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CompletedNCT00580606Updated Aug 21, 2019Results posted

A Randomized, Double-Blind Placebo-Controlled Peanut Sublingual Immunotherapy Trial

A Phase 1/2 interventional study of Glycerinated peanut allergenic extract and Placebo for peanut extract (glycerin) in Food Hypersensitivity, Hypersensitivity and Immediate Hypersensitivity, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 5 sites in United States. Open to participants aged 12 Years to 40 Years. Per ClinicalTrials.gov, last updated 2019-08-21.

Primary conditionPeanut HypersensitivityRegistry: Food HypersensitivityReclassifiedWhy we changed it
Registry
Food Hypersensitivity — the first condition term the registry derived for this study.
ClinicalTrials.gg
Peanut Hypersensitivity
Why
  1. The study's listed conditions name Peanut Hypersensitivity, a narrower term within Food Hypersensitivity.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
12 Years to 40 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the safety and immune response to daily sublingual (under the tongue) immunotherapy (SLIT) with peanut extract in adults and children with peanut allergies.

Read the detailed description

Peanut allergy is a common ailment in the United States. Research suggests that the prevalence of peanut allergy in the United States has doubled over the last 5 years. Currently, the only effective treatment for peanut allergy is a peanut-free diet and quick access to self-injectable epinephrine in the event of peanut exposure. The sublingual route is a potential method to administer immunotherapy for the treatment of food allergies. The intent of this study is to induce desensitization and eventually tolerance to peanut protein and evaluate the safety and immunologic effects of daily sublingual immunotherapy (SLIT) for individuals with peanut allergy. The trial will enroll 40 participants. After the first 10 participants between the ages of 18 and 40 are enrolled, safety information will be reviewed. If there are no safety concerns, the study will continue to enroll the remaining participants between the ages of 12 and 40.

This clinical trial will last 172 to 216 weeks. Participants will be randomly assigned to receive peanut SLIT or placebo SLIT. All participants will have an entry oral food challenge (OFC). The treatment group will receive gradual dosing escalations of peanut SLIT and maintenance therapy over a 44-week period, followed by another OFC. Following the OFC, participants will be unblinded, and the placebo group will receive peanut SLIT escalated to a higher maximum dose than the first treatment group. Maintenance therapy will continue for both groups for more than 2 years.

Study visits will occur every 2 weeks during dosing escalations of peanut SLIT, followed by visits gradually spacing out during maintenance to every 12 weeks. At selected visits, a physical examination, skin prick tests, blood and urine collection, and atopic dermatitis and asthma evaluations will occur. Approximately 6 OFCs will be administered to each participant throughout the course of the study. Additionally, 10 participants will be enrolled as control participants who will not receive any study therapy and will only have blood drawn at 3 visits throughout the course of the trial.

02

Conditions studied

  • Food Hypersensitivity
  • Hypersensitivity
  • Immediate Hypersensitivity
  • Peanut Hypersensitivity

Keywords

  • Food Allergy
  • Peanut Allergy
  • Sublingual Immunotherapy
03

In context

Peanut Hypersensitivity Reclassified

166 studies on the registry are indexed under Peanut Hypersensitivity; 27 are open to participants now.

This study's enrollment of 40 is below the median of 50 across 127 interventional studies indexed under Peanut Hypersensitivity.

Browse Peanut Hypersensitivity studies →

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.

Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.

