Inner-City Anti-IgE Therapy for Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to find out if adding omalizumab to standard asthma treatment
      results in a safer, more effective, and longer lasting asthma treatment strategy than
      standard treatment alone, in inner-city children with mild to severe asthma.
    

Detailed description: 
      This study is testing a medication called omalizumab for the treatment of asthma.
      Immunoglobulin E (IgE) is produced when one is exposed to allergens and it can cause
      inflammation in the lungs. Omalizumab can reduce inflammation and asthma attacks by blocking
      IgE. Unlike other medications for asthma, omalizumab is not an inhaler medication or pill.
      Instead, omalizumab is dissolved in a liquid and given by injection.

      Studies indicate that people living in the inner-city areas are more likely to be exposed to
      indoor allergens that are difficult to avoid than people living in other areas. The purpose
      of this study is to find out if adding omalizumab to standard asthma treatment results in a
      safer, more effective, and longer lasting asthma treatment strategy than standard treatment
      alone.

      This study will recruit inner-city children and adolescents with moderate to severe allergic
      asthma. This study will last about 1.5 to 2 years. Participants will be randomly assigned to
      receive either omalizumab or placebo injections once every 2 or 4 weeks. The injection
      schedule will be determined based on the participant's weight and total IgE. Both groups will
      receive standardized specialist care and basic asthma education including environmental
      control measures. Participants must have some form of health care insurance to cover the
      costs of asthma controller medications prescribed during the study.

      Participants will complete a series of questionnaires about topics including perceived
      stress, home environment, physical activity, diet and nutrition, smoking habits, and quality
      of life. At study entry and monthly throughout the study, participants will complete
      questionnaires about their asthma symptoms and medical resource utilization. Some visits will
      include a physical examination, vital signs measurement, lung function tests, asthma
      medication evaluation, and an asthma action plan. Blood collection is required up to eight
      times during the study for safety labs.
    

Intervention name(s): omalizumab; omalizumab placebo
Intervention type(s): Biological; Biological
Intervention description(s): Subcutaneous injections of omalizumab will be administered every 2 or 4 weeks along with standard of care for asthma for 60 weeks, beginning with the Randomization Visit. Dosage is dependent on participant's individual characteristics.; Subcutaneous injections of placebo will be administered every 2 or 4 weeks along with standard of care for asthma for 60 weeks, beginning with the Randomization Visit. Dosage is dependent on participant's individual characteristics.
Other intervention name(s): Xolair®; Anti-IgE antibody,humanized monoclonal
Intervention MeSH terms: Omalizumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Immunoglobulins; Immunoglobulin E; omalizumab; anti-IgE