Inner-City Anti-IgE Therapy for Asthma - Full Text View

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator:	Inner-City Asthma Consortium
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00377572

Purpose

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.

Condition	Intervention	Phase
Asthma	Drug: Omalizumab Biological: Standardized asthma care	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment
Official Title:	Inner-City Anti-IgE Therapy for Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Omalizumab

U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:

Maximum number of asthma symptoms days [ Time Frame: Monthly throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Enrollment:	419
Study Start Date:	October 2006
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Subcutaneous injections of omalizumab every 2 or 4 weeks plus standard asthma care	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.
Placebo Comparator: 2 Subcutaneous injections of placebo every 2 or 4 weeks plus standard asthma care	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.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	6 Years to 20 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00377572

Locations

United States, Arizona
University of Arizona Health Sciences Center
Tucson, Arizona, United States, 245018
United States, Colorado
National Jewish Medical and Research Center
Denver, Colorado, United States, 80206
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Illinois
Children's Memorial Hospital
Chicago, Illinois, United States, 60614
United States, Massachusetts
Boston University School of Medicine
Boston, Massachusetts, United States, 02118
United States, New York
Columbia University Medical Center
New York, New York, United States, 10029
United States, Ohio
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Inner-City Asthma Consortium

Investigators

Study Chair:	William W. Busse, MD	University of Wisconsin Hospital and Clinics
Principal Investigator:	George T. O'Connor, MD, MS	Boston University
Principal Investigator:	Jacqueline Pongracic, MD	Children's Memorial Hospital
Principal Investigator:	Jamen Chmiel, MD	Rainbow Babies and Children's Hospital
Principal Investigator:	Rebecca S. Gruchalla, MD, PhD	University of Texas Southwestern Medical Center
Principal Investigator:	Andrew Liu, MD	National Jewish Health
Principal Investigator:	Meyer Kattan, MD, CM	Columbia University
Principal Investigator:	Wayne Morgan, MD, CM	University of Arizona Health Sciences Center
Principal Investigator:	Stephen Teach, MD, MPH	Children's Research Institute

More Information

Publications:

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.

Responsible Party:	Associate Director, Clinical Research Program, DAIT/NIAID
ClinicalTrials.gov Identifier:	NCT00377572 History of Changes
Other Study ID Numbers:	DAIT ICAC-08, Inner-City Asthma Consortium
Study First Received:	September 14, 2006
Last Updated:	September 12, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Immunoglobulin
IgE
Immune globulin
Omalizumab

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity

Immune System Diseases
Omalizumab
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on May 22, 2012