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Completed

NCT Number: NCT00597727

A Study of Sublingual Immunotherapy in Peanut-allergic Children

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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Key information

Conditions

Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nut and Peanut Hypersensitivity Peanut Hypersensitivity

Age range

1 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peanut SLIT

Drug

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

Other names: Sublingual peanut protein drops

Placebo SLIT

Drug

Liquid glycerin without peanut which are dosed under the tongue.

Other names: Sublingual glycerin saline drops

Primary outcomes

  1. Percentage of Subjects Who Can Tolerate the Peanut Oral Food Challenge After 12 Months of Peanut SLIT Dosing

    Time frame: 12 months

    Upon completion of 12 months of peanut SLIT treatment, subjects underwent a double-blind placebo controlled food challenge (DBPCFC) to assess desensitization (an increase in reaction threshold while on therapy). A DBPCFC involves the ingestion of small increasing amounts of peanut up to a cumulative total amount. The primary clinical efficacy outcome of the study was the percentage of peanut allergic subjects who completed a 2500 mg peanut protein DBPCFC without developing symptoms after 12 months of peanut SLIT therapy.

Secondary outcomes

  1. Percentage of Subjects Tolerating a Peanut Oral Food Challenge 2-4 Weeks After Discontining Peanut SLIT Dosing

    Time frame: 36-60 months

    Upon completion of 36-60 months of peanut SLIT treatment, subjects underwent a double-blind placebo controlled food challenge (DBPCFC) to assess desensitization (an increase in reaction threshold while on therapy). A DBPCFC involves the ingestion of small increasing amounts of peanut up to a cumulative total amount. Peanut SLIT therapy was then discontinued for 2-4 weeks to assess for persistence of the desensitization response called sustained unresponsiveness (SU). The secondary clinical efficacy outcome of the study was the percentage of peanut allergic subjects who completed a 5000 mg peanut protein DBPCFC without developing symptoms 2-4 weeks after discontinuing peanut SLIT therapy.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

A Double-blinded, Placebo-controlled Study of Peanut Sublingual Immunotherapy in Children - DBPC Peanut SLIT

Acronym: SLB

Important dates

Study start
2008
Primary completion
2016
Study completion
2016
First posted
Jan 18, 2008
Registry last updated
Mar 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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