Inner-City Anti-IgE Therapy for Asthma (ICATA)

• Economic outcomes [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
• Asthma-related medical care resource utilization [ Time Frame: Monthly throughout study ] [ Designated as safety issue: No ]
• Asthma exacerbations [ Time Frame: Monthly throughout study ] [ Designated as safety issue: No ]
• Pulmonary Function and Exhaled Nitric Oxide [ Time Frame: At various visits throughout the study ] [ Designated as safety issue: No ]
• Asthma Control Test or Childhood Asthma Control Test [ Time Frame: Monthly throughout study ] [ Designated as safety issue: No ]
• Number of missed school/work days [ Time Frame: Monthly throughout study ] [ Designated as safety issue: No ]
• Asthma-specific quality of life (QOL) [ Time Frame: At various visits throughout the study ] [ Designated as safety issue: No ]
• Asthma medication use, rescue beta-agonist, and inhaled corticosteroids (ICS) use [ Time Frame: At various visits throughout the study ] [ Designated as safety issue: No ]
• Safety [ Time Frame: At every study visit ] [ Designated as safety issue: Yes ]

• Economic outcomes
• asthma-related medical care resource utilization
• school/work attendance
• spirometry measurements
• caretaker and child quality-of-life
• asthma control measurements
• asthma medication use, including ability to reduce inhaled corticosteroids (ICS)

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.

This study is testing a medication called omalizumab for the treatment of asthma. IgE is produced when you are exposed to allergens and can cause inflammation in your 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.

• Drug: Omalizumab
  Subcutaneous injections of omalizumab will be administered every 2 or 4 weeks along with standardized asthma care for 60 weeks, beginning with the Randomization Visit. Dosage is dependent on participant's individual characteristics.
• Biological: Standardized asthma care
  Subcutaneous injections of placebo will be administered every 2 or 4 weeks along with standardized asthma care for 60 weeks, beginning with the Randomization Visit. Dosage is dependent on participant's individual characteristics.

• Experimental: 1
  Subcutaneous injections of omalizumab every 2 or 4 weeks plus standard asthma care
  Intervention: Drug: Omalizumab
• Placebo Comparator: 2
  Subcutaneous injections of placebo every 2 or 4 weeks plus standard asthma care
  Intervention: Biological: Standardized asthma care

• Busse WW, Morgan WJ, Gergen PJ, Mitchell HE, Gern JE, Liu AH, Gruchalla RS, Kattan M, Teach SJ, Pongracic JA, Chmiel JF, Steinbach SF, Calatroni A, Togias A, Thompson KM, Szefler SJ, Sorkness CA. Randomized trial of omalizumab (anti-IgE) for asthma in inner-city children. N Engl J Med. 2011 Mar 17;364(11):1005-15.
• Ayres JG, Higgins B, Chilvers ER, Ayre G, Blogg M, Fox H. Efficacy and tolerability of anti-immunoglobulin E therapy with omalizumab in patients with poorly controlled (moderate-to-severe) allergic asthma. Allergy. 2004 Jul;59(7):701-8.
• Busse W, Corren J, Lanier BQ, McAlary M, Fowler-Taylor A, Cioppa GD, van As A, Gupta N. Omalizumab, anti-IgE recombinant humanized monoclonal antibody, for the treatment of severe allergic asthma. J Allergy Clin Immunol. 2001 Aug;108(2):184-90.
• Mvula M, Larzelere M, Kraus M, Moisiewicz K, Morgan C, Pierce S, Post R, Nash T, Moore C. Prevalence of asthma and asthma-like symptoms in inner-city schoolchildren. J Asthma. 2005 Feb;42(1):9-16.
• Szefler SJ, Apter A. Advances in pediatric and adult asthma. J Allergy Clin Immunol. 2005 Mar;115(3):470-7. Review.

Inclusion Criteria:

• Males and females between the ages of 6 and 20 years
• Both body weight and total serum IgE suitable for omalizumab dosing. More information about this criterion can be found in the protocol.
• Diagnosis of asthma made by a physician more than 1 year prior to study entry OR diagnosis of asthma made less than 1 year prior to study entry but have had asthma symptoms for longer than 1 year prior to study entry
• Are receiving long-term asthma control therapy OR have symptoms consistent with persistent asthma OR have evidence of uncontrolled disease
• Positive prick skin test to at least one perennial allergen (e.g., dust mite, cockroach, mold, cat, dog, rat, mouse)
• Live in a preselected zip code are
• Able to perform spirometry measurements
• Willing to sign informed consent or have parent or guardian willing to provide informed consent
• Previously had chicken pox or received varicella (chicken pox) vaccine
• Have some form of health care insurance that covers costs of medications

Exclusion Criteria:

If participant meets any of these criteria, they are not eligible at that time but may be reassessed:

• Systemic prednisone (or equivalent) during the 2 weeks prior to Visit 2
• Systemic prednisone (or equivalent) for more than 30 of the 60 days prior to study entry
• Pregnancy or breastfeeding
• Acute sinusitis or chest infection requiring antibiotics within 1 month of study screening
• Currently participating in another asthma-related clinical trial or have previously participated in an another asthma-related trial within 1 month of study entry
• Does not sleep at least 4 nights per week in one home
• Lives with a foster parent
• Does not have access to a phone
• Plans to move during the study
• Previously treated with anti-IgE therapy within 1 year of study entry
• Currently receiving or received hyposensitization therapy to any allergen in the year prior to study entry
• Previously received hyposensitization therapy to dust mite, Alternaria, or cockroach for more than 6 months in the 3 years prior to study entry

If participant meets any of these criteria, they are not eligible for the study and may not be reassessed:

• Significant medical illness. More information on this criterion can be found in the protocol.
• Certain medications within 4 weeks of study screening. More information on this criterion can be found in the protocol.
• Known hypersensitivity to any ingredients of omalizumab or related drugs
• Diagnosis of cancer, being investigated for possible cancer, or history of cancer
• Will not allow study physician to manage their asthma
• Does not primarily speak English (or Spanish at centers with Spanish-speaking staff)
• History of severe anaphylactoid or anaphylactic reaction(s)