Peanut Oral Immunotherapy in Children (IMPACT)
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| ClinicalTrials.gov Identifier: NCT01867671 |
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Recruitment Status :
Completed
First Posted : June 4, 2013
Results First Posted : January 22, 2020
Last Update Posted : March 16, 2020
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment |
| Condition |
Peanut Hypersensitivity |
| Interventions |
Biological: Peanut Oral Immunotherapy - Liquid Extract Biological: Placebo for Peanut Oral Immunotherapy - Liquid Extract form Biological: Peanut Oral Immunotherapy - Peanut Flour Biological: Placebo for Peanut Oral Immunotherapy - Peanut Flour |
| Enrollment | 146 |
| Recruitment Details | Participants ages 1 to 3 with a clinical history of peanut allergy or avoidance of peanut without ever having eaten peanut were recruited from 5 clinical centers in the United States from August 2013 to October 2015. |
| Pre-assignment Details | Individuals with a history of severe anaphylaxis (previous hypotension) to peanut were excluded. |
| Arm/Group Title | Peanut Oral Immune Therapy (OIT) | Peanut Placebo |
|---|---|---|
 Arm/Group Description |
Peanut Oral Immune Therapy (OIT) for 134 weeks followed by peanut avoidance for 26 weeks. Two forms of peanut oral immunotherapy were used. One form was a liquid extract derived from the peanut flour source material. This was used during initial dose escalation for doses 0.1 to 0.8 mg of peanut protein. The second form was peanut flour, which was used for the remainder of dose escalation, build-up, and maintenance. |
Peanut placebo for 134 weeks followed by peanut avoidance for 26 weeks. Two forms of placebo were used. One form was a liquid extract derived from oat flour source material. This was used during initial dose escalation for doses 0.1 to 0.8 mg. The second form was peanut flour, which was used for the remainder of dose escalation, build-up, and maintenance. |
| Period Title: Overall Study | ||
| Started | 96 | 50 |
| Completed | 67 | 22 |
| Not Completed | 29 | 28 |
| Reason Not Completed | ||
| Adverse Event | 5 | 3 |
| Anaphylaxis | 0 | 1 |
| Inability to reach 3 mg peanut/placebo | 2 | 0 |
| Lost to Follow-up | 0 | 1 |
| Non-compliance with Study Drug | 1 | 2 |
| Withdrawal by Subject | 21 | 21 |
| Arm/Group Title | Peanut Oral Immune Therapy (OIT) | Peanut Placebo | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Peanut Oral Immune Therapy (OIT) for 134 weeks followed by peanut avoidance for 26 weeks. Two forms of peanut oral immunotherapy were used. One form was a liquid extract derived from the peanut flour source material. This was used during initial dose escalation for doses 0.1 to 0.8 mg of peanut protein. The second form was peanut flour, which was used for the remainder of dose escalation, build-up, and maintenance. |
Peanut placebo for 134 weeks followed by peanut avoidance for 26 weeks. Two forms of placebo were used. One form was a liquid extract derived from oat flour source material. This was used during initial dose escalation for doses 0.1 to 0.8 mg. The second form was peanut flour, which was used for the remainder of dose escalation, build-up, and maintenance. |
Total of all reporting groups | |
| Overall Number of Baseline Participants | 96 | 50 | 146 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 96 participants | 50 participants | 146 participants | |
| 3.1 (0.7) | 3.0 (0.8) | 3.1 (0.8) | ||
|
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||
| Number Analyzed | 96 participants | 50 participants | 146 participants | |
| Female |
30 31.3%
|
18 36.0%
|
48 32.9%
|
|
| Male |
66 68.8%
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32 64.0%
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98 67.1%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 96 participants | 50 participants | 146 participants | |
| Hispanic or Latino |
3 3.1%
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3 6.0%
|
6 4.1%
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|
| Not Hispanic or Latino |
92 95.8%
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45 90.0%
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137 93.8%
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|
| Unknown or Not Reported |
1 1.0%
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2 4.0%
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3 2.1%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 96 participants | 50 participants | 146 participants | |
| American Indian or Alaska Native |
0 0.0%
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0 0.0%
|
0 0.0%
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| Asian |
15 15.6%
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3 6.0%
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18 12.3%
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|
| Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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| Black or African American |
1 1.0%
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5 10.0%
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6 4.1%
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| White |
64 66.7%
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31 62.0%
|
95 65.1%
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| More than one race |
16 16.7%
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11 22.0%
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27 18.5%
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|
| Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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| United States | Number Analyzed | 96 participants | 50 participants | 146 participants |
| 96 | 50 | 146 | ||
| Name/Title: | Director, Clinical Research Operations Program |
| Organization: | DAIT/NIAID |
| Phone: | 301-594-7669 |
| EMail: | DAITClinicalTrialsGov@niaid.nih.gov |
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT01867671 |
| Other Study ID Numbers: |
DAIT ITN050AD |
| First Submitted: | May 23, 2013 |
| First Posted: | June 4, 2013 |
| Results First Submitted: | December 20, 2019 |
| Results First Posted: | January 22, 2020 |
| Last Update Posted: | March 16, 2020 |