Allergy Immunotherapy for the Reduction of Asthma (AIR)
This study has suspended participant recruitment.
(No evidence of clinically meaningful benefits for asthma (reduction of asthma medication scores and symptoms) in preliminary analysis)
Sponsor:
Albert Einstein College of Medicine of Yeshiva University
Collaborator:
Jacobi Medical Center
Information provided by (Responsible Party):
Gabriele de Vos, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT01028560
First received: December 7, 2009
Last updated: June 29, 2015
Last verified: June 2015
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Purpose
In this clinical study we aim to determine the effect of allergy immunotherapy in decreasing asthma and allergy related disease in children who had multiple episodes of wheezing and who are at high risk for developing persisting asthma. These risks include a history of asthma in the parents, allergies to environmental allergens (such as dust mite, cockroach or mouse) and other allergic diseases such as eczema or food allergies. Allergy Immunotherapy is not new and has been practiced for many years to treat asthma and environmental allergies in older children and adults, but has not yet been systematically studied in young children.
| Condition | Intervention | Phase |
|---|---|---|
|
Wheezing Asthma Allergy |
Biological: Allergen extracts (subcutaneous injections) Other: Standard of care |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Efficacy of Allergy Immunotherapy in Preventing Asthma Morbidity in Atopic, Wheezing Children (Age 18 Months - 3 Years) |
Resource links provided by NLM:
Further study details as provided by Albert Einstein College of Medicine of Yeshiva University:
Primary Outcome Measures:
- Combined asthma symptom and asthma medication score [ Time Frame: After 3 years of immunotherapy ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Prevention of new allergic sensitization as determined by blood and/or skin testing to a panel of 9 common environmental and 9 common food allergens [ Time Frame: After 1 and 3 years of immunotherapy ] [ Designated as safety issue: No ]
- Observe Frequency and Phenotype of T regulatory cells in response to immunotherapy [ Time Frame: After 1 and 3 years of immunotherapy ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | October 2008 |
| Primary Completion Date: | April 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: No immunotherapy
This group consists of children who do not receive allergy immunotherapy. Both groups - the experimental as well as the control group receive otherwise standard of care asthma and allergy treatment
|
Other: Standard of care
standard of care asthma and allergy treatment
|
|
Experimental: Allergen immunotherapy
This group receives initially weekly, later biweekly subcutaneous injections of a mixture of allergen extracts, tailored to the individual child's allergy sensitization profile. The maximum number of injections at each visit is 1-3 injections per child
|
Biological: Allergen extracts (subcutaneous injections)
Allergy immunotherapy consists of regular subcutaneous injections of an individualized mixture of allergen extracts according to the allergy sensitization profile of each child. Increasing doses of allergen extract are given in 1-2 injections until a predetermined maintenance dose is reached. This maintenance dose varies by extract and accords to the general practice guidelines of immunotherapy. To increase safety the cumulative monthly maintenance doses are divided into biweekly visits during the maintenance phase (year 2-3)
Other: Standard of care
standard of care asthma and allergy treatment
|
Eligibility| Ages Eligible for Study: | 18 Months to 3 Years (Child) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Children between 18 months through 3 years who had at least 2 episodes of wheezing prior to enrolment.
- Positive skin tests or specific IgE antibody titers to at least one of common airborne allergens: Dust Mite, cat, cockroach, mouse, dog, pollen (all allergy testing can be done at the screening visit at the study site).
-
The child must also fulfill the criteria for high risk of developing persistent asthma by meeting at least one of the following major conditions OR 2 of the following minor conditions:
- Major criteria: History of atopic dermatitis and/or parental history of asthma.
- Minor criteria: MD-diagnosed allergic rhinitis, wheezing unrelated to colds, blood eosinophils above 4%.
Exclusion Criteria:
- The child has a severe systemic condition (other than allergy or asthma) including (but not limited to) seizures, major congenital anomalies, physical and intellectual delay, cerebral palsy, chest surgery, tuberculosis, primary or secondary immunodeficiency or cardiac disorder (except a hemodynamically insignificant ASD, VSD or heart murmur).
- The child was born following 35 or less weeks of gestation.
- Parental report that the child received oxygen for more than 5 days in the neonatal period, or required mechanical ventilation at any time since birth.
- The child fails to thrive, defined as crossing of two major growth percentile lines during the last year.
- The child has chronic lung disease of prematurity (CLDP), cystic fibrosis or any other chronic lung disease.
- The child ever received immunotherapy.
- The child ever received i.v. gammaglobulins or immunosuppressants (other than corticosteroids for asthma).
- History of a life-threatening asthma exacerbation which required intubation and mechanical ventilation.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01028560
Please refer to this study by its ClinicalTrials.gov identifier: NCT01028560
Locations
| United States, New York | |
| Jacobi Medical Center | |
| Bronx, New York, United States, 10461 | |
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
Jacobi Medical Center
Investigators
| Principal Investigator: | Gabriele de Vos, M.D., M.Sc. | Einstein, Jacobi Medical Center |
More Information
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Gabriele de Vos, Assistant Professor of Medicine (Allergy and Immunology), Albert Einstein College of Medicine of Yeshiva University |
| ClinicalTrials.gov Identifier: | NCT01028560 History of Changes |
| Other Study ID Numbers: | CCI# 2007-280 |
| Study First Received: | December 7, 2009 |
| Last Updated: | June 29, 2015 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Albert Einstein College of Medicine of Yeshiva University:
|
Wheezing Asthma Allergy Immunotherapy |
Additional relevant MeSH terms:
|
Asthma Hypersensitivity Respiratory Sounds Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive |
Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Signs and Symptoms, Respiratory Signs and Symptoms |
ClinicalTrials.gov processed this record on September 28, 2016