Peanut AllergyNCT01812798
Canadian Peanut Thresholds Study
A study of Peanut Allergy, run by McMaster University at 1 site in Canada.
Trial summary
An important gap in the management of peanut allergy is that we do not know the threshold dose, below which most peanut allergic individuals will not react. There is likely a spectrum of reactivity to peanut where some individuals react to trace doses, whereas others are able to tolerate larger doses. Read more about this study
- Who is it for?
- Ages 7 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Peanut Allergy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- May 2013to Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Children and adults between 7-65 years of age.
- Demonstrated history of peanut allergy based on medical history, positive skin prick test, and peanut-specific IgE CAP-FEIA test. Participants will be confirmed to have peanut allergy based on a history of significant clinical symptoms within 60 minutes of the ingestion of peanut, the presence of specific IgE to peanut (a positive skin prick test to peanut, defined as a wheal 3 mm larger than that of the saline control, and a positive in vitro peanut-specific IgE (CAP-FEIA) test value >0.35 IU/mL.
- Ability to discontinue all prescribed and over the counter allergy-related medications for suitable withdrawal periods before starting the challenge trial. See Appendix I for specifications.
Who cannot join
- Previous desensitization treatment to peanut
- Allergies to any component of the oral challenge matrix
- Unstable allergic conditions such as uncontrolled asthma or chronic urticaria
- Any clinically significant disease/chronic medical condition which may interfere with study evaluations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Disease Management: Canadian Peanut Thresholds Study
An important gap in the management of peanut allergy is that we do not know the threshold dose, below which most peanut allergic individuals will not react. There is likely a spectrum of reactivity to peanut where some individuals react to trace doses, whereas others are able to tolerate larger doses. The purpose of this study is to determine the minimum threshold dose needed to cause a mild objective reaction when peanuts are consumed by peanut-allergic individuals in a carefully controlled clinical setting. 30 peanut-allergic participants aged 7-65 years will undergo a two-day, double blind placebo controlled food challenge. Participants will be gradually fed increasing amounts of peanut, or placebo, until objective allergic symptoms are observed. Statistical modelling of individual threshold doses will be used to determine a population threshold dose, or a level of peanut to which 90% of the peanut-allergic population will not react. Knowledge of threshold doses at an individual and population level is valuable in that it provides critical information for the management of peanut allergy by individuals, their caregivers and health professionals, as well as knowledge of allergen risks to public health agencies and the food industry.
Read the detailed description
Overview
This study protocol will be modeled on a consensus protocol developed with the input of clinical allergists and other allergy stakeholders to standardize threshold challenge studies [5-8]. As per protocol, 30 patients with a known or convincing history of peanut allergy will be recruited. After an initial screening visit to verify eligibility, all participants will undergo a two-day DBPCFC. Briefly, qualifying participants will be fed increasing amounts of peanut masked in a food matrix. On a different day, the participant will be fed the same amount of the food matrix without any peanut. Overall, the study will require three visits by participants: a screening day to determine if the prospective participants meet eligibility criteria, and two days for the DBPCFC.
Study Procedures
Screening Visit
Prospective participants will come to the Allergy Clinic at the McMaster University Medical Centre for a screening visit up to 6 months prior to the DBPCFC in order to confirm study eligibility. The informed consent form will be reviewed and signed at this time. The allergic status of these prospective participants will be characterized by patient history, skin prick test (SPT), and peanut-specific IgE, so that they can be related to the overall allergic population. Relevant history (all reactions related to peanut and any other foods, other allergic co-morbidities, other medical conditions, medications, family history, etc.) will be recorded. A physical examination will be performed including skin prick tests to peanut and the routine inhalant allergen panel. Blood work will be done as a baseline measure and analyzed as described below.
Skin Prick Test (SPT)
As a positive SPT is needed to qualify participants for the study, each prospective participant will have a SPT during the screening visit. SPTs will be judged and recorded based on the size of the wheal (raised welt around prick site) and flare (reddened area around wheal) as compared to the positive and negative control skin tests after 15-30 minutes [9]. A SPT is deemed positive by comparison to the negative control skin test. Skin test reaction wheals with diameters 3 mm greater than those of the negative saline control are considered positive. The diameter of the wheal and the diameter of the wheal and flare will be recorded. A record of the peanut SPT size will be kept via cellophane tape recording.
