Oral Immunotherapy (OIT) for Peanut Allergy (PnOIT3)
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|ClinicalTrials.gov Identifier: NCT00815035|
Recruitment Status : Completed
First Posted : December 29, 2008
Results First Posted : May 15, 2017
Last Update Posted : March 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Peanut Hypersensitivity||Drug: Peanut OIT Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Oral Immunotherapy for Peanut Allergy- Peanut Oral Immunotherapy (PnOIT3)|
|Study Start Date :||April 2009|
|Primary Completion Date :||December 12, 2016|
|Study Completion Date :||December 12, 2016|
Active Comparator: Peanut OIT
Subjects randomized to receive active treatment with peanut protein flour.
Drug: Peanut OIT
Peanut flour that is orally ingested in a graded fashion.
Other Name: Peanut flour
Placebo Comparator: Placebo
Subjects randomized to receive placebo in the form of oat flour.
Oat flour used as a placebo that is orally ingested a graded fashion
Other Name: Oat flour
- Percentage of Subjects Achieving Tolerance as Defined by a Negative DBPCFC 4 Weeks After Discontinuation of Peanut OIT Therapy. [ Time Frame: 61 months for those randomized to active treatment and 73 months for those randomized to placebo for the initial 12 months of therapy ]Upon completion of 60 months of peanut OIT treatment, subjects discontinued peanut OIT for 4 weeks. The primary clinical efficacy outcome of the study was the percentage of peanut allergic subjects who completed a 5 gm peanut protein double-blind placebo controlled food challenge (DBPCPFC) without developing symptoms 4 weeks after discontinuing peanut OIT.
- The Percentage of Subjects Achieving Full Desensitization as Defined by a Negative DBPCFC After 60 Months of Peanut OIT Therapy. [ Time Frame: 60 months for those randomized to active treatment and 72 months for those randomized to placebo for the initial 12 months of therapy ]Upon completion of 60 months of peanut OIT treatment, subjects underwent a double-blind placebo controlled food challenge (DBPCPFC) to assess desensitization. The secondary clinical efficacy outcome of the study was the percentage of peanut allergic subjects who completed a 5 gm peanut protein double-blind placebo controlled food challenge (DBPCPFC) without developing symptoms after completing peanut OIT therapy.
- The Percentage of Subjects Who Tolerated the Initial-day Escalation to 6 mg of Peanut [ Time Frame: first day of peanut OIT dosing ]The first day of peanut OIT dosing involved multiple increasing doses of peanut flour in what was called an initial escalation day up to a maximum dose of 6 mg of peanut protein. The secondary outcome measure assessed the percentage of subjects were successfully able to reach this 6 mg dose.
- The Percentage of Subjects Who Are Successfully Able to Escalate up to the 4000 mg Maximum Maintenance Dose of Peanut Protein OIT During the 60 Month Desensitization Phase of the Study [ Time Frame: approximately 40 weeks (10 months) ]During the desensitization phase of the study, subjects under go an initial day escalation up to a maximum of 6 mg of peanut protein. They then undergo biweekly dose escalation over approximately 10 months up to a maximum dose of 4000 mg of peanut protein. This outcome reports the percentage of subjects that achieve this.
- Incidence of All Serious Adverse Events During the Study [ Time Frame: 61 months for those randomized to active peanut OIT and 73 months for those randomized to placebo for the initial 12 months of the study. ]All serious adverse events during the blinded and open-label phases of the study were recorded and reported as a safety outcome.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00815035
|United States, North Carolina|
|University of North Carolina|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Wesley Burks, MD||University of North Carolina|