Inner-City Anti-IgE Therapy for Asthma
ICATA
2 other identifiers
interventional
419
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 asthma
Started Oct 2006
Longer than P75 for phase_4 asthma
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2006
CompletedFirst Posted
Study publicly available on registry
September 18, 2006
CompletedStudy Start
First participant enrolled
October 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedResults Posted
Study results publicly available
June 7, 2013
CompletedMarch 21, 2017
February 1, 2017
3.2 years
September 14, 2006
January 11, 2013
February 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum Number of Asthma Symptom Days
Maximum symptom days was calculated as the largest of the following variables: number of days with wheezing, chest tightness, or cough; number of nights of sleep disturbance; and number of days when activities were affected. This symptom scale ranges from 0 to 14 days per a 2-week look-back period. A higher score reflected a greater number of asthma symptoms. Data represent an average of those collected in the time period (weeks 12-60), where at least one value was available in this assessment period and at baseline for a participant.
Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.
Secondary Outcomes (16)
Economic Outcome: Comparison of Number of Missed School Days Due to Asthma
Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.
Economic Outcome: Number of Missed Work Days by Caretaker Due to Asthma
Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.
Child Asthma Control Test (C-ACT) Score
Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of treatment.
Asthma Control Test (ACT) Score
Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.
Forced Expiratory Volume in 1 Second (FEV1) % Predicted
Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.
- +11 more secondary outcomes
Study Arms (2)
Omalizumab (Xolair) + Conventional Therapy
EXPERIMENTALOmalizumab 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.
Placebo + Conventional Therapy
PLACEBO COMPARATORPlacebo 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
University of Arizona Health Sciences Center
Tucson, Arizona, 245018, United States
National Jewish Medical and Research Center
Denver, Colorado, 80206, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Children's Memorial Hospital
Chicago, Illinois, 60614, United States
Boston University School of Medicine
Boston, Massachusetts, 02118, United States
Columbia University Medical Center
New York, New York, 10029, United States
Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Related Publications (6)
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.
PMID: 15180756BACKGROUNDBusse 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.
PMID: 11496232BACKGROUNDMvula 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.
PMID: 15801322BACKGROUNDSzefler 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.
PMID: 15753890BACKGROUNDBusse 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.
PMID: 21410369RESULTSzefler 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.
PMID: 32298853DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director, Clinical Research Program
- Organization
- DAIT/NIAID
Study Officials
- STUDY CHAIR
William W. Busse, MD
University of Wisconsin, Madison
- PRINCIPAL INVESTIGATOR
George T. O'Connor, MD, MS
Boston University
- PRINCIPAL INVESTIGATOR
Jacqueline Pongracic, MD
Ann & Robert H Lurie Children's Hospital of Chicago
- 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 National Research Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2006
First Posted
September 18, 2006
Study Start
October 1, 2006
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
March 21, 2017
Results First Posted
June 7, 2013
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will share
Participant level data and additional relevant materials are available to the public in the Immunology Database and Analysis Portal (ImmPort). ImmPort is a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.