Allergy Immunotherapy for the Reduction of Asthma

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2015-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Wheezing Asthma Allergy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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No immunotherapy, receive standard of care asthma treatment

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

Group Type ACTIVE_COMPARATOR

Standard of care

Intervention Type OTHER

standard of care asthma and allergy treatment

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. In addition to allergy immunotherapy. this group receives standard of care asthma and allergy treatment

Group Type EXPERIMENTAL

Allergen extracts (subcutaneous injections)

Intervention Type BIOLOGICAL

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)

Standard of care

Intervention Type OTHER

standard of care asthma and allergy treatment

Interventions

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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)

Intervention Type BIOLOGICAL

Standard of care

standard of care asthma and allergy treatment

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Months

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No