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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01AT004435-09 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blinded Peanut SLIT | Active Comparator | Blinded subjects who received peanut sublingual drops for the initial 12 month blinded phase of the study. |
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| Blinded Placebo SLIT | Placebo Comparator | Blinded subjects who received placebo sublingual drops for the initial 12 month blinded phase of the study. |
|
| Ext. maint. open label peanut SLIT | Other | 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. |
|
| Early unblinded peanut SLIT | Other | Subjects who were unblinded prematurely during the blinded phase of the study and then re-enrolled as an open label cohort. |
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| Pilot peanut SLIT rollover cohort | Other | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peanut SLIT | Drug | Liquid peanut protein drops diluted in glycerin which are dosed under the tongue. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Who Can Tolerate the Peanut Oral Food Challenge After 12 Months of Peanut SLIT Dosing | 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Tolerating a Peanut Oral Food Challenge 2-4 Weeks After Discontining Peanut SLIT Dosing | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wesley Burks, MD | University of North Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23534975 | Background | Chin SJ, Vickery BP, Kulis MD, Kim EH, Varshney P, Steele P, Kamilaris J, Hiegel AM, Carlisle SK, Smith PB, Scurlock AM, Jones SM, Burks AW. Sublingual versus oral immunotherapy for peanut-allergic children: a retrospective comparison. J Allergy Clin Immunol. 2013 Aug;132(2):476-8.e2. doi: 10.1016/j.jaci.2013.02.017. Epub 2013 Mar 25. No abstract available. | |
| 21281959 | Result | Kim EH, Bird JA, Kulis M, Laubach S, Pons L, Shreffler W, Steele P, Kamilaris J, Vickery B, Burks AW. Sublingual immunotherapy for peanut allergy: clinical and immunologic evidence of desensitization. J Allergy Clin Immunol. 2011 Mar;127(3):640-6.e1. doi: 10.1016/j.jaci.2010.12.1083. Epub 2011 Feb 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Blinded Peanut SLIT | Blinded subjects who received peanut sublingual drops for the initial 12 month blinded phase of the study. |
| FG001 | Blinded Placebo SLIT | Blinded subjects who received placebo sublingual drops for the initial 12 month blinded phase of the study. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 12 Month Blinded Phase |
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| Open-label Extended Maintenance Phase |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Blinded Peanut SLIT | Blinded subjects who received peanut sublingual drops) at the beginning of the study. |
| BG001 | Blinded Placebo SLIT | Blinded subjects who receive placebo (glycerin sublingual drops) at the beginning of the study. Placebo SLIT: Liquid glycerin without peanut which are dosed under the tongue. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Percentage of Subjects Who Can Tolerate the Peanut Oral Food Challenge After 12 Months of Peanut SLIT Dosing | 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. | Interim analysis in 7/2010 showed statistically significant difference in peanut tolerated during oral food challenge (OFC) by active treatment vs placebo (1710mg vs 85mg). Further OFCs for those on placebo was considered more risk than benefit thus were discontinued resulting in subsequent patients being unblinded after 12 months without an OFC | Posted | Number | percentage of participants | 12 months |
|
AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.
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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 | Blinded Peanut SLIT | Blinded subjects who received peanut sublingual drops for the initial 12 month blinded phase of the study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
The initial 27 subjects in the study were unblinded in 12/2009 due to concerns for study drug integrity. These subjects were offered reentry into the study on open label drug. 18 accepted and are presented as the Early Unblinded Peanut SLIT cohort.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Edwin Kim, Director 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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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.
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|
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| Placebo SLIT | Drug | Liquid glycerin without peanut which are dosed under the tongue. |
|
|
| 36-60 months |
| 22236732 | Result | Kulis M, Saba K, Kim EH, Bird JA, Kamilaris N, Vickery BP, Staats H, Burks AW. Increased peanut-specific IgA levels in saliva correlate with food challenge outcomes after peanut sublingual immunotherapy. J Allergy Clin Immunol. 2012 Apr;129(4):1159-62. doi: 10.1016/j.jaci.2011.11.045. Epub 2012 Jan 10. |
| COMPLETED |
|
| NOT COMPLETED |
|
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 |
| Blinded Peanut SLIT |
Blinded subjects who received peanut sublingual drops for the initial 12 month blinded phase of the study. |
| OG001 | Blinded Placebo SLIT | Blinded subjects who received placebo sublingual drops for the initial 12 month blinded phase of the study. |
| OG002 | 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. |
| OG003 | 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. |
|
|
| Secondary | Percentage of Subjects Tolerating a Peanut Oral Food Challenge 2-4 Weeks After Discontining Peanut SLIT Dosing | 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. | Although the 12 month OFC was discontinued beginning in 7/2010, all subjects reaching the end of study (36-60 months of treatment) underwent an OFC resulting in more patients performing the end of study OFC than the 12 month OFC. | Posted | Number | percentage of participants | 36-60 months |
|
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|
| 0 |
| 14 |
| 0 |
| 14 |
| 10 |
| 14 |
| EG001 | Blinded Placebo SLIT | Blinded subjects who received placebo sublingual drops for the initial 12 month blinded phase of the study. | 0 | 15 | 0 | 15 | 12 | 15 |
| EG002 | 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. | 0 | 29 | 0 | 29 | 21 | 29 |
| EG003 | 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. | 0 | 27 | 0 | 27 | 19 | 27 |
| EG004 | 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. | 0 | 4 | 0 | 4 | 3 | 4 |
| 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 | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Sneezing | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Coughing | 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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