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

National Institute of Allergy and Infectious Diseases (NIAID)

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Biological: omalizumab; Biological: omalizumab placebo

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00377572

ICATA (Other Identifier)

DAIT ICAC-08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 419 patients

Sex: All

Ages: 6 to 20 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Both body weight and total serum IgE suitable for omalizumab dosing.
• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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419 participants in 2 patient groups, including a placebo group

Omalizumab (Xolair) + Conventional Therapy

Experimental group

Description:

Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total 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-II, 2002) guidelines, under the management of an asthma specialist health care provider.

Treatment:

Biological: omalizumab

Placebo + Conventional Therapy

Placebo Comparator group

Description:

Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total 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-II, 2002) guidelines, under the management of an asthma specialist health care provider.

Treatment:

Biological: omalizumab placebo