Browse National Institute of Allergy and Infectious Diseases (NIAID) studies →

Compared within Peanut Hypersensitivity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Food Hypersensitivity. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
12 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Physician-diagnosed peanut allergy OR convincing clinical history of peanut allergy
  • Reacts to a cumulative dose of 2,000 mg or less of peanut powder
  • Positive peanut allergy skin prick test OR detectable serum peanut-specific IgE level
  • Willing to use an acceptable method of for the duration of the study
  • Ability to perform spirometry maneuver in accordance with the American Thoracic Society guidelines

Exclusion criteria

Exclusion Criteria:

  • History of severe anaphylaxis to peanut
  • Currently participating in a study using a new new drug
  • Participation in any interventional study for the treatment of food allergy in the 12 months prior to study entry
  • Allergic to placebo ingredients (glycerin or oat flour) OR reacts to any dose of placebo during study entry oral food challenge (OFC)
  • Currently in a buildup phase of any allergy immunotherapy
  • Poor control of atopic dermatitis
  • Moderate or severe asthma despite therapy
  • Current treatment with greater than medium daily doses of inhaled
  • Use of steroid medications
  • Use of omalizumab or other nontraditional forms of allergen immunomodulatory therapy (not including corticosteroids) or biologic therapy in the 12 months prior to study entry
  • Use of beta blockers, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, or calcium channel blockers
  • Inability to discontinue antihistamines for skin testing and OFCs
  • History of ischemic cardiovascular disease
  • History of alcohol or drug abuse
  • Other significant medical conditions that, in the opinion of the investigator, prevent participation in the study
  • Previous intubation due to allergies or asthma
  • Uncontrolled high blood pressure
  • Pregnancy or breastfeeding
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Low Dose Peanut SLIT (Double Blind to Open Label)

    Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for \>= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. Subjects who at the Week 116 OFC are unable to consume \>= 5,000 mg peanut powder or 10-fold the amount of peanut powder compared to the baseline OFC will discontinue study therapy. SLIT=Sublingual Immunotherapy.

    Drug: Glycerinated peanut allergenic extract

  • Placebo comparator
    Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)

    Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for \>= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over and receive open label high dose peanut SLIT; the study procedures and schedule are the same as for the Low Dose Peanut SLIT group, the only difference is the maximum maintenance dose is almost 3-fold higher at 3,696 mcg/day. DB=Double Blind, SLIT=Sublingual Immunotherapy, OL=Open Label.

    Drug: Placebo for peanut extract (glycerin)

Interventions

  • DrugGlycerinated peanut allergenic extract

    Glycerinated peanut extract delivered sublingually.

    Also known as: Peanut SLIT

  • DrugPlacebo for peanut extract (glycerin)

    Placebo (glycerin) delivered sublingually.

    Also known as: Placebo

06

What researchers measure

Primary outcomes

  1. Percent of Participants Who Successfully Consumed 5,000 mg of Peanut Powder or at Least a 10-fold Increase in the Amount of Peanut Powder Compared to Their Baseline Oral Food Challenge

    Desensitization Assessment: Participants who successfully consumed without dose-limiting symptoms 5,000 mg of peanut powder or at least a 10-fold increase in the amount of peanut powder compared to their baseline oral food challenge during a double-blind placebo-controlled oral food challenge were counted as successes.

    Time frame: Week 44 (Double Blind Period)

Secondary outcomes

  1. Percent of Participants Who Achieved a Maintenance Dose of 1,386 mcg

    During the build-up phase, escalation was to occur every 2 weeks until the 1,386 mcg maintenance dose was reached. The maximum time allowed for the build-up phase was 36 weeks; the dose achieved by 36 weeks was considered the maintenance dose.

    Time frame: Week 44 (Double Blind Period)

  2. Percent of Crossover Participants Who Successfully Consumed 5,000 mg of Peanut Powder or at Least a 10-fold Increase in the Amount of Peanut Powder Compared to Their Baseline Oral Food Challenge After 44 Weeks of Open Label Peanut Protein Consumption

    Desensitization Assessment: Participants who successfully consumed without dose-limiting symptoms 5,000 mg of peanut powder or at least a 10-fold increase in the amount of peanut powder compared to their baseline oral food challenge during a double-blind placebo-controlled oral food challenge were counted as successes.

