ClinicalTrials.gov
ClinicalTrials.gov Menu

Oral Immunotherapy for Peanut Allergy (PMIT) (PMIT)

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: NCT00597675
Recruitment Status : Completed
First Posted : January 18, 2008
Results First Posted : May 3, 2017
Last Update Posted : March 27, 2018
Sponsor:
Collaborator:
University of Arkansas
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Food Hypersensitivity
Interventions Biological: Peanut OIT
Biological: Placebo
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Peanut OIT
Hide Arm/Group Description Oat flour taken daily as a placebo Peanut flour ingested daily as active OIT treatment
Period Title: Blinded Phase
Started 4 6
Completed 2 5
Not Completed 2 1
Period Title: Open Label Phase
Started 2 [1] 5
Completed 2 5
Not Completed 0 0
[1]
Patients previously on placebo were crossed over onto open label peanut OIT
Arm/Group Title Placebo Peanut OIT Total
Hide Arm/Group Description Oat flour taken daily as a placebo Peanut flour ingested daily as active OIT treatment Total of all reporting groups
Overall Number of Baseline Participants 4 6 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 4 participants 6 participants 10 participants
5.8
(4.8 to 6.9)
5.2
(3.6 to 7.0)
5.4
(3.6 to 7.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 6 participants 10 participants
Female
0
   0.0%
3
  50.0%
3
  30.0%
Male
4
 100.0%
3
  50.0%
7
  70.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 6 participants 10 participants
4 6 10
1.Primary Outcome
Title 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.
Hide Description 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.
Time Frame 36-60 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Label Peanut OIT
Hide Arm/Group Description:
All subjects on active treatment after placebo subjects have been crossed over to open label treatment
Overall Number of Participants Analyzed 7
Median (Full Range)
Unit of Measure: mg of peanut protein
5000
(3750 to 5000)
2.Secondary Outcome
Title 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.
Hide Description 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.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Peanut OIT
Hide Arm/Group Description:
Oat flour taken daily as a placebo
Peanut flour ingested daily as active OIT treatment
Overall Number of Participants Analyzed 4 5
Median (Full Range)
Unit of Measure: mg of peanut protein
123
(35 to 210)
4710
(4710 to 4710)
3.Secondary Outcome
Title The Change From Baseline Through the End of Peanut OIT Treatment in Wheal Size Diameter Following Peanut Skin Prick Testing
Hide Description 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.
Time Frame Baseline to end of open label phase treatment (36-60 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Label Peanut OIT
Hide Arm/Group Description:
All subjects on active treatment after placebo subjects have been crossed over to open label treatment
Overall Number of Participants Analyzed 7
Median (Full Range)
Unit of Measure: mm
-4.5
(-21 to 3.3)
4.Secondary Outcome
Title The Change From Baseline Through the End of Peanut OIT Treatment in Peanut-specific IgE in the Blood
Hide Description 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.
Time Frame Baseline to end of open label phase treatment (36-60 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Label Peanut OIT
Hide Arm/Group Description:
All subjects on active treatment after placebo subjects have been crossed over to open label treatment
Overall Number of Participants Analyzed 7
Median (Full Range)
Unit of Measure: kU/L
-187
(-658.5 to -19.4)
5.Secondary Outcome
Title The Change From Baseline Through the End of Peanut OIT Treatment in Peanut-specific IgG4 in the Blood.
Hide Description 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.
Time Frame Baseline to end of open label phase treatment (36-60 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Label Peanut OIT
Hide Arm/Group Description:
All subjects on active treatment after placebo subjects have been crossed over to open label treatment
Overall Number of Participants Analyzed 7
Median (Full Range)
Unit of Measure: mg/dL
6.6
(0.7 to 95.5)
Time Frame 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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Open Label Phase-Peanut OIT Blinded Phase-Placebo Blinded Phase-Peanut OIT
Hide Arm/Group Description All subjects receiving open-label peanut OIT from the point of unblinding through the end of the treatment phase. Patients receiving oat flour as a placebo during the initial 12 months of therapy. Patients receiving peanut flour as active OIT during the initial 12 months of therapy.
All-Cause Mortality
Open Label Phase-Peanut OIT Blinded Phase-Placebo Blinded Phase-Peanut OIT
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/4 (0.00%)   0/6 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Open Label Phase-Peanut OIT Blinded Phase-Placebo Blinded Phase-Peanut OIT
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/4 (0.00%)   0/6 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Open Label Phase-Peanut OIT Blinded Phase-Placebo Blinded Phase-Peanut OIT
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/9 (66.67%)   4/4 (100.00%)   6/6 (100.00%) 
Eye disorders       
Eye itch   2/9 (22.22%)  1/4 (25.00%)  1/6 (16.67%) 
Eye tearing   0/9 (0.00%)  1/4 (25.00%)  0/6 (0.00%) 
Gastrointestinal disorders       
Vomiting   2/9 (22.22%)  1/4 (25.00%)  5/6 (83.33%) 
Diarrhea   1/9 (11.11%)  1/4 (25.00%)  0/6 (0.00%) 
Oropharyngeal itching   2/9 (22.22%)  2/4 (50.00%)  1/6 (16.67%) 
Abdominal pain   2/9 (22.22%)  0/4 (0.00%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Rhinorrhea   2/9 (22.22%)  3/4 (75.00%)  5/6 (83.33%) 
Wheezing   5/9 (55.56%)  2/4 (50.00%)  1/6 (16.67%) 
Sneezing   2/9 (22.22%)  1/4 (25.00%)  0/6 (0.00%) 
Cough   2/9 (22.22%)  3/4 (75.00%)  1/6 (16.67%) 
Nasal congestion   0/9 (0.00%)  0/4 (0.00%)  0/6 (0.00%) 
Skin and subcutaneous tissue disorders       
Erythematous rash   3/9 (33.33%)  3/4 (75.00%)  1/6 (16.67%) 
Itchy nose   1/9 (11.11%)  1/4 (25.00%)  0/6 (0.00%) 
Skin itch   1/9 (11.11%)  2/4 (50.00%)  1/6 (16.67%) 
Lip or eye swelling   3/9 (33.33%)  1/4 (25.00%)  2/6 (33.33%) 
Hives   5/9 (55.56%)  1/4 (25.00%)  1/6 (16.67%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Edwin Kim, Director of the UNC Food Allergy Initiative
Organization: University of North Carolina at Chapel Hill
Phone: 919-843-9087
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00597675     History of Changes
Other Study ID Numbers: Pro00000163
First Submitted: January 4, 2008
First Posted: January 18, 2008
Results First Submitted: January 25, 2017
Results First Posted: May 3, 2017
Last Update Posted: March 27, 2018