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| Name | Class |
|---|---|
| University of Arkansas | OTHER |
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The purpose of this study is to determine if mucosal peanut immunotherapy will make subjects who have peanut allergy less allergic and induce changes in their immune system.
Peanut allergy is known to cause severe anaphylactic reactions. Compared with other food allergies it tends to be more persistent and also its prevalence seems to be rising. Currently there is no proven treatment other than strict avoidance. We are attempting to decrease the risk of anaphylaxis on accidental ingestion by desensitizing subjects to peanut using peanut oral mucosal immunotherapy (OIT). We are also studying the effect of peanut OIT on the peanut specific immune response to determine if tolerance to peanut protein will develop. Children ages 1 to 18 with peanut allergy will be randomized to peanut OIT or placebo. Subjects will undergo a modified rush immunotherapy on the first day and then increase the doses at least every two weeks up to a maintenance dose of 4 grams (equivalent to about 13 peanuts). Doses will be taken daily at home except for dose increases which will be done on the research unit. Subjects will undergo a double-blind, placebo-controlled food challenge (DBPCFC) after 12 months and then be unblinded. Placebo subjects will cross over to open-label peanut OIT and undergo an identical buildup schedule up to 12 months. All subjects will then complete at least 36 months of peanut OIT therapy after which once skin prick (<5 mm) and IgE (<15 kU/L) criteria are met, they will then complete the end of study DBPCFC. Dosing will continue up to a maximum of 60 months after which even if criteria are not met, the subject will undergo the end of study DBPCFC. Outcome variables of interest include response to DBPCFC, skin prick testing, peanut specific IgE, and adverse events. These results will be compared between the start and end of peanut OIT using appropriate statistical analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Oat flour ingested daily as a placebo |
|
| Peanut OIT | Active Comparator | Peanut flour ingested daily as oral mucosal immunotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peanut OIT | Biological | Defatted peanut flour ingested daily as oral mucosal immunotherapy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The Amount of Peanut Protein Ingested Before An Allergic Reaction is Observed During the Double-blind, Placebo Controlled Food Challenge (DBPCFC) After Completing Treatment With Peanut OIT. | After completing the peanut OIT protocol (defined as treatment with peanut OIT for at least 36-months AND a peanut-specific IgE >2 and <15 AND skin prick test is <5 mm OR a maximum of 60 months of treatment), the reaction threshold for subjects is assessed by a DBPCFC. This involves eating small increasing doses of peanut protein in a blinded fashion up to a cumulative total of 5000 mg. An identical food challenge is also performed with oat flour as a placebo. The cumulative amount of peanut protein ingested prior to the dose that causes a reaction requiring treatment is reported as the reaction threshold. | 36-60 months |
| Measure | Description | Time Frame |
|---|---|---|
| The Amount of Peanut Protein Ingested Before An Allergic Reaction is Observed During the Double-blind, Placebo Controlled Food Challenge (DBPCFC) After Completing 12 Months of Blinded Peanut OIT or Placebo Treatment. | After 12 months of blinded Peanut OIT treatment, the reaction threshold for subjects is assessed by a DBPCFC. This involves eating small increasing doses of peanut protein in a blinded fashion up to a cumulative total of 4710 mg. An identical food challenge is also performed with oat flour as a placebo. The cumulative amount of peanut protein ingested prior to the dose that causes a reaction requiring treatment is reported as the reaction threshold. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arvil W Burks, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas Medical Center | Little Rock | Arkansas | 72202 | United States | ||
| University of North Carolina |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Oat flour taken daily as a placebo |
| FG001 | Peanut OIT | Peanut flour ingested daily as active OIT treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Blinded Phase |
| |||||||||||||
| Open Label Phase |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Oat flour taken daily as a placebo |
| BG001 | Peanut OIT | Peanut flour ingested daily as active OIT treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Amount of Peanut Protein Ingested Before An Allergic Reaction is Observed During the Double-blind, Placebo Controlled Food Challenge (DBPCFC) After Completing Treatment With Peanut OIT. | After completing the peanut OIT protocol (defined as treatment with peanut OIT for at least 36-months AND a peanut-specific IgE >2 and <15 AND skin prick test is <5 mm OR a maximum of 60 months of treatment), the reaction threshold for subjects is assessed by a DBPCFC. This involves eating small increasing doses of peanut protein in a blinded fashion up to a cumulative total of 5000 mg. An identical food challenge is also performed with oat flour as a placebo. The cumulative amount of peanut protein ingested prior to the dose that causes a reaction requiring treatment is reported as the reaction threshold. | Posted | Median | Full Range | mg of peanut protein | 36-60 months |
|
During the initial 12 months of the study, subjects were blinded and adverse events were reported separately for treatment and placebo groups. During the open label phase of treatment, adverse events were reported for the entire cohort. For subjects on active therapy, open-label was from after unblinding at 12 months through 36-60 months. For subjects on placebo, open-label was from crossing over to peanut OIT at time 0 through 36-60 months of active treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Open Label Phase-Peanut OIT | All subjects receiving open-label peanut OIT from the point of unblinding through the end of the treatment phase. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Edwin Kim, Director of the UNC Food Allergy Initiative | University of North Carolina at Chapel Hill | 919-843-9087 | edwinkim@email.unc.edu |