    Time frame: Week 44 after initiating crossover open label peanut protein consumption

  3. Percent of Crossover Participants Who Achieved an Open Label Peanut Protein Consumption Maintenance Dose of 3,696 mcg

    During the build-up phase, escalation was to occur every 2 weeks until the 3,696 mcg maintenance dose was reached. The maximum time allowed for the build-up phase was 36 weeks; the dose achieved by 36 weeks was considered the maintenance dose.

    Time frame: Week 44 after initiating crossover open label peanut protein consumption

  4. Number of Participants With Serious Adverse Events (SAEs)

    This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.

    Time frame: Baseline through Week 44 (Double Blind Period)

  5. Number of Crossover Participants With Serious Adverse Events (SAEs) During 44 Weeks of Open Label Peanut Protein Consumption

    All subjects who were in the Placebo group during the double-blind phase of the study who initiated crossover peanut sublingual immunotherapy during the open label phase of the study will be included.

    Time frame: Initiation of open label peanut protein study therapy through Week 44 of open label peanut protein consumption

  6. Percent of Participants Who Successfully Consumed 10,000 mg of Peanut Powder

    Tolerance Assessment: Participants who successfully consumed without dose-limiting symptoms 10,000 mg of peanut powder during a double-blind placebo-controlled oral food challenge were then given an open feeding of peanut butter and those who successfully consumed the open feeding were counted as successes.

    Time frame: Approximately 8 weeks after discontinuing study therapy after 3 years on maintenance study therapy

07

Results

Posted Oct 30, 2012
Limitations and caveats
Refer to the original results published in the Journal of Allergy and Clinical Immunology, Vol 135, Number 5, page 1247 for a full description of the limitations of the current study.

Participant flow

Recruitment took place at five university-based medical centers in the United States (Mt. Sinai School of Medicine, Johns Hopkins University, Duke University, National Jewish Medical Center, University of Arkansas Children's Hospital from April 2008 to January 2010.

Double Blind (DB)
Participant flow — Double Blind (DB)
MilestoneLow Dose Peanut SLIT (Double Blind to Open Label)Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)
Started2020
Had week 44 oral food challenge1819
Completed2020
Not completed00
Open Label (OL)
Participant flow — Open Label (OL)
MilestoneLow Dose Peanut SLIT (Double Blind to Open Label)Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)
Started1817
Had week 44 oral food challenge012
Had week 68 oral food challenge1512
Had week 116 oral food challenge136
Had week 164 oral food challenge95
Had week 172 oral food challenge22
Completed95
Not completed912
Withdrew: Lack of efficacy at week 116 ofc21
Withdrew: Withdrawal by subject46
Withdrew: Dosing symptoms01
Withdrew: Lost to follow-up01
Withdrew: Pregnancy01
Withdrew: Non-compliance20
Withdrew: Physician decision11
Withdrew: Needed prohibited medication01

Outcome measures

PrimaryPercent of Participants Who Successfully Consumed 5,000 mg of Peanut Powder or at Least a 10-fold Increase in the Amount of Peanut Powder Compared to Their Baseline Oral Food Challenge

Desensitization Assessment: Participants who successfully consumed without dose-limiting symptoms 5,000 mg of peanut powder or at least a 10-fold increase in the amount of peanut powder compared to their baseline oral food challenge during a double-blind placebo-controlled oral food challenge were counted as successes.

Time frame:
Week 44 (Double Blind Period)
Reported as:
Number · Percentage of participants
Percent of Participants Who Successfully Consumed 5,000 mg of Peanut Powder or at Least a 10-fold Increase in the Amount of Peanut Powder Compared to Their Baseline Oral Food Challenge
Percentage of participantsLow Dose Peanut SLIT (Double Blind)Placebo (Double Blind)
Percent of Participants Who Successfully Consumed 5,000 mg of Peanut Powder or at Least a 10-fold Increase in the Amount of Peanut Powder Compared to Their Baseline Oral Food Challenge7015
Statistical analysis
  • Low Dose Peanut SLIT (Double Blind) vs Placebo (Double Blind) · Barnard's Statistic · p = <0.001 (No adjustments were made to the p-value.) · Risk difference (rd): 55 · 95% CI 22.2 to 77.6The a priori threshold for statistical significance is 0.05.
SecondaryPercent of Participants Who Achieved a Maintenance Dose of 1,386 mcg

During the build-up phase, escalation was to occur every 2 weeks until the 1,386 mcg maintenance dose was reached. The maximum time allowed for the build-up phase was 36 weeks; the dose achieved by 36 weeks was considered the maintenance dose.

