Trial Outcomes & Findings for High Threshold Peanut Challenge Study (NCT NCT02698033)

Results Overview

The proportion of high-threshold peanut allergic individuals among participants who previously failed to react to a 443 mg peanut protein challenge in NCT01750879 who also reacted \>443 cumulative total dose on repeat challenge

Recruitment status

COMPLETED

Target enrollment

20 participants

Primary outcome timeframe

4 weeks

Results posted on

2019-10-03

Participant Flow

Participant milestones

Participant milestones
Measure	Peanut Flour Double Blind Oral food challenge to peanut Peanut flour: A food challenge will consist of two challenges performed on separate days. One challenge will consist of 7 doses of peanut given every 20 minutes in increasing amounts up to a total of 7 grams of whole peanut (4 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.
Overall Study STARTED	7
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Peanut Flour n=7 Participants Double-blind food challenge with peanut flour Peanut flour: A Double-blind, placebo-controlled food challenge will consist of two challenges performed on separate days. One challenge will consist of 7 doses of peanut given every 20 minutes in increasing amounts up to a total of 7 grams of whole peanut (4 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.
Age, Categorical <=18 years	6 Participants n=7 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=7 Participants
Age, Categorical >=65 years	0 Participants n=7 Participants
Sex: Female, Male Female	2 Participants n=7 Participants
Sex: Female, Male Male	5 Participants n=7 Participants
Region of Enrollment United States	7 participants n=7 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: 1 refused repeat challenge due to other allergic reactivity at time of scheduled procedure

The proportion of high-threshold peanut allergic individuals among participants who previously failed to react to a 443 mg peanut protein challenge in NCT01750879 who also reacted \>443 cumulative total dose on repeat challenge

Outcome measures

Outcome measures
Measure	Peanut Flour n=6 Participants Double-blind food challenge with peanut flour Peanut flour: A Double-blind, placebo-controlled food challenge will consist of two challenges performed on separate days. One challenge will consist of 7 doses of peanut given every 20 minutes in increasing amounts up to a total of 7 grams of whole peanut (4 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.
Consistency of High Threshold Reactivity	6 Participants

Adverse Events

Peanut Flour

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Wayne Shreffler

Massachusetts General Hospital

Phone: 6177266147

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place