Blood draw
During the screening visit, a blood sample will be taken from prospective participants in order to test the in vitro peanut-specific IgE level. The amount of blood drawn will be dependent on the age and weight of the subject (see Appendix III). The blood will be separated so that the serum can be submitted for specific testing against peanut proteins. Testing for IgE to peanut requires only a few milliliters of serum. The remaining serum will be used to identify specific proteins in peanuts that bind IgE from each subject's serum and characterization of those peanut proteins. Serum samples will be coded to protect the identity of the subjects, stored at McMaster University Medical Centre, and used until supplies are exhausted.
Double Blind Placebo Controlled Food Challenge
Participants will come to the Allergy Clinic at McMaster University Medical Centre for the DBPCFC, which will take 2 days. Each visit will last a minimum of 4 hours with a minimum of one week between the food challenge visits. Oral food challenges will occur in a clinical setting allowing for prompt medical treatment if necessary during the protocol. Participants will be monitored by qualified medical personnel. An IV will be put in place prior to the start of the challenge. In the extremely unlikely event that the subject has a severe reaction during the challenge, a code cart or special emergency supplies including intubation equipment and defibrillator will be available and epinephrine and other medications will be administered according to the severity of reaction.
Each participant will be randomized to receive either peanut on Day 1 and placebo on Day 2 or vice versa. The randomization process and challenge materials are described in detail below. On the 'peanut' day, participants will be orally challenged with 17 doses of peanut masked in a suitable food matrix, such as applesauce or chocolate pudding. To ensure the establishment of a NOAEL, the starting dose will be 0.1mg, 50-30 times lower than what has previously been reported. The progression of dosing will follow a defined schedule up to 5000g. On a separate day, participants will be challenged with an equivalent series of placebo doses.
To start the challenge, each participant will be given a small amount of either peanut (masked in the challenge vehicle) starting at 0.1 mg or placebo. Doses will be given at 20-30 minute intervals and participants will be monitored continuously between doses. The dose of peanut will be increased following the progression above until:
- One or more of the following objective findings are observed:
- Rash: erythema, morbilliform rash, urticarial, angioedema
- Ocular: conjunctival swelling, scleral edema, tearing
- Nasal: congestion, rhinorrhea, sneezing
- Gastrointestinal: vomiting, diarrhea
- Systemic: blood pressure drop by ≥ 20%
- The final dose of peanut is reached
- Physician's discretion
All subjective and objective symptoms will be fully recorded on the data collection forms. Vital signs (oxygen saturation, blood pressure, heart rate, respiratory rate) will be assessed before every dose, with every new subjective symptom reported, and when objective findings are observed. The challenge may be stopped at the discretion of the principal investigator if the participant cannot tolerate the subjective symptoms. Once objective reactive symptoms are observed, the challenge will immediately be stopped and the participant will receive appropriate medication which may include epinephrine, antihistamine, or steroids to manage the reaction. Participants will be observed for a minimum of 2 hours after an allergic reaction has occurred to ensure that it has been adequately treated and resolved.
- Conditions
- Peanut Allergy
- Being tested
- Double Blind Placebo Controlled Food Challenge
- Keywords
- Peanut allergy, Threshold, Modelling, Risk assessment
- Medical subject headings
- Peanut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double Blind Placebo Controlled Food ChallengeOther
All participants will undergo Double Blind Placebo Controlled Food Challenge. Participants will be randomized to receive either Peanut on Day 1, Placebo on Day 2, or vice versa.
For 'Peanut' arm, participants will be fed increasing doses of peanut until mild objective allergic reaction is observed.
Doses will be increased every 20-30 minutes. All doses are listed in g peanut flour
0.1 0.25 0.5 0.75
1 2.5 5 10 25 50 100 250 500 750 1000 2500 5000
For "Placebo" arm, participants will be fed increasing amounts of food matrix without peanut flour.
| Study group | Role | What they receive |
|---|---|---|
| Peanut | Active comparator | Double Blind Placebo Controlled Food Challenge 5 gram peanut challenge
17 doses of peanut will be administered. Dose will be increased every 20-30 minutes. All doses listed are in g of peanut flour.
0.1 0.25 0.5 0.75
1 2.5 5 10 25 50 100 250 500 750 1000 2500 5000 Receives: Other: Double Blind Placebo Controlled Food Challenge |
| Placebo | Placebo comparator | Double Blind Placebo Controlled Food Challenge (No peanut - placebo only) Receives: Other: Double Blind Placebo Controlled Food Challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peanut threshold dose
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2013 (estimated)
- Study startMay 2013
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peanut AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- AllerGen NCE Inc.