Time frame:
Week 44 (Double Blind Period)
Reported as:
Number · Percentage of participants
Percent of Participants Who Achieved a Maintenance Dose of 1,386 mcg
Percentage of participantsLow Dose Peanut SLIT (Double Blind)Placebo (Double Blind)
Percent of Participants Who Achieved a Maintenance Dose of 1,386 mcg85.095.0
SecondaryPercent of Crossover Participants Who Successfully Consumed 5,000 mg of Peanut Powder or at Least a 10-fold Increase in the Amount of Peanut Powder Compared to Their Baseline Oral Food Challenge After 44 Weeks of Open Label Peanut Protein Consumption

Desensitization Assessment: Participants who successfully consumed without dose-limiting symptoms 5,000 mg of peanut powder or at least a 10-fold increase in the amount of peanut powder compared to their baseline oral food challenge during a double-blind placebo-controlled oral food challenge were counted as successes.

Time frame:
Week 44 after initiating crossover open label peanut protein consumption
Reported as:
Number · Percentage of participants
Percent of Crossover Participants Who Successfully Consumed 5,000 mg of Peanut Powder or at Least a 10-fold Increase in the Amount of Peanut Powder Compared to Their Baseline Oral Food Challenge After 44 Weeks of Open Label Peanut Protein Consumption
Percentage of participantsHigh Dose Peanut SLIT Crossover (Open Label)
Percent of Crossover Participants Who Successfully Consumed 5,000 mg of Peanut Powder or at Least a 10-fold Increase in the Amount of Peanut Powder Compared to Their Baseline Oral Food Challenge After 44 Weeks of Open Label Peanut Protein Consumption43.8
SecondaryPercent of Crossover Participants Who Achieved an Open Label Peanut Protein Consumption Maintenance Dose of 3,696 mcg

During the build-up phase, escalation was to occur every 2 weeks until the 3,696 mcg maintenance dose was reached. The maximum time allowed for the build-up phase was 36 weeks; the dose achieved by 36 weeks was considered the maintenance dose.

Time frame:
Week 44 after initiating crossover open label peanut protein consumption
Reported as:
Number · Percentage of participants
Percent of Crossover Participants Who Achieved an Open Label Peanut Protein Consumption Maintenance Dose of 3,696 mcg
Percentage of participantsHigh Dose Peanut SLIT Crossover (Open Label)
Percent of Crossover Participants Who Achieved an Open Label Peanut Protein Consumption Maintenance Dose of 3,696 mcg88.2
SecondaryNumber of Participants With Serious Adverse Events (SAEs)

This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.

Time frame:
Baseline through Week 44 (Double Blind Period)
Reported as:
Number · participants
Number of Participants With Serious Adverse Events (SAEs)
participantsLow Dose Peanut SLIT (Double Blind)Placebo (Double Blind)
Number of Participants With Serious Adverse Events (SAEs)10
SecondaryNumber of Crossover Participants With Serious Adverse Events (SAEs) During 44 Weeks of Open Label Peanut Protein Consumption

All subjects who were in the Placebo group during the double-blind phase of the study who initiated crossover peanut sublingual immunotherapy during the open label phase of the study will be included.

