A Study to Evaluate the Safety of Xolair in Moderate to Severe Persistent Asthma Patients (ALTO)
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This was a multicenter, open label, randomized, controlled, safety trial in subjects aged 6-75 years with a diagnosis of moderate to severe, persistent asthma. A total of 1899 subjects were randomized (2:1) to either the active treatment group or the control group. Upon successful completion of the screening period (~2 weeks), each subject entered the 24 week study.
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Ages Eligible for Study:
6 Years to 75 Years (Child, Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Documented physician diagnosis of moderate to severe, persistent asthma, defined in the National Heart, Lung, and Blood Institute (NHLBI) guidelines as FEV1 < 80% predicted for height, age, and sex or a history of FEV1 < 80%
Between 6 and 75 years old at the time of screening (Visit 1 [Week -2])
Current treatment with the following medications: Moderate doses of any inhaled steroid preparation on a daily basis for at least 30 days prior to screening; and/or oral steroids at a stable dose on a daily basis for at least 30 days prior to screening; and currently treated with at least one of the following drugs on a daily basis at a stable dose for at least 30 days prior to screening: long-acting β-adrenergic (salmeterol), leukotriene receptor antagonist (LTRA), xanthine derivatives, or sodium cromoglycate
Signed informed consent (in the case of a minor, consent must have been given by the child's parent or legal guardian)
Serum IgE level of ≥ 30 IU/mL and ≤ 1300 IU/mL and a body weight ≥ 20 kg and ≤ 150 kg and fell within the protocol-defined dosing table ranges
For females of childbearing potential, in the opinion of the investigator, use of an effective method of contraception to prevent pregnancy and agreement to continue to practice an acceptable method of contraception for the duration of their participation in the study
Willingness to participate fully for the duration of the study
Current active AEE defined as requiring initiation or increase in oral steroid dose or treatment with at least a doubling of inhaled steroid dose
Thrombocytopenia as evidenced by platelets < 100,000/uL
Pregnancy or lactation
Previous randomization in this study
Use of any experimental drug within 30 days prior to study screening
Known hypersensitivity to any ingredients of Xolair, including excipients (sucrose, histidine, polysorbate 20)
Diagnosis of aspirin or nonsteroidal anti-inflammatory drug-induced asthma
Active lung disease other than asthma (e.g., chronic bronchitis, emphysema, cystic fibrosis, chronic obstructive pulmonary disease)
History of smoking within 2 years of the study screening visit or history of smoking ≥ 10 pack years
Significant systemic disease (e.g., infection, hematologic, renal, hepatic, coronary heart disease or other cardiovascular diseases, endocrinologic or gastrointestinal disease) within the previous 3 months
History of neoplasia
History of noncompliance to medical regimens
Any systemic condition requiring regular administration of immunoglobulin