Allergy Immunotherapy for the Reduction of Asthma (AIR)
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ClinicalTrials.gov Identifier: NCT01028560 |
Recruitment Status
:
Suspended
(No evidence of clinically meaningful benefits for asthma (reduction of asthma medication scores and symptoms) in preliminary analysis)
First Posted
: December 9, 2009
Last Update Posted
: July 1, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Wheezing Asthma Allergy | Biological: Allergen extracts (subcutaneous injections) Other: Standard of care | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Efficacy of Allergy Immunotherapy in Preventing Asthma Morbidity in Atopic, Wheezing Children (Age 18 Months - 3 Years) |
Study Start Date : | October 2008 |
Actual Primary Completion Date : | April 2015 |
Arm | Intervention/treatment |
---|---|
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
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Other: Standard of care
standard of care asthma and allergy treatment
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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
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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
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- Combined asthma symptom and asthma medication score [ Time Frame: After 3 years of immunotherapy ]
- 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 ]
- Observe Frequency and Phenotype of T regulatory cells in response to immunotherapy [ Time Frame: After 1 and 3 years of immunotherapy ]

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Ages Eligible for Study: | 18 Months to 3 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01028560
United States, New York | |
Jacobi Medical Center | |
Bronx, New York, United States, 10461 |
Principal Investigator: | Gabriele de Vos, M.D., M.Sc. | Einstein, Jacobi Medical Center |
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 |
First Posted: | December 9, 2009 Key Record Dates |
Last Update Posted: | July 1, 2015 |
Last Verified: | June 2015 |
Keywords provided by Gabriele de Vos, 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 |