Clinical trial NCT00377572: Inner-City Anti-IgE Therapy for Asthma
Official title: Inner-City Anti-IgE Therapy for Asthma (ICAC-08)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: Immunoglobulins
Immunoglobulin E
omalizumab
anti-IgE
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Inner-City Asthma Consortium
First posted: 2006-09-18
Enrollment: 419
Sex: ALL
Minimum age (years): 6
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Maximum Number of Asthma Symptom Days
timeFrame: Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.
Secondary outcomes:
measure: Economic Outcome: Comparison of Number of Missed School Days Due to Asthma
timeFrame: Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.
measure: Economic Outcome: Number of Missed Work Days by Caretaker Due to Asthma
timeFrame: Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.
measure: Child Asthma Control Test (C-ACT) Score
timeFrame: Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of treatment.
measure: Asthma Control Test (ACT) Score
timeFrame: Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.
measure: Forced Expiratory Volume in 1 Second (FEV1) % Predicted
timeFrame: Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.
measure: FEV1/FVC Ratio
timeFrame: Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.
measure: Exhaled Nitric Oxide
timeFrame: Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.
measure: Percent Adherence to Asthma Medication
timeFrame: Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment
measure: Percent Prevalence: Treatment Step Level 1 or 2 (Mild Asthma)
timeFrame: Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment
measure: Percent Prevalence: Treatment Step Level 4 Through 6 (Severe Asthma)
timeFrame: Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment
measure: Dose Inhaled Corticosteroids (Glucocorticoids)
timeFrame: Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.
measure: Percent Prevalence: Prescribed Rescue Beta 2 Agonists
timeFrame: Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.
measure: Percent Prevalence: Asthma-Related Medical Care Resource Utilization - Hospitalizations
timeFrame: Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.
measure: Percent Prevalence: Asthma Exacerbations
timeFrame: Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.
measure: Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) Overall Score
timeFrame: Week 60
measure: Paediatric Asthma Quality of Life Questionnaire (PAQLQ) Overall Score
timeFrame: Week 60
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Health Sciences Center
state: Arizona
city: Denver
country: United States
facility: National Jewish Medical and Research Center
state: Colorado
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Chicago
country: United States
facility: Children's Memorial Hospital
state: Illinois
city: Boston
country: United States
facility: Boston University School of Medicine
state: Massachusetts
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Cleveland
country: United States
facility: Rainbow Babies and Children's Hospital
state: Ohio
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: University of Wisconsin, Madison
name: William W. Busse, MD
role: STUDY_CHAIR
affiliation: Boston University
name: George T. O'Connor, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
name: Jacqueline Pongracic, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rainbow Babies and Children's Hospital
name: Jamen Chmiel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas Southwestern Medical Center
name: Rebecca S. Gruchalla, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Jewish Health
name: Andrew Liu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Meyer Kattan, MD, CM
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Arizona Health Sciences Center
name: Wayne Morgan, MD, CM
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's National Research Institute
name: Stephen Teach, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.