Time frame:
Initiation of open label peanut protein study therapy through Week 44 of open label peanut protein consumption
Reported as:
Number · participants
Number of Crossover Participants With Serious Adverse Events (SAEs) During 44 Weeks of Open Label Peanut Protein Consumption
participantsHigh Dose Peanut SLIT Crossover (Open Label)
Number of Crossover Participants With Serious Adverse Events (SAEs) During 44 Weeks of Open Label Peanut Protein Consumption0
SecondaryPercent of Participants Who Successfully Consumed 10,000 mg of Peanut Powder

Tolerance Assessment: Participants who successfully consumed without dose-limiting symptoms 10,000 mg of peanut powder during a double-blind placebo-controlled oral food challenge were then given an open feeding of peanut butter and those who successfully consumed the open feeding were counted as successes.

Time frame:
Approximately 8 weeks after discontinuing study therapy after 3 years on maintenance study therapy
Reported as:
Number · percentage of participants
Percent of Participants Who Successfully Consumed 10,000 mg of Peanut Powder
percentage of participantsLow Dose Peanut SLIT (Double Blind to Open Label)Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)
Percent of Participants Who Successfully Consumed 10,000 mg of Peanut Powder10.011.8

Adverse events

Collected over Baseline through 44 weeks of study therapy. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Low Dose Peanut SLIT Before Week 44 OFC (Double Blind)—1/20 (5%)19/20 (95%)
Placebo Before Week 44 OFC (Double Blind)—0/20 (0%)20/20 (100%)
High Dose Peanut SLIT Crossover Before Wk44 Crossover OFC (OL)—0/17 (0%)17/17 (100%)
Low Dose Peanut SLIT (Double Blind to Open Label)—1/18 (5.6%)17/18 (94.4%)
Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)—0/17 (0%)15/17 (88.2%)
Most frequent serious events
Most frequent serious events
EventLow Dose Peanut SLIT Before Week 44 OFC (Double Blind)Placebo Before Week 44 OFC (Double Blind)High Dose Peanut SLIT Crossover Before Wk44 Crossover OFC (OL)Low Dose Peanut SLIT (Double Blind to Open Label)Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)
Anaphylactic ReactionImmune system disorders0/200/200/171/180/17
UrticariaSkin and subcutaneous tissue disorders1/200/200/170/180/17
Most frequent other events
Showing 10 of 125
Most frequent other events
EventLow Dose Peanut SLIT Before Week 44 OFC (Double Blind)Placebo Before Week 44 OFC (Double Blind)High Dose Peanut SLIT Crossover Before Wk44 Crossover OFC (OL)Low Dose Peanut SLIT (Double Blind to Open Label)Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)
Oral disorderGastrointestinal disorders17/206/2016/1714/188/14
Oropharyngeal discomfortRespiratory, thoracic and mediastinal disorders9/203/206/173/181/14
Abdominal discomfortGastrointestinal disorders7/201/206/172/182/14
UrticariaSkin and subcutaneous tissue disorders7/201/206/175/183/14
PruritusSkin and subcutaneous tissue disorders7/203/202/171/182/14
NasopharyngitisInfections and infestations4/205/203/173/181/17
SinusitisInfections and infestations4/202/203/173/184/17
Upper respiratory tract congestionRespiratory, thoracic and mediastinal disorders0/201/204/170/180/17
SneezingRespiratory, thoracic and mediastinal disorders2/201/203/170/183/14
Upper respiratory tract infectionInfections and infestations4/204/203/173/183/17

