A Study of Sublingual Immunotherapy in Peanut-allergic Children

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2016-03-31

Brief Summary

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The specific aim of this study is to determine if peanut allergen-specific SLIT will cause clinical desensitization and tolerance to develop in peanut-allergic young children.

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Detailed Description

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In spite of increased recognition and understanding of food allergies, food-induced anaphylaxis remains the single most common cause of anaphylaxis seen in hospital emergency departments, accounting for about one third of anaphylaxis cases seen. It is estimated that about 30,000 food-induced anaphylactic events are seen in U.S. emergency departments each year and that about 200 fatal cases occur in the U.S. each year. Either peanuts or tree nuts cause more than 80% of these reactions. No treatments are available and avoidance is the only approved intervention.

The goal of this study is to investigate peanut sublingual immunotherapy (SLIT) as a treatment for children with peanut allergy. This study is primarily designed to evaluate the efficacy and safety of peanut SLIT compared to placebo after 12 months. Secondarily, the study is designed to evaluate the efficacy of extended maintenance dosing of peanut SLIT in inducing lasting tolerance after discontinuation of the peanut SLIT. Mechanistic studies will be completed concurrently as exploratory endpoints to understand changes in the allergic immune response related to peanut SLIT.

Conditions

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Food Hypersensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

For the initial 12 months of the study, subjects were blinded to receive either peanut SLIT or placebo. After unblinding, subjects on placebo are crossed over to receive open-label peanut SLIT. They underwent an identical dosing protocol as those that were initially randomized to active treatment.

After 12 months of peanut SLIT dosing, whether initially randomized to active or crossed over from placebo, all subjects remained part of an open-label extended maintenance phase for the duration of the study (total peanut SLIT dosing 36-60 months)

2 additional cohorts were included in the protocol. One cohort, called the Early Unblinded Peanut SLIT cohort, was unblinded prior to the scheduled 12 month time point for pharmacy safety concerns. The second cohort, called the Pilot Peanut SLIT Rollover cohort involved subjects from the prior pilot study (NCT00429429) who were added to the study through an amendment and received open-label peanut SLIT.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Blinded Peanut SLIT

Blinded subjects who received peanut sublingual drops for the initial 12 month blinded phase of the study.

Group Type ACTIVE_COMPARATOR

Peanut SLIT

Intervention Type DRUG

Liquid peanut protein drops diluted in glycerin which are dosed under the tongue.

Blinded Placebo SLIT

Blinded subjects who received placebo sublingual drops for the initial 12 month blinded phase of the study.

Group Type PLACEBO_COMPARATOR

Placebo SLIT

Intervention Type DRUG

Liquid glycerin without peanut which are dosed under the tongue.

Ext. maint. open label peanut SLIT

After completing the blinded phase of the study, subjects receiving Blinded Peanut SLIT continued on extended maintenance open-label peanut SLIT for the duration of the study. Subjects receiving Blinded Placebo SLIT were crossed over and underwent the 12 month buildup protocol on open label peanut SLIT and then continued on extended maintenance treatment for the duration of the study.

Group Type OTHER

Peanut SLIT

Intervention Type DRUG

Liquid peanut protein drops diluted in glycerin which are dosed under the tongue.

Early unblinded peanut SLIT

Subjects who were unblinded prematurely during the blinded phase of the study and then re-enrolled as an open label cohort.

Group Type OTHER

Peanut SLIT

Intervention Type DRUG

Liquid peanut protein drops diluted in glycerin which are dosed under the tongue.

Pilot peanut SLIT rollover cohort

Subjects from the original phase 1 study of peanut SLIT (NCT00429429) who were rolled over into the current protocol as an open label peanut SLIT cohort.

Group Type OTHER

Peanut SLIT

Intervention Type DRUG

Liquid peanut protein drops diluted in glycerin which are dosed under the tongue.

Interventions

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Peanut SLIT

Liquid peanut protein drops diluted in glycerin which are dosed under the tongue.

Intervention Type DRUG

Placebo SLIT

Liquid glycerin without peanut which are dosed under the tongue.

Intervention Type DRUG

Other Intervention Names

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Sublingual peanut protein drops Sublingual glycerin saline drops

Eligibility Criteria

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Inclusion Criteria

* Peanut IgE \> 7kU/L (\> 2kU/L for children aged 2 years and under) AND
* History of significant clinical symptoms within 60 minutes after the ingestion of peanuts.

Exclusion Criteria

* History of severe life-threatening anaphylaxis to peanut, OR
* Medical history that would prevent a DBPCFC to peanut, OR
* Subjects with wheat or oat allergy (which are used in the placebo), OR
* Unable to cooperate with challenge procedures, OR
* Unable to be reached by telephone for follow-up

Minimum Eligible Age

1 Year

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No