CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 58 enrolled
Drug / intervention
Allergen extracts (subcutaneous injections) +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01028560
NCT01028560Phase 2Completed

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

Albert Einstein College of Medicine·interventional·Posted Dec 9, 2009·Updated May 28, 2019

In Brief

A Phase 2 clinical trial evaluating Allergen extracts (subcutaneous injections) and Standard of care for Wheezing and 2 related conditions. Completed, enrolled 58 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsWheezing, Asthma, Allergy
CountriesUnited States

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 9, 2009
Enrollment StartOct 1, 2008
Primary CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 16.6 years ago

Interventions

Allergen extracts (subcutaneous injections)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 careother

standard of care asthma and allergy treatment