Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Peanut Oral Immunotherapy in Children (IMPACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01867671
Recruitment Status : Completed
First Posted : June 4, 2013
Results First Posted : January 22, 2020
Last Update Posted : March 16, 2020
Sponsor:
Collaborator:
Immune Tolerance Network (ITN)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

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
Hide 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
Hide 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
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
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%
32
  64.0%
98
  67.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 96 participants 50 participants 146 participants
Hispanic or Latino
3
   3.1%
3
   6.0%
6
   4.1%
Not Hispanic or Latino
92
  95.8%
45
  90.0%
137
  93.8%
Unknown or Not Reported
1
   1.0%
2
   4.0%
3
   2.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 96 participants 50 participants 146 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
15
  15.6%
3
   6.0%
18
  12.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   1.0%
5
  10.0%
6
   4.1%
White
64
  66.7%
31
  62.0%
95
  65.1%
More than one race
16
  16.7%
11
  22.0%
27
  18.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 96 participants 50 participants 146 participants
96 50 146
1.Primary Outcome
Title Percentage of Participants Desensitized to Peanut Protein After 134 Weeks of Oral Immunotherapy (OIT)
Hide Description

Definition of desensitized to peanut: A participant who passed the blinded (masked) oral food challenge (OFC) to10 grams of peanut flour (=5 grams of peanut protein) without significant symptoms.*

*Significant symptoms include hives, wheezing, vomiting, or laryngeal edema.

Time Frame Week 134
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peanut Oral Immune Therapy (OIT) Peanut Placebo
Hide 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.

Overall Number of Participants Analyzed 96 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
71
(61.7 to 79.9)
2
(0.0 to 5.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Peanut Oral Immune Therapy (OIT), Peanut Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 205.45
Confidence Interval (2-Sided) 95%
24.00 to 1758.51
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Tolerant Participants at Week 160
Hide Description Definition of Tolerant: A participant who passed the oral food challenge (OFC) to 10 grams of peanut flour (=5 grams of peanut protein).
Time Frame Week 160
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peanut Oral Immune Therapy (OIT) Peanut Placebo
Hide 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.

Overall Number of Participants Analyzed 96 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
21
(12.7 to 29.0)
2
(0.0 to 5.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Peanut Oral Immune Therapy (OIT), Peanut Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0031
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 27.82
Confidence Interval (2-Sided) 95%
3.07 to 252.33
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Count of Participants With Transient Desensitization
Hide Description Definition of transient desensitization: A participant who passed the blinded (masked) oral food challenge (OFC) to 10 grams peanut flour (=5 grams peanut protein) at week 134 and failed the week 160 in the Peanut oral immunotherapy (OIT) group.
Time Frame Week 134, Week 160
Hide Outcome Measure Data
Hide Analysis Population Description
Participants randomized to the Peanut Oral Immunotherapy (OIT) group
Arm/Group Title Peanut Oral Immune Therapy (OIT)
Hide 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.

Overall Number of Participants Analyzed 96
Measure Type: Count of Participants
Unit of Measure: Participants
Passed Week 134 and Failed Week 160
49
  51.0%
Passed Week 134 and Passed Week 160
19
  19.8%
Failed Week 134 and Failed Week 160
27
  28.1%
Failed Week 134 and Passed Week 160
1
   1.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Peanut Oral Immune Therapy (OIT)
Comments [Not Specified]
Type of Statistical Test Other
Comments McNemar's Test
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
Method of Estimation Estimation Parameter Simple Kappa Coefficient
Estimated Value 0.1620
Confidence Interval (2-Sided) 95%
0.0628 to 0.2612
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Highest Tolerated Cumulative Dose
Hide Description

The highest tolerated cumulative dose of peanut protein during the blinded (masked) oral food challenge (OFC) at Week 160, analyzed within and between both placebo and peanut OIT groups. The highest cumulative dose of peanut protein tolerated for each participant was analyzed as a continuous outcome.

Any randomized participant without an evaluable blinded (masked) OFC was imputed as not tolerant. For the continuous highest cumulative dose endpoint, this is defined as having a highest cumulative dose imputed as zero.

