Peanut AllergyPhase 2NCT01601522
Peanut Allergy Oral Immunotherapy Desensitization
A Phase 2 study testing Peanut protein, Oat flour and Antihistamine in people with Peanut Allergy, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
The purpose of the study is to determine how a type of treatment for peanut allergy known as oral desensitization works in the immune system. Objectives 1. To determine whether premedication with desloratidine and ranitidine results in fewer side effects during desensitization procedure. 2. Read more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Peanut Allergy
- What is being tested?
- Peanut protein, Oat flour and Antihistamine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2012to Sep 2021
- Phase
- Phase 2
- 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 5 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients must be between 5 and 10 years of age.
- Patients will be confirmed to have peanut allergy based on a history of significant clinical symptoms within 60 minutes after 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 IgE [CAP-FEIA] result of >15 kU/L..
- Patients will also be accepted into the study if they have a clinical reaction to peanut ingestion within the past 6 months, a positive skin prick test to peanut as defined previously, and an in vitro peanut IgE (CAP-FEIA) result of 7 kU/L or greater.
- Subjects must be free of any clinically significant disease which may interfere with study evaluations.
Who cannot join
- Use of antihistamines or decongestant therapy 7 days prior to the clinic visit. (antihistamines eg. diphenhydramine, desloratadine etc or throughout the desensitization phase of the study.
- Patients who had an acute allergic reaction to food other than peanut, drugs, or stinging insects one month prior to the recruitment clinic visit
- Patients who have had a respiratory infection one month prior to the recruitment clinic visit.
- Patients with significant or uncontrolled asthma, (inhaled corticosteroids (fluticasone >500 mcg per day, ciclesonide >400 mcg per day or budesonide >800 mcg per day or the corresponding combination inhalers, oral prednisone in the preceding 1 month and FEV1 < 80% predicted). Nasal steroids, bronchodilators and leukotriene inhibitors will be permitted. If Prednisone is taken, it must also be stopped 1 month prior to blood being drawn if possible.
- Patients who received allergy injections (immunotherapy) to environmental allergens at any time in the past. Symptomatic atopic dermatitis or chronic urticaria which may interfere with ability to evaluate oral immunotherapy and /or requiring daily medication including antihistamines.
- Patients with problems related to compliance or following study instructions. Inability to come to hospital every 2 weeks for dose escalation.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to determine how a type of treatment for peanut allergy known as oral desensitization works in the immune system.
Objectives
- To determine whether premedication with desloratidine and ranitidine results in fewer side effects during desensitization procedure.
- To assess quality of life in peanut allergic subjects before and after desensitization.
- To compare serum metabolites in peanut allergic and non peanut allergic subjects.
Read the detailed description
Allergic reactions to peanuts and tree nuts account for the majority of fatal and near fatal food allergic reactions, and the only treatment is complete avoidance of peanut. Despite avoidance, the majority of peanut allergic people will accidently ingest peanut. OIT has been shown to desensitize peanut allergic subjects (Hofmann et al. 2009). This would protect patients who have no other treatment, and may even form the basis for true tolerance to peanut in the future.
Objectives:
- To determine whether premedication with desloratidine and ranitidine results in fewer side effects during desensitization procedure.
- To assess quality of life in peanut allergic subjects before and after desensitization.
- To compare serum metabolites in peanut allergic and non peanut allergic subjects.
- Conditions
- Peanut Allergy
- Being tested
- Peanut protein, Oat flour, Antihistamine
- Medical subject headings
- Peanut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peanut proteinProcedure or surgery
Also called Old Birginia Byrd Mill 12% Lightly Roasted Peanut Flour
500 mg
Oat flourProcedure or surgery
500 mg Oat flour
AntihistamineDrug
Also called Desloratadine and Ranitidine
Desloratidine 5 ml po od (0.5mg/ml = 2.5 mg) Ranitidine 5ml (15mg/ml=75 mg) po bid
| Study group | Role | What they receive |
|---|---|---|
| Oral Immunotherapy with placebo antihistamines | Experimental | 500 mg Peanut Protein with placebo antihistamines Receives: Procedure: Peanut protein |
| Double Placebo | Placebo comparator | Placebo (Oat flour) and placebo antihistamines Receives: Procedure: Oat flour |
| Oral Immunotherapy with H1 and H2 antihistamines | Active comparator | 500 mg Peanut Protein with Dosage of desloratidine 5 ml po od (0.5mg/ml = 2.5 mg) and ranitidine be 5ml (15mg/ml=75 mg) po bid. Receives: Procedure: Peanut protein; Drug: Antihistamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse effects
Frequency and risk of adverse events, overall and stratified by organ system and severity
Measured: 6-12 months
Secondary outcomes (2)
Health related quality of life pre and post intervention
Pre and post OIT.
