Allergy Immunotherapy for the Reduction of Asthma

Completed · Phase 1/Phase 2

Conditions studied: Wheezing, Asthma, Allergy

In brief

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.

Key facts

Study ID

NCT01028560

Run by

Albert Einstein College of Medicine

People needed

58

Starts

2008-10-01

Expected to finish

2015-04-01

Last updated by the study team

2019-05-28

Who can join

Age: 2 and older, up to 3. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%.

You may not qualify if…

• 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.

Where it is running

• Jacobi Medical Center — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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