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A Study of Sublingual Immunotherapy in Peanut-allergic Children (SLB)

This study has been completed.
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Wesley Burks, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00597727
First received: January 7, 2008
Last updated: April 7, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention Phase
Food Hypersensitivity
Drug: Peanut SLIT
Drug: Placebo SLIT
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

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.

Masking: Participant, Care Provider, Investigator
Primary Purpose: Treatment
Official Title: A Double-blinded, Placebo-controlled Study of Peanut Sublingual Immunotherapy in Children - DBPC Peanut SLIT

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.


Enrollment: 60
Study Start Date: January 2008
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Blinded Peanut SLIT
Blinded subjects who received peanut sublingual drops for the initial 12 month blinded phase of the study.
Drug: Peanut SLIT
Liquid peanut protein drops diluted in glycerin which are dosed under the tongue.
Other Name: Sublingual peanut protein drops
Placebo Comparator: Blinded Placebo SLIT
Blinded subjects who received placebo sublingual drops for the initial 12 month blinded phase of the study.
Drug: Placebo SLIT
Liquid glycerin without peanut which are dosed under the tongue.
Other Name: Sublingual glycerin saline drops
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.
Drug: Peanut SLIT
Liquid peanut protein drops diluted in glycerin which are dosed under the tongue.
Other Name: Sublingual peanut protein drops
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.
Drug: Peanut SLIT
Liquid peanut protein drops diluted in glycerin which are dosed under the tongue.
Other Name: Sublingual peanut protein drops
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.
Drug: Peanut SLIT
Liquid peanut protein drops diluted in glycerin which are dosed under the tongue.
Other Name: Sublingual peanut protein drops

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   1 Year to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00597727

Locations
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Wesley Burks, MD University of North Carolina
  More Information

Publications:
Responsible Party: Wesley Burks, MD, Chairman, Department of Pediatrics, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00597727     History of Changes
Other Study ID Numbers: 11-2296
5R01AT004435-09 ( US NIH Grant/Contract Award Number )
Study First Received: January 7, 2008
Results First Received: February 7, 2017
Last Updated: April 7, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University of North Carolina, Chapel Hill:
Peanut Allergy
Sublingual immunotherapy

Additional relevant MeSH terms:
Hypersensitivity
Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate
Glycerol
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 25, 2017