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)”

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.

Intervention(s) in this Clinical Trial

• 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, Groups and Cohorts in this Clinical Trial

• 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
• 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

Primary Measures

• Combined asthma symptom and asthma medication score
  • Time Frame: After 3 years of immunotherapy
    Safety Issue?: No

Secondary 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
    Safety Issue?: No
• Observe Frequency and Phenotype of T regulatory cells in response to immunotherapy
  • Time Frame: After 1 and 3 years of immunotherapy
    Safety Issue?: 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Months

Maximum Age for this Clinical Trial: 3 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Albert Einstein College of Medicine of Yeshiva University Other

Overall Clinical Trial Officials and Contacts

Gabriele de Vos, M.D., M.Sc. Principal Investigator Einstein, Jacobi Medical Center  

Overall Contact: Yikania Pichardo 718 918 6087 yikania.pichardo@nbhn.net

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01028560

Study ID Number: CCI# 2007-280

ClinicalTrials.gov Identifier: NCT01028560

Health Authority: United States: Food and Drug Administration