Allergy Immunotherapy for the Reduction of Asthma (AIR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Jacobi Medical Center
Information provided by (Responsible Party):
Gabriele de Vos, Albert Einstein College of Medicine, Inc.

Brief Summary:
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 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Asthma

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
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

Primary Outcome Measures :
  1. Combined asthma symptom and asthma medication score [ Time Frame: After 3 years of immunotherapy ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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).
  • 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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01028560

United States, New York
Jacobi Medical Center
Bronx, New York, United States, 10461
Sponsors and Collaborators
Albert Einstein College of Medicine, Inc.
Jacobi Medical Center
Principal Investigator: Gabriele de Vos, M.D., M.Sc. Einstein, Jacobi Medical Center

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Gabriele de Vos, Assistant Professor of Medicine (Allergy and Immunology), Albert Einstein College of Medicine, Inc. 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, Inc.:

Additional relevant MeSH terms:
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