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Low Dose Peanut SLIT (Double Blind to Open Label)Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)Total
<=18 years151530
Between 18 and 65 years5510
>=65 years000
Age, Continuous
Age, Continuous(years)Low Dose Peanut SLIT (Double Blind to Open Label)Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)Total
Mean17.2 ± 7.616.5 ± 3.516.8 ± 5.8
Sex: Female, Male
Sex: Female, Male(Participants)Low Dose Peanut SLIT (Double Blind to Open Label)Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)Total
Female7613
Male131427
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Low Dose Peanut SLIT (Double Blind to Open Label)Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)Total
Hispanic or Latino000
Not Hispanic or Latino202040
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Low Dose Peanut SLIT (Double Blind to Open Label)Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)Total
American Indian or Alaska Native000
Asian213
Native Hawaiian or Other Pacific Islander000
Black or African American101
White171936
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)Low Dose Peanut SLIT (Double Blind to Open Label)Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)Total
United States202040
Atopic Dermatitis Total Score
Atopic Dermatitis Total Score(Scores on a scale)Low Dose Peanut SLIT (Double Blind to Open Label)Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)Total
Mean1.1 ± 1.70.9 ± 1.61.0 ± 1.6
Total IgE
Total IgE(kU/L)Low Dose Peanut SLIT (Double Blind to Open Label)Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)Total
Mean407.8 ± 254.1330.5 ± 305.0369.1 ± 279.9

3 further baseline measures are reported on the registry.

08

Study locations

5 sites
  • University of Arkansas
    Little Rock, Arkansas 72202, United States
  • National Jewish Medical and Research Center
    Denver, Colorado 80208, United States
  • Johns Hopkins University School of Medicine
    Baltimore, Maryland 21218, United States
  • Mount Sinai School of Medicine
    New York, New York 10029, United States
  • University of North Carolina
    Durham, North Carolina 27706, United States
09

References and documents

Publications

  • de Leon MP, Rolland JM, O'Hehir RE. The peanut allergy epidemic: allergen molecular characterisation and prospects for specific therapy. Expert Rev Mol Med. 2007 Jan 9;9(1):1-18. doi: 10.1017/S1462399407000208. PubMed 17210088 ↗
  • Enrique E, Cistero-Bahima A. Specific immunotherapy for food allergy: basic principles and clinical aspects. Curr Opin Allergy Clin Immunol. 2006 Dec;6(6):466-9. doi: 10.1097/01.all.0000246618.41871.a4. PubMed 17088653 ↗
  • Sicherer SH, Sampson HA. Peanut allergy: emerging concepts and approaches for an apparent epidemic. J Allergy Clin Immunol. 2007 Sep;120(3):491-503; quiz 504-5. doi: 10.1016/j.jaci.2007.07.015. Epub 2007 Aug 8. PubMed 17689596 ↗
  • Fleischer DM, Burks AW, Vickery BP, Scurlock AM, Wood RA, Jones SM, Sicherer SH, Liu AH, Stablein D, Henning AK, Mayer L, Lindblad R, Plaut M, Sampson HA; Consortium of Food Allergy Research (CoFAR). Sublingual immunotherapy for peanut allergy: a randomized, double-blind, placebo-controlled multicenter trial. J Allergy Clin Immunol. 2013 Jan;131(1):119-27.e1-7. doi: 10.1016/j.jaci.2012.11.011. PubMed 23265698 ↗
  • Burks AW, Wood RA, Jones SM, Sicherer SH, Fleischer DM, Scurlock AM, Vickery BP, Liu AH, Henning AK, Lindblad R, Dawson P, Plaut M, Sampson HA; Consortium of Food Allergy Research. Sublingual immunotherapy for peanut allergy: Long-term follow-up of a randomized multicenter trial. J Allergy Clin Immunol. 2015 May;135(5):1240-8.e1-3. doi: 10.1016/j.jaci.2014.12.1917. Epub 2015 Feb 3. PubMed 25656999 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00580606
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Consortium of Food Allergy Research
Responsible party
Sponsor
First posted
Dec 25, 2007
Start date
Dec 2007
Primary completion
Dec 2010
Completion
Dec 2014
Results posted
Oct 30, 2012
Last update
Aug 21, 2019

Study contacts

Wesley Burks, MD
study chair · Duke University
David Fleischer, MD
study chair · National Jewish Health
Hugh A. Sampson, MD
principal investigator · Icahn School of Medicine at Mount Sinai
Stacie Jones, MD
principal investigator · Arkansas Children's Hospital Research Institute
Robert Wood, MD
principal investigator · Johns Hopkins University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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