Allergy Immunotherapy for the Reduction of Asthma
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Allergy, Asthma, Neurology, Pulmonary |
| Therapuetic Areas: | Neurology, Otolaryngology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | Any - 3 |
| Updated: | 7/14/2018 |
| Start Date: | October 2008 |
| End Date: | August 11, 2018 |
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.
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.
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.
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