Time Frame Week 160
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peanut Oral Immune Therapy (OIT) Peanut Placebo
Hide 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.

Overall Number of Participants Analyzed 96 50
Mean (95% Confidence Interval)
Unit of Measure: mg protein
1645
(1338 to 1951)
180
(-244 to 605)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Peanut Oral Immune Therapy (OIT), Peanut Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1464
Confidence Interval (2-Sided) 95%
944 to 1985
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants That Withdrew From the Study
Hide Description Percentage of participants that withdrew from study participation, listed by study phase (at time of study withdrawal).
Time Frame Initial Dose Escalation through Week 160 (Tolerance Assessment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peanut Oral Immune Therapy (OIT) Peanut Placebo
Hide 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.

Overall Number of Participants Analyzed 96 50
Measure Type: Number
Unit of Measure: percentage of participants
Terminated during Initial Dose Escalation 2 0
Terminated during Build-Up 4 12
Terminated during Maintenance 8 16
Terminated after Maintenance/Prior to OFC 1 2
Terminated during Avoidance 11 14
Terminated after Avoidance/Prior to OFC 0 10
Terminated after Tolerance Assessment 3 2
Time Frame 162 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Peanut Oral Immunotherapy (OIT) Peanut Placebo
Hide Arm/Group Description Peanut OIT for 134 weeks followed by peanut avoidance for 26 weeks. Peanut placebo for 134 weeks followed by peanut avoidance for 26 weeks. The placebo extract was derived from oat flour source material.
All-Cause Mortality
Peanut Oral Immunotherapy (OIT) Peanut Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/96 (0.00%)      0/50 (0.00%)    
Hide Serious Adverse Events
Peanut Oral Immunotherapy (OIT) Peanut Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/96 (3.13%)      4/50 (8.00%)    
Gastrointestinal disorders     
Vomiting  1  0/96 (0.00%)  0 2/50 (4.00%)  2
Immune system disorders     
Anaphylactic reaction  1  0/96 (0.00%)  0 1/50 (2.00%)  1
Infections and infestations     
Pyelonephritis  1  1/96 (1.04%)  1 0/50 (0.00%)  0
Respiratory tract infection  1  1/96 (1.04%)  1 0/50 (0.00%)  0
Injury, poisoning and procedural complications     
Vaccination complication  1  0/96 (0.00%)  0 1/50 (2.00%)  1
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/96 (1.04%)  1 1/50 (2.00%)  1
1
Term from vocabulary, MedDRA V16.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Peanut Oral Immunotherapy (OIT) Peanut Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   96/96 (100.00%)      50/50 (100.00%)    
Ear and labyrinth disorders     
Ear pain  1  4/96 (4.17%)  9 3/50 (6.00%)  3
Eye disorders     
Conjunctivitis  1  6/96 (6.25%)  8 5/50 (10.00%)  9
Gastrointestinal disorders     
Abdominal discomfort  1  18/96 (18.75%)  48 4/50 (8.00%)  6
Abdominal pain  1  29/96 (30.21%)  105 5/50 (10.00%)  18
Abdominal pain upper  1  10/96 (10.42%)  26 2/50 (4.00%)  4
Constipation  1  8/96 (8.33%)  8 7/50 (14.00%)  8
Diarrhoea  1  20/96 (20.83%)  26 12/50 (24.00%)  20
