Clinical trial NCT01028560: Allergy Immunotherapy for the Reduction of Asthma
Official title: Efficacy of Allergy Immunotherapy in Preventing Asthma Morbidity in Atopic, Wheezing Children (Age 18 Months - 3 Years)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Wheezing
Asthma
Allergy
Keywords: Wheezing
Asthma
Allergy
Immunotherapy
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: Jacobi Medical Center
First posted: 2009-12-09
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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 Immunoglobulin E (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 atrial or ventricular septum defect 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.

Primary outcomes:
measure: Asthma Severity as Measured by the Asthma Severity Score (Averaged up to 36 Months)
timeFrame: baseline and every two weeks up to end of study (up to 36 months)
Secondary outcomes:
measure: Number of Newly Gained Allergic Sensitizations as Assessed by Serum Specific Immunoglobulin E (IgE) Testing
timeFrame: Baseline and end of treatment (36 months)
measure: Peripheral Blood T Regulatory Cells as a Percentage of CD4+ (Cluster of Differentiation 4) Cells
timeFrame: Baseline and every 12 months until end of treatment (36 months)
measure: Incidence Rate of Systemic Corticosteroid Bursts (CSB) Per Child
timeFrame: From baseline through end of study (maximum 36 months)
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
Study officials:
affiliation: Einstein, Jacobi Medical Center
name: Gabriele de Vos, M.D., M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abramson MJ, Puy RM, Weiner JM. Allergen immunotherapy for asthma. Cochrane Database Syst Rev. 2003;(4):CD001186. doi: 10.1002/14651858.CD001186.
citation: 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. doi: 10.1016/j.jaci.2005.09.054.
citation: 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. doi: 10.1034/j.1398-9995.2002.23498.x.
citation: de Vos G, Viswanathan S, Pichardo Y, Nazari R, Jorge Y, Ren Z, Serebrisky D, Rosenstreich D, Wiznia A. A randomized trial of subcutaneous allergy immunotherapy in inner-city children with asthma less than 4 years of age. Ann Allergy Asthma Immunol. 2021 Apr;126(4):367-377.e5. doi: 10.1016/j.anai.2020.12.016. Epub 2021 Jan 6.
citation: de Vos G, Nazari R, Ferastraoaru D, Parikh P, Geliebter R, Pichardo Y, Wiznia A, Rosenstreich D. Discordance between aeroallergen specific serum IgE and skin testing in children younger than 4 years. Ann Allergy Asthma Immunol. 2013 Jun;110(6):438-43. doi: 10.1016/j.anai.2013.03.006. Epub 2013 Apr 11.
citation: 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.