The Inner-City Anti-IgE Therapy for Asthma (ICATA) Study was a randomized, double-blind, placebo-controlled, parallel-group, multicenter trial of omalizumab in 419 inner-city children, adolescents, and young adults (6 to 20 years of age) with persistent allergic asthma. A physician’s diagnosis of asthma or documentation of symptoms of asthma for more than 1 year before study entry was required. Patients receiving long-term therapy for disease control were also required to have symptoms of persistent asthma or evidence of uncontrolled disease as indicated by hospitalization or unscheduled urgent care in the 6 to 12 months preceding study entry. Those not receiving long-term control therapy were eligible for enrollment only if they had both persistent symptoms and uncontrolled asthma. In addition, all patients were required to have at least one positive skin test for a perennial allergen, to weigh between 20 and 150 kg, and have total serum levels of IgE between 30 and 1300 IU per milliliter.
The protocol, which includes the statistical analysis plan, was approved by the institutional review boards of all participating institutions and is available with the full text of this article at NEJM.org. Written informed consent was obtained from each participant or the participant’s parent or legal guardian. Participants who were younger than 18 years of age provided assent.
The protocol, which includes the statistical analysis plan, was approved by the institutional review boards of all participating institutions and is available with the full text of this article at NEJM.org. Written informed consent was obtained from each participant or the participant’s parent or legal guardian. Participants who were younger than 18 years of age provided assent.
