Trial Outcomes & Findings for Oral Immunotherapy for Peanut Allergy (PMIT) (NCT NCT00597675)
NCT ID: NCT00597675
Last Updated: 2018-03-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
36-60 months
Results posted on
2018-03-27
Participant Flow
Participant milestones
| Measure |
Placebo
Oat flour taken daily as a placebo
|
Peanut OIT
Peanut flour ingested daily as active OIT treatment
|
|---|---|---|
|
Blinded Phase
STARTED
|
4
|
6
|
|
Blinded Phase
COMPLETED
|
2
|
5
|
|
Blinded Phase
NOT COMPLETED
|
2
|
1
|
|
Open Label Phase
STARTED
|
2
|
5
|
|
Open Label Phase
COMPLETED
|
2
|
5
|
|
Open Label Phase
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Oral Immunotherapy for Peanut Allergy (PMIT)
Baseline characteristics by cohort
| Measure |
Placebo
n=4 Participants
Oat flour taken daily as a placebo
|
Peanut OIT
n=6 Participants
Peanut flour ingested daily as active OIT treatment
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
5.8 years
n=5 Participants
|
5.2 years
n=7 Participants
|
5.4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 36-60 monthsAfter 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.
Outcome measures
| Measure |
Open Label Peanut OIT
n=7 Participants
All subjects on active treatment after placebo subjects have been crossed over to open label treatment
|
Peanut OIT
Peanut flour ingested daily as active OIT treatment
|
|---|---|---|
|
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.
|
5000 mg of peanut protein
Interval 3750.0 to 5000.0
|
—
|
SECONDARY outcome
Timeframe: 12 monthsAfter 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.
Outcome measures
| Measure |
Open Label Peanut OIT
n=4 Participants
All subjects on active treatment after placebo subjects have been crossed over to open label treatment
|
Peanut OIT
n=5 Participants
Peanut flour ingested daily as active OIT treatment
|
|---|---|---|
|
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.
|
123 mg of peanut protein
Interval 35.0 to 210.0
|
4710 mg of peanut protein
Interval 4710.0 to 4710.0
|
SECONDARY outcome
Timeframe: Baseline to end of open label phase treatment (36-60 months)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.
Outcome measures
| Measure |
Open Label Peanut OIT
n=7 Participants
All subjects on active treatment after placebo subjects have been crossed over to open label treatment
|
Peanut OIT
Peanut flour ingested daily as active OIT treatment
|
|---|---|---|
|
The Change From Baseline Through the End of Peanut OIT Treatment in Wheal Size Diameter Following Peanut Skin Prick Testing
|
-4.5 mm
Interval -21.0 to 3.3
|
—
|
SECONDARY outcome
Timeframe: Baseline to end of open label phase treatment (36-60 months)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.
Outcome measures
| Measure |
Open Label Peanut OIT
n=7 Participants
All subjects on active treatment after placebo subjects have been crossed over to open label treatment
|
Peanut OIT
Peanut flour ingested daily as active OIT treatment
|
|---|---|---|
|
The Change From Baseline Through the End of Peanut OIT Treatment in Peanut-specific IgE in the Blood
|
-187 kU/L
Interval -658.5 to -19.4
|
—
|
SECONDARY outcome
Timeframe: Baseline to end of open label phase treatment (36-60 months)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.
Outcome measures
| Measure |
Open Label Peanut OIT
n=7 Participants
All subjects on active treatment after placebo subjects have been crossed over to open label treatment
|
Peanut OIT
Peanut flour ingested daily as active OIT treatment
|
|---|---|---|
|
The Change From Baseline Through the End of Peanut OIT Treatment in Peanut-specific IgG4 in the Blood.
|
6.6 mg/dL
Interval 0.7 to 95.5
|
—
|
Adverse Events
Open Label Phase-Peanut OIT
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Blinded Phase-Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Blinded Phase-Peanut OIT
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Open Label Phase-Peanut OIT
n=9 participants at risk
All subjects receiving open-label peanut OIT from the point of unblinding through the end of the treatment phase.
|
Blinded Phase-Placebo
n=4 participants at risk
Patients receiving oat flour as a placebo during the initial 12 months of therapy.
|
Blinded Phase-Peanut OIT
n=6 participants at risk
Patients receiving peanut flour as active OIT during the initial 12 months of therapy.
|
|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
22.2%
2/9 • 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.
|
25.0%
1/4 • 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.
|
83.3%
5/6 • 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.
|
|
Gastrointestinal disorders
Diarrhea
|
11.1%
1/9 • 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.
|
25.0%
1/4 • 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.
|
0.00%
0/6 • 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.
|
|
Skin and subcutaneous tissue disorders
Erythematous rash
|
33.3%
3/9 • 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.
|
75.0%
3/4 • 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.
|
16.7%
1/6 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
22.2%
2/9 • 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.
|
75.0%
3/4 • 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.
|
83.3%
5/6 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
55.6%
5/9 • 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.
|
50.0%
2/4 • 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.
|
16.7%
1/6 • 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.
|
|
Gastrointestinal disorders
Oropharyngeal itching
|
22.2%
2/9 • 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.
|
50.0%
2/4 • 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.
|
16.7%
1/6 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
22.2%
2/9 • 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.
|
25.0%
1/4 • 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.
|
0.00%
0/6 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.2%
2/9 • 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.
|
75.0%
3/4 • 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.
|
16.7%
1/6 • 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.
|
|
Skin and subcutaneous tissue disorders
Itchy nose
|
11.1%
1/9 • 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.
|
25.0%
1/4 • 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.
|
0.00%
0/6 • 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.
|
|
Skin and subcutaneous tissue disorders
Skin itch
|
11.1%
1/9 • 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.
|
50.0%
2/4 • 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.
|
16.7%
1/6 • 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.
|
|
Skin and subcutaneous tissue disorders
Lip or eye swelling
|
33.3%
3/9 • 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.
|
25.0%
1/4 • 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.
|
33.3%
2/6 • 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.
|
|
Eye disorders
Eye itch
|
22.2%
2/9 • 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.
|
25.0%
1/4 • 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.
|
16.7%
1/6 • 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.
|
|
Eye disorders
Eye tearing
|
0.00%
0/9 • 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.
|
25.0%
1/4 • 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.
|
0.00%
0/6 • 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.
|
|
Skin and subcutaneous tissue disorders
Hives
|
55.6%
5/9 • 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.
|
25.0%
1/4 • 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.
|
16.7%
1/6 • 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.
|
|
Gastrointestinal disorders
Abdominal pain
|
22.2%
2/9 • 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.
|
0.00%
0/4 • 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.
|
0.00%
0/6 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/9 • 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.
|
0.00%
0/4 • 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.
|
0.00%
0/6 • 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.
|
Additional Information
Dr. Edwin Kim, Director of the UNC Food Allergy Initiative
University of North Carolina at Chapel Hill
Phone: 919-843-9087
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place