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| ID | Term |
|---|---|
| D005512 | Food Hypersensitivity |
| D021183 | Peanut Hypersensitivity |
| ID | Term |
|---|---|
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000074924 | Nut and Peanut Hypersensitivity |
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| Placebo |
| Biological |
Oat flour matched by weight and consistency that is ingested daily as a placebo |
|
| 12 months |
| The Change From Baseline Through the End of Peanut OIT Treatment in Wheal Size Diameter Following Peanut Skin Prick Testing | Skin prick testing is performed by scratching the skin with a small amount of peanut and observing for redness and a raised bump called a wheal. The diameter of the wheal is measured with a ruler in mm and recorded as a measure of peanut-specific IgE and mast cell reactivity in an allergic subject. A decrease in wheal size after treatment would represent suppression of the allergic response. | Baseline to end of open label phase treatment (36-60 months) |
| The Change From Baseline Through the End of Peanut OIT Treatment in Peanut-specific IgE in the Blood | Peanut specific IgE on the surface of mast cells and basophils releases histamine when exposed to peanut causing symptoms of allergy. Free-floating peanut-specific IgE is measured from serum in the blood by an immunoCAP machine and reported in kU/L. A lower level of peanut-specific IgE could suggest a decrease in the probability of reaction for a subject who is exposed to peanut. | Baseline to end of open label phase treatment (36-60 months) |
| The Change From Baseline Through the End of Peanut OIT Treatment in Peanut-specific IgG4 in the Blood. | Peanut specific IgG4 is thought to have a protective effect for a subject when exposed to peanut possibly by interfering with IgE. Peanut-specific IgG4 is measured from serum in the blood by an immunoCAP machine and reported in mg/dL. A higher level of peanut-specific IgG4 could suggest a decrease in the probability of reaction for a subject who is exposed to peanut. | Baseline to end of open label phase treatment (36-60 months) |
| Chapel Hill |
| North Carolina |
| 27599 |
| United States |
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|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
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| Secondary | The Amount of Peanut Protein Ingested Before An Allergic Reaction is Observed During the Double-blind, Placebo Controlled Food Challenge (DBPCFC) After Completing 12 Months of Blinded Peanut OIT or Placebo Treatment. | After 12 months of blinded Peanut OIT treatment, the reaction threshold for subjects is assessed by a DBPCFC. This involves eating small increasing doses of peanut protein in a blinded fashion up to a cumulative total of 4710 mg. An identical food challenge is also performed with oat flour as a placebo. The cumulative amount of peanut protein ingested prior to the dose that causes a reaction requiring treatment is reported as the reaction threshold. | Posted | Median | Full Range | mg of peanut protein | 12 months |
|
|
|
| Secondary | The Change From Baseline Through the End of Peanut OIT Treatment in Wheal Size Diameter Following Peanut Skin Prick Testing | Skin prick testing is performed by scratching the skin with a small amount of peanut and observing for redness and a raised bump called a wheal. The diameter of the wheal is measured with a ruler in mm and recorded as a measure of peanut-specific IgE and mast cell reactivity in an allergic subject. A decrease in wheal size after treatment would represent suppression of the allergic response. | Posted | Median | Full Range | mm | Baseline to end of open label phase treatment (36-60 months) |
|
|
|
| Secondary | The Change From Baseline Through the End of Peanut OIT Treatment in Peanut-specific IgE in the Blood | Peanut specific IgE on the surface of mast cells and basophils releases histamine when exposed to peanut causing symptoms of allergy. Free-floating peanut-specific IgE is measured from serum in the blood by an immunoCAP machine and reported in kU/L. A lower level of peanut-specific IgE could suggest a decrease in the probability of reaction for a subject who is exposed to peanut. | Posted | Median | Full Range | kU/L | Baseline to end of open label phase treatment (36-60 months) |
|
|
|
| Secondary | The Change From Baseline Through the End of Peanut OIT Treatment in Peanut-specific IgG4 in the Blood. | Peanut specific IgG4 is thought to have a protective effect for a subject when exposed to peanut possibly by interfering with IgE. Peanut-specific IgG4 is measured from serum in the blood by an immunoCAP machine and reported in mg/dL. A higher level of peanut-specific IgG4 could suggest a decrease in the probability of reaction for a subject who is exposed to peanut. | Posted | Median | Full Range | mg/dL | Baseline to end of open label phase treatment (36-60 months) |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 6 |
| 9 |
| EG001 | Blinded Phase-Placebo | Patients receiving oat flour as a placebo during the initial 12 months of therapy. | 0 | 4 | 0 | 4 | 4 | 4 |
| EG002 | Blinded Phase-Peanut OIT | Patients receiving peanut flour as active OIT during the initial 12 months of therapy. | 0 | 6 | 0 | 6 | 6 | 6 |
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Erythematous rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Wheezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Oropharyngeal itching | Gastrointestinal disorders | Systematic Assessment |
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| Sneezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Itchy nose | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Skin itch | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Lip or eye swelling | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Eye itch | Eye disorders | Systematic Assessment |
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| Eye tearing | Eye disorders | Systematic Assessment |
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| Hives | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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