Inner-City Anti-IgE Therapy for Asthma

NCT ID: NCT00377572

Last Updated: 2017-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 419 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2009-12-31

Brief 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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Omalizumab (Xolair) + Conventional Therapy

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.

Group Type: EXPERIMENTAL

omalizumab

Intervention Type: BIOLOGICAL

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.

Placebo + Conventional Therapy

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.

Group Type: PLACEBO_COMPARATOR

omalizumab placebo

Intervention Type: BIOLOGICAL

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.

Interventions

omalizumab

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.

Intervention Type: BIOLOGICAL

omalizumab placebo

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

Xolair®; Anti-IgE antibody,humanized monoclonal

Eligibility Criteria

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)

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Inner-City Asthma Consortium

NETWORK

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William W. Busse, MD

Role: STUDY_CHAIR

University of Wisconsin, Madison

George T. O'Connor, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Boston University

Jacqueline Pongracic, MD

Role: PRINCIPAL_INVESTIGATOR

Ann & Robert H Lurie Children's Hospital of Chicago

Jamen Chmiel, MD

Role: PRINCIPAL_INVESTIGATOR

Rainbow Babies and Children's Hospital

Rebecca S. Gruchalla, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Andrew Liu, MD

Role: PRINCIPAL_INVESTIGATOR

National Jewish Health

Meyer Kattan, MD, CM

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Wayne Morgan, MD, CM

Role: PRINCIPAL_INVESTIGATOR

University of Arizona Health Sciences Center

Stephen Teach, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Children's National Research Institute

Locations

University of Arizona Health Sciences Center

Tucson, Arizona, United States

National Jewish Medical and Research Center

Denver, Colorado, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

Children's Memorial Hospital

Chicago, Illinois, United States

Boston University School of Medicine

Boston, Massachusetts, United States

Columbia University Medical Center

New York, New York, United States

Rainbow Babies and Children's Hospital

Cleveland, Ohio, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Countries

United States

References

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. doi: 10.1111/j.1398-9995.2004.00533.x.

Reference Type: BACKGROUND

PMID: 15180756 (View on PubMed)

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. doi: 10.1067/mai.2001.117880.

Reference Type: BACKGROUND

PMID: 11496232 (View on PubMed)

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. doi: 10.1081/jas-200044746.

Reference Type: BACKGROUND

PMID: 15801322 (View on PubMed)

Szefler SJ, Apter A. Advances in pediatric and adult asthma. J Allergy Clin Immunol. 2005 Mar;115(3):470-7. doi: 10.1016/j.jaci.2004.12.1123.

Reference Type: BACKGROUND

PMID: 15753890 (View on PubMed)

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. doi: 10.1056/NEJMoa1009705.

Reference Type: RESULT

PMID: 21410369 (View on PubMed)

Szefler SJ, Casale TB, Haselkorn T, Yoo B, Ortiz B, Kattan M, Busse WW. Treatment Benefit with Omalizumab in Children by Indicators of Asthma Severity. J Allergy Clin Immunol Pract. 2020 Sep;8(8):2673-2680.e3. doi: 10.1016/j.jaip.2020.03.033. Epub 2020 Apr 13.

Reference Type: DERIVED

PMID: 32298853 (View on PubMed)

Related Links

https://www.niaid.nih.gov/

National Institute of Allergy and Infectious Diseases (NIAID) website

https://www.niaid.nih.gov/about/dait

Division of Allergy, Immunology, and Transplantation (DAIT) website

Other Identifiers

ICATA

Identifier Type: OTHER

Identifier Source: secondary_id

DAIT ICAC-08

Identifier Type: -

Identifier Source: org_study_id