- Responsible party
- Sponsor
- Investigators
- Susan Waserman, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01812798
- Sponsor's protocol ID
- 12LP3.7
- Status last verified
- May 2020
- First submitted
- 14 Mar 2013
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disease Management: Canadian Peanut Thresholds Study
- ClinicalTrials.gov ID
- NCT01812798
- Acronym / sponsor ID
- 12LP3.7
- Conditions
- Peanut Allergy
- Keywords
- Peanut allergy, Threshold, Modelling, Risk assessment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- AllerGen NCE Inc.
- Study start
- May 2013
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 18 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An important gap in the management of peanut allergy is that we do not know the threshold dose, below which most peanut allergic individuals will not react. There is likely a spectrum of reactivity to peanut where some individuals react to trace doses, whereas others are able to tolerate larger doses. The purpose of this study is to determine the minimum threshold dose needed to cause a mild objective reaction when peanuts are consumed by peanut-allergic individuals in a carefully controlled clinical setting. 30 peanut-allergic participants aged 7-65 years will undergo a two-day, double blind placebo controlled food challenge. Participants will be gradually fed increasing amounts of peanut, or placebo, until objective allergic symptoms are observed. Statistical modelling of individual threshold doses will be used to determine a population threshold dose, or a level of peanut to which 90% of the peanut-allergic population will not react. Knowledge of threshold doses at an individual and population level is valuable in that it provides critical information for the management of peanut allergy by individuals, their caregivers and health professionals, as well as knowledge of allergen risks to public health agencies and the food industry.
Detailed description
Overview
This study protocol will be modeled on a consensus protocol developed with the input of clinical allergists and other allergy stakeholders to standardize threshold challenge studies [5-8]. As per protocol, 30 patients with a known or convincing history of peanut allergy will be recruited. After an initial screening visit to verify eligibility, all participants will undergo a two-day DBPCFC. Briefly, qualifying participants will be fed increasing amounts of peanut masked in a food matrix. On a different day, the participant will be fed the same amount of the food matrix without any peanut. Overall, the study will require three visits by participants: a screening day to determine if the prospective participants meet eligibility criteria, and two days for the DBPCFC.
Study Procedures
Screening Visit
Prospective participants will come to the Allergy Clinic at the McMaster University Medical Centre for a screening visit up to 6 months prior to the DBPCFC in order to confirm study eligibility. The informed consent form will be reviewed and signed at this time. The allergic status of these prospective participants will be characterized by patient history, skin prick test (SPT), and peanut-specific IgE, so that they can be related to the overall allergic population. Relevant history (all reactions related to peanut and any other foods, other allergic co-morbidities, other medical conditions, medications, family history, etc.) will be recorded. A physical examination will be performed including skin prick tests to peanut and the routine inhalant allergen panel. Blood work will be done as a baseline measure and analyzed as described below.
Skin Prick Test (SPT)
As a positive SPT is needed to qualify participants for the study, each prospective participant will have a SPT during the screening visit. SPTs will be judged and recorded based on the size of the wheal (raised welt around prick site) and flare (reddened area around wheal) as compared to the positive and negative control skin tests after 15-30 minutes [9]. A SPT is deemed positive by comparison to the negative control skin test. Skin test reaction wheals with diameters 3 mm greater than those of the negative saline control are considered positive. The diameter of the wheal and the diameter of the wheal and flare will be recorded. A record of the peanut SPT size will be kept via cellophane tape recording.
Blood draw
During the screening visit, a blood sample will be taken from prospective participants in order to test the in vitro peanut-specific IgE level. The amount of blood drawn will be dependent on the age and weight of the subject (see Appendix III). The blood will be separated so that the serum can be submitted for specific testing against peanut proteins. Testing for IgE to peanut requires only a few milliliters of serum. The remaining serum will be used to identify specific proteins in peanuts that bind IgE from each subject's serum and characterization of those peanut proteins. Serum samples will be coded to protect the identity of the subjects, stored at McMaster University Medical Centre, and used until supplies are exhausted.
Double Blind Placebo Controlled Food Challenge
Participants will come to the Allergy Clinic at McMaster University Medical Centre for the DBPCFC, which will take 2 days. Each visit will last a minimum of 4 hours with a minimum of one week between the food challenge visits. Oral food challenges will occur in a clinical setting allowing for prompt medical treatment if necessary during the protocol. Participants will be monitored by qualified medical personnel. An IV will be put in place prior to the start of the challenge. In the extremely unlikely event that the subject has a severe reaction during the challenge, a code cart or special emergency supplies including intubation equipment and defibrillator will be available and epinephrine and other medications will be administered according to the severity of reaction.
