William W. Busse , M. Morgan , M. Gergen , M. Mitchell , Ph. Gern , M. Liu , M. Gruchalla , M. Teach , M. Pongracic , M. Chmiel , M. Steinbach , M. Thompson , R. Szefler , M. Sorkness , Pharm. Author information Copyright and License information Disclaimer. Address reprint requests to Dr. Copyright notice. The publisher's final edited version of this article is available at N Engl J Med. See other articles in PMC that cite the published article.
Associated Data Supplementary Materials Supplement1. METHODS We enrolled inner-city children, adolescents, and young adults with persistent asthma in a randomized, double-blind, placebo-controlled, parallel-group trial at multiple centers to assess the effectiveness of omalizumab, as compared with placebo, when added to guidelines-based therapy. Table 3 Number of Adverse Events. Open in a separate window. Table 1 Characteristics of Study Participants at Randomization.
P values for the comparison of means and percentages were calculated with the use of the Wilcoxon rank-sum test for continuous variables and the chi-square test for categorical variables. A score of 19 or less on either test indicates that asthma is not well controlled. This symptom scale ranges from 0 to 14 days per 2-week period. Figure 1. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity; these steps are provided in full in the Supplementary Appendix and are summarized here.
Figure 2. SAFETY The observation procedures followed after injection of omalizumab were in accordance with published recommendations. Supplementary Material Supplement1 Click here to view. References 1. Results of a home-based environmental intervention among urban children with asthma. Management of asthma based on exhaled nitric oxide in addition to guideline-based treatment for inner-city adolescents and young adults: a randomised controlled trial.
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Down-regulation of Fc epsilon RI expression on human basophils during in vivo treatment of atopic patients with anti-IgE antibody. Anti-IgE omalizumab inhibits late-phase reactions and inflammatory cells after repeat skin allergen challenge. Support Center Support Center. External link. Please review our privacy policy. Caretaker completed high school — no. C-ACT score in the previous month, age 4 to 11 yr.
ACT score in the previous month, age 12 yr or older. Asthma-related symptoms — no. Missed school — no. Medication — no. We enrolled participants, aged years, with multifood allergies validated by double-blind, placebo-controlled food challenges to their offending foods.
Exclusion criteria included eosinophilic oesophagitis and severe asthma. These individuals were not randomised and received neither omalizumab nor oral immunotherapy. Omalizumab or placebo was administered subcutaneously for 16 weeks, with oral immunotherapy starting at week 8, and was stopped 20 weeks before the exit double-blind, placebo-controlled food challenge at week The primary endpoint was the proportion of participants who passed double-blind, placebo-controlled food challenges to at least two of their offending foods.
This completed trial is registered with ClinicalTrials. Findings: Between March 25, , and Aug 18, , participants were assessed for eligibility, of whom 84 did not meet the inclusion criteria and 21 declined to participate.
We enrolled and randomised 48 eligible participants and the remaining 12 patients were included as nonrandomised, untreated controls.
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