Allergy Immunotherapy for the Reduction of Asthma - Full Text View

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:

MedlinePlus related topics: Allergy Asthma

Genetic and Rare Diseases Information Center resources: Children's Interstitial Lung Disease

U.S. FDA Resources

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
Estimated Study Completion Date:	October 2015
Estimated Primary Completion Date:	October 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

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
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

Contacts


Contact: Yikania Pichardo	718 918 6087	yikania.pichardo@nbhn.net
Contact: Gabriele de Vos, MD, MSc	718 918 6087	gabriele.devos@nbhn.net

Locations


United States, New York
Jacobi Medical Center	Recruiting
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:

Abramson MJ, Puy RM, Weiner JM. Allergen immunotherapy for asthma. Cochrane Database Syst Rev. 2003;(4):CD001186. Review. Update in: Cochrane Database Syst Rev. 2010;(8):CD001186.

Roberts G, Hurley C, Turcanu V, Lack G. Grass pollen immunotherapy as an effective therapy for childhood seasonal allergic asthma. J Allergy Clin Immunol. 2006 Feb;117(2):263-8.

Pifferi M, Baldini G, Marrazzini G, Baldini M, Ragazzo V, Pietrobelli A, Boner AL. Benefits of immunotherapy with a standardized Dermatophagoides pteronyssinus extract in asthmatic children: a three-year prospective study. Allergy. 2002 Sep;57(9):785-90.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

de Vos G, Shankar V, Nazari R, Kooragayalu S, Smith M, Wiznia A, Rosenstreich D. Fear of repeated injections in children younger than 4 years receiving subcutaneous allergy immunotherapy. Ann Allergy Asthma Immunol. 2012 Dec;109(6):465-9. doi: 10.1016/j.anai.2012.10.003. Erratum in: Ann Allergy Asthma Immunol. 2013 Mar;110(3):216.


Responsible Party:	Gabriele de Vos, M.D., M.Sc., Albert Einstein College of Medicine and Jacobi Medical Center
ClinicalTrials.gov Identifier:	NCT01028560 History of Changes
Other Study ID Numbers:	CCI# 2007-280
Study First Received:	December 7, 2009
Last Updated:	June 21, 2011
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 Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases	Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

ClinicalTrials.gov processed this record on February 27, 2015

Allergy Immunotherapy for the Reduction of Asthma (AIR)