (≥800µg per day BDP or equivalent) and a regular long acting beta-agonist for at least 3 months prior to screening
With a body weight between 20 and 150kg and a serum total IgE level of 30 to 700 IU/mL
With ≥2% eosinophilia in induced sputum at screening
With post-bronchodilator forced expiratory volume in 1 second (FEV1) ≥60% predicted
With a positive skin prick test (diameter of wheal ≥ 3 mm) or RAST test to at least one perennial aero-allergen (eg. dust mite, cat/dog dander, cockroaches), documented within the past 2 years or demonstrated at Visit 1, to which the patient will be exposed on a regular basis (most days) for the duration of the study.
You may not be if
Patients who've had an asthma exacerbation during the 4 weeks prior to randomization
Current smokers, stopped smoking within the last 12 months or have a smoking history of \>10 pack years
History of severe allergy to food or drugs
Previous treatment with omalizumab
Any patient considered to be unsuitable to bronchoscopy, according to the judgment of the investigator
Clareo Health | Efficacy of Omalizumab in Adults (18-60 Years of Age) With Moderate-Severe, Persistent Allergic Asthma, Despite Receiving Inhaled Corticosteroids and Long Acting Beta-agonists
