Preventative Omalizumab or Step-up Therapy for Severe Fall Exacerbations
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this trial is to compare the efficacy of 4 to 5 months of three treatments -
      omalizumab, corticosteroid therapy boost, and placebo - in reducing fall exacerbations in
      inner-city children and adolescents with allergic persistent asthma when initiated
      approximately 4 -6 weeks prior to the start of the first day of each participant's school
      year.
    

Detailed description: 
      While the increase in the prevalence of asthma has abated, levels of asthma morbidity and
      mortality remain near record highs. An asthma exacerbation is a major factor contributing to
      morbidity, and even mortality in patients with asthma. Although current approaches to
      treatment have reduced these risks, asthma exacerbations are major problems for inner-city
      patients and their families, and prevention of these events continues to be a significant
      challenge. In children with asthma, there are predictable seasonal epidemics of
      exacerbations, especially during the fall season, otherwise known as the "September
      epidemic."
    

Intervention name(s): Omalizumab; Inhaled Corticosteroid Boost Therapy (ICS); Placebo omalizumab; Placebo fluticasone
Intervention type(s): Biological; Drug; Biological; Biological
Intervention description(s): Participants received active omalizumab (Xolair(R)) injections and a placebo inhaler. Each participant received omalizumab (Xolair(R)) subcutaneous injections at minimum dose of 0.016 mg/kg/IgE (immunoglobulin E) [IU/mL] every 2 or 4 weeks during the 4-5 months treatment period. All participants received standardized specialist asthma care.; Self-administered fluticasone (Flovent ® Diskus®) inhalers sufficient to deliver the required 200 mcg or 500 mcg daily boost of fluticasone. All participants will receive standardized specialist asthma care.; Placebo was administered subcutaneously every 2 or 4 weeks over a period of 4 to 5 months. Doses (mg) and dosing frequency were determined by serum total immunoglobulin E (IgE) level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP, 2007) guidelines, under the management of an asthma specialist health care provider.; Self-administered placebo fluticasone (placebo Flovent ® Diskus®) inhalers identical in dose and guidance as active fluticasone. All participants will receive standardized specialist asthma care.
Other intervention name(s): Xolair®; Flovent® Diskus®; Placebo Xolair®; Placebo Flovent® Diskus®
Intervention MeSH terms: Fluticasone; Xhance; Omalizumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: persistent allergic asthma; asthma exacerbations reduction; Xolair® (omalizumab); Flovent® Diskus® (fluticasone); placebo; inhaled corticosteroid therapy; anti-immunoglobulin E therapy; anti-IgE therapy