NCT01028560

Allergy Immunotherapy for the Reduction of Asthma

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Albert Einstein College of Medicine · Academic / Other
• Sex: All
• Age: 18 Months – 3 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Wheezing
• Asthma
• Allergy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-10-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2009-12-09
• Last updated: 2019-05-28
• Results posted: 2019-05-28

Locations

1 site across 1 country: United States