Gastritis  1  13/96 (13.54%)  19 5/50 (10.00%)  15
Lip pruritus  1  5/96 (5.21%)  10 0/50 (0.00%)  0
Vomiting  1  45/96 (46.88%)  80 19/50 (38.00%)  32
General disorders     
Influenza like illness  1  20/96 (20.83%)  78 8/50 (16.00%)  27
Pyrexia  1  65/96 (67.71%)  190 29/50 (58.00%)  108
Immune system disorders     
Allergy to animal  1  6/96 (6.25%)  15 3/50 (6.00%)  6
Food allergy  1  85/96 (88.54%)  135 43/50 (86.00%)  72
Hypersensitivity  1  39/96 (40.63%)  77 15/50 (30.00%)  25
Type I hypersensitivity  1  75/96 (78.13%)  1047 31/50 (62.00%)  152
Infections and infestations     
Bronchitis  1  3/96 (3.13%)  3 3/50 (6.00%)  4
Croup infectious  1  14/96 (14.58%)  27 5/50 (10.00%)  7
Ear infection  1  12/96 (12.50%)  14 7/50 (14.00%)  8
Gastroenteritis  1  35/96 (36.46%)  48 12/50 (24.00%)  19
Gastroenteritis viral  1  19/96 (19.79%)  27 9/50 (18.00%)  9
Hand-foot-and-mouth disease  1  6/96 (6.25%)  6 2/50 (4.00%)  2
Impetigo  1  5/96 (5.21%)  5 0/50 (0.00%)  0
Influenza  1  8/96 (8.33%)  9 7/50 (14.00%)  7
Molluscum contagiosum  1  5/96 (5.21%)  5 3/50 (6.00%)  3
Nasopharyngitis  1  8/96 (8.33%)  13 2/50 (4.00%)  8
Otitis media  1  23/96 (23.96%)  38 15/50 (30.00%)  21
Otitis media acute  1  5/96 (5.21%)  5 2/50 (4.00%)  2
Pharyngitis streptococcal  1  21/96 (21.88%)  28 3/50 (6.00%)  8
Pneumonia  1  9/96 (9.38%)  10 5/50 (10.00%)  6
Respiratory tract infection  1  1/96 (1.04%)  1 4/50 (8.00%)  4
Sinusitis  1  13/96 (13.54%)  19 5/50 (10.00%)  16
Upper respiratory tract infection  1  34/96 (35.42%)  73 18/50 (36.00%)  42
Urinary tract infection  1  0/96 (0.00%)  0 4/50 (8.00%)  4
Viral infection  1  33/96 (34.38%)  67 12/50 (24.00%)  16
Viral upper respiratory tract infection  1  26/96 (27.08%)  42 8/50 (16.00%)  14
Injury, poisoning and procedural complications     
Excoriation  1  1/96 (1.04%)  2 3/50 (6.00%)  3
Laceration  1  5/96 (5.21%)  6 2/50 (4.00%)  2
Nervous system disorders     
Headache  1  8/96 (8.33%)  11 1/50 (2.00%)  1
Psychiatric disorders     
Agitation  1  9/96 (9.38%)  10 3/50 (6.00%)  3
Respiratory, thoracic and mediastinal disorders     
Asthma  1  12/96 (12.50%)  17 8/50 (16.00%)  11
Cough  1  48/96 (50.00%)  133 23/50 (46.00%)  49
Nasal congestion  1  22/96 (22.92%)  39 9/50 (18.00%)  18
Rhinitis allergic  1  20/96 (20.83%)  33 6/50 (12.00%)  17
Rhinorrhoea  1  9/96 (9.38%)  16 2/50 (4.00%)  2
Throat irritation  1  7/96 (7.29%)  9 0/50 (0.00%)  0
Wheezing  1  17/96 (17.71%)  33 15/50 (30.00%)  22
Skin and subcutaneous tissue disorders     
Dermatitis atopic  1  9/96 (9.38%)  13 7/50 (14.00%)  8
Eczema  1  27/96 (28.13%)  65 12/50 (24.00%)  16
Erythema  1  5/96 (5.21%)  8 5/50 (10.00%)  5
Pruritus  1  15/96 (15.63%)  39 10/50 (20.00%)  17
Rash  1  24/96 (25.00%)  33 11/50 (22.00%)  24
Rash maculo-papular  1  7/96 (7.29%)  9 1/50 (2.00%)  1
Urticaria  1  24/96 (25.00%)  65 16/50 (32.00%)  29
1
Term from vocabulary, MedDRA V16.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director, Clinical Research Operations Program
Organization: DAIT/NIAID
Phone: 301-594-7669
EMail: DAITClinicalTrialsGov@niaid.nih.gov
Layout table for additonal information
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