This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The goal of the study was to evaluate the efficacy of omalizumab compared to placebo, when administered to inner-city children and adolescents with moderate-to-severe allergic asthma receiving standardized specialist care and basic asthma education. Anti-IgE, omalizumab, as a new and novel treatment for asthma represents an opportunity to answer current concerns regarding adverse effects of ICS use in children, treatment of more severe asthma in children allowing lower dose ICS, reducing exacerbations, and, improving the quality of life in relation to asthma. All of this is particularly relevant to children living in urban communities where increased asthma morbidity is documented. Adherence to prescribed medications required to be administered daily is low in inner-city children. Anti-IgE is an injection therapy and has the benefit of being an administered and observed therapy. Finishing in December 2009, he Inner-City Asthma Consortium conducted a randomized, double-blind, placebo-controlled, parallel group efficacy and safety trial designed to compare inner-city children and adolescents age 6-20 years old with moderate-to-severe allergic asthma receiving standardized specialist care, including basic asthma education, with similar children and adolescents receiving comparable standardized specialist care and treatment with omalizumab .Over a 60-week period, participants received subcutaneous injections of omalizumab or placebo every two or four weeks, along with standardized specialist care. After the double-blind, placebo-controlled treatment period, all consenting participants were enrolled in an open-label 24 week treatment period with omalizumab. A final post-treatment evaluation was conducted approximately 16 weeks following the final injection. ICATA was designed as a """"""""real-world"""""""" trial of the effectiveness of omalizumab in urban children and adolescents with moderate-to-severe allergic asthma. The study results may change the paradigm of management for persistent allergic asthma that could be particularly beneficial for children living in the inner-city where there appear to be unique characteristics, such as allergen exposure and poor adherence to therapy. The primary endpoint was the maximum number of asthma symptom days defined as the highest value among three variables: number of days with wheezing, tightness in the chest, or cough;number of nights with disturbed sleep due to asthma;and number of days on which the participant had to slow down or discontinue play/physical activities over a two-week period.
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