Each participant will be randomized to receive either peanut on Day 1 and placebo on Day 2 or vice versa. The randomization process and challenge materials are described in detail below. On the 'peanut' day, participants will be orally challenged with 17 doses of peanut masked in a suitable food matrix, such as applesauce or chocolate pudding. To ensure the establishment of a NOAEL, the starting dose will be 0.1mg, 50-30 times lower than what has previously been reported. The progression of dosing will follow a defined schedule up to 5000g. On a separate day, participants will be challenged with an equivalent series of placebo doses.
To start the challenge, each participant will be given a small amount of either peanut (masked in the challenge vehicle) starting at 0.1 mg or placebo. Doses will be given at 20-30 minute intervals and participants will be monitored continuously between doses. The dose of peanut will be increased following the progression above until:
- One or more of the following objective findings are observed:
- Rash: erythema, morbilliform rash, urticarial, angioedema
- Ocular: conjunctival swelling, scleral edema, tearing
- Nasal: congestion, rhinorrhea, sneezing
- Gastrointestinal: vomiting, diarrhea
- Systemic: blood pressure drop by ≥ 20%
- The final dose of peanut is reached
- Physician's discretion
All subjective and objective symptoms will be fully recorded on the data collection forms. Vital signs (oxygen saturation, blood pressure, heart rate, respiratory rate) will be assessed before every dose, with every new subjective symptom reported, and when objective findings are observed. The challenge may be stopped at the discretion of the principal investigator if the participant cannot tolerate the subjective symptoms. Once objective reactive symptoms are observed, the challenge will immediately be stopped and the participant will receive appropriate medication which may include epinephrine, antihistamine, or steroids to manage the reaction. Participants will be observed for a minimum of 2 hours after an allergic reaction has occurred to ensure that it has been adequately treated and resolved.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peanut | Active comparator | Other: Double Blind Placebo Controlled Food ChallengeDouble Blind Placebo Controlled Food Challenge 5 gram peanut challenge 17 doses of peanut will be administered. Dose will be increased every 20-30 minutes. All doses listed are in g of peanut flour. 0.1 0.25 0.5 0.75 1 2.5 5 10 25 50 100 250 500 750 1000 2500 5000 |
| Placebo | Placebo comparator | Other: Double Blind Placebo Controlled Food ChallengeDouble Blind Placebo Controlled Food Challenge (No peanut - placebo only) |
Who may qualify
- Ages
- 7 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Children and adults between 7-65 years of age.
- Demonstrated history of peanut allergy based on medical history, positive skin prick test, and peanut-specific IgE CAP-FEIA test. Participants will be confirmed to have peanut allergy based on a history of significant clinical symptoms within 60 minutes of the ingestion of peanut, the presence of specific IgE to peanut (a positive skin prick test to peanut, defined as a wheal 3 mm larger than that of the saline control, and a positive in vitro peanut-specific IgE (CAP-FEIA) test value >0.35 IU/mL.
- Ability to discontinue all prescribed and over the counter allergy-related medications for suitable withdrawal periods before starting the challenge trial. See Appendix I for specifications.
Key exclusion criteria (4 listed)
- Previous desensitization treatment to peanut
- Allergies to any component of the oral challenge matrix
- Unstable allergic conditions such as uncontrolled asthma or chronic urticaria
- Any clinically significant disease/chronic medical condition which may interfere with study evaluations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Double Blind Placebo Controlled Food ChallengeAll participants will undergo Double Blind Placebo Controlled Food Challenge. Participants will be randomized to receive either Peanut on Day 1, Placebo on Day 2, or vice versa. For 'Peanut' arm, participants will be fed increasing doses of peanut until mild objective allergic reaction is observed. Doses will be increased every 20-30 minutes. All doses are listed in g peanut flour 0.1 0.25 0.5 0.75 1 2.5 5 10 25 50 100 250 500 750 1000 2500 5000 For "Placebo" arm, participants will be fed increasing amounts of food matrix without peanut flour. | Other | Peanut, Placebo |
Primary outcome
Peanut threshold dose
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
Related trials for Peanut Allergy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Waserman, MD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Peanut Allergy, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peanut threshold dose (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.