Allergy Immunotherapy for the Reduction of Asthma

Condition(s) targeted: Wheezing; Asthma; Allergy

Intervention: Allergen extracts (subcutaneous injections) (Biological); Standard of care (Other)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: Albert Einstein College of Medicine of Yeshiva University

Official(s) and/or principal investigator(s):
Gabriele de Vos, M.D., M.Sc., Principal Investigator, Affiliation: Einstein, Jacobi Medical Center

Overall contact:
Yikania Pichardo, Phone: 718 918 6087, Email: yikania.pichardo@nbhn.net

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.

Official title: Efficacy of Allergy Immunotherapy in Preventing Asthma Morbidity in Atopic, Wheezing Children (Age 18 Months - 3 Years)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Combined asthma symptom and asthma medication score

Secondary outcome:

Prevention of new allergic sensitization as determined by skin testing to a panel of 9 common environmental and 9 common food allergens

Observe Frequency and Phenotype of T regulatory cells in response to immunotherapy

Minimum age: 18 Months. Maximum age: 3 Years. Gender(s): Both.

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.

Yikania Pichardo, Phone: 718 918 6087, Email: yikania.pichardo@nbhn.net

Jacobi Medical Center, Bronx, New York 10461, United States; Recruiting

Related publications:

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

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.

Starting date: October 2008
Last updated: December 8, 2009