Measured: 6-12 months
Eliciting doses to oral food challenge
Patients will be challenged at the end of the treatment period with peanut at the end to determine the change from threshold that they are able to tolerate.
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2012 (estimated)
- Study startFeb 2012
- Primary completionSep 2021
- Study completionSep 2021
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- AllerGen NCE Inc., McMaster University
- Responsible party
- Principal investigator, Dr. Susan Waserman, McMaster University
- Investigators
- Susan Waserman, ME, Principal investigator, McMaster UniversitySusan Waserman, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01601522
- Sponsor's protocol ID
- REB 07-348
- Status last verified
- Jan 2022
- First submitted
- 27 Jul 2011
- Last updated
- 2 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peanut Allergy Oral Immunotherapy Desensitization
- ClinicalTrials.gov ID
- NCT01601522
- Acronym / sponsor ID
- REB 07-348
- Conditions
- Peanut Allergy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- AllerGen NCE Inc., McMaster University
- Study start
- Feb 2012
- Primary completion
- Sep 2021 (actual)
- Study completion
- Sep 2021 (actual)
- First posted
- 18 May 2012 (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.
The purpose of the study is to determine how a type of treatment for peanut allergy known as oral desensitization works in the immune system.
Objectives
- To determine whether premedication with desloratidine and ranitidine results in fewer side effects during desensitization procedure.
- To assess quality of life in peanut allergic subjects before and after desensitization.
- To compare serum metabolites in peanut allergic and non peanut allergic subjects.
Detailed description
Allergic reactions to peanuts and tree nuts account for the majority of fatal and near fatal food allergic reactions, and the only treatment is complete avoidance of peanut. Despite avoidance, the majority of peanut allergic people will accidently ingest peanut. OIT has been shown to desensitize peanut allergic subjects (Hofmann et al. 2009). This would protect patients who have no other treatment, and may even form the basis for true tolerance to peanut in the future.
Objectives:
- To determine whether premedication with desloratidine and ranitidine results in fewer side effects during desensitization procedure.
- To assess quality of life in peanut allergic subjects before and after desensitization.
- To compare serum metabolites in peanut allergic and non peanut allergic subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oral Immunotherapy with placebo antihistamines | Experimental | Procedure: Peanut protein500 mg Peanut Protein with placebo antihistamines |
| Double Placebo | Placebo comparator | Procedure: Oat flourPlacebo (Oat flour) and placebo antihistamines |
| Oral Immunotherapy with H1 and H2 antihistamines | Active comparator | Procedure: Peanut protein, Drug: Antihistamine500 mg Peanut Protein with Dosage of desloratidine 5 ml po od (0.5mg/ml = 2.5 mg) and ranitidine be 5ml (15mg/ml=75 mg) po bid. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients must be between 5 and 10 years of age.
- Patients will be confirmed to have peanut allergy based on a history of significant clinical symptoms within 60 minutes after 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 IgE [CAP-FEIA] result of >15 kU/L..
- Patients will also be accepted into the study if they have a clinical reaction to peanut ingestion within the past 6 months, a positive skin prick test to peanut as defined previously, and an in vitro peanut IgE (CAP-FEIA) result of 7 kU/L or greater.
- Subjects must be free of any clinically significant disease which may interfere with study evaluations.
Key exclusion criteria (6 listed)
- Use of antihistamines or decongestant therapy 7 days prior to the clinic visit. (antihistamines eg. diphenhydramine, desloratadine etc or throughout the desensitization phase of the study.
- Patients who had an acute allergic reaction to food other than peanut, drugs, or stinging insects one month prior to the recruitment clinic visit
- Patients who have had a respiratory infection one month prior to the recruitment clinic visit.
- Patients with significant or uncontrolled asthma, (inhaled corticosteroids (fluticasone >500 mcg per day, ciclesonide >400 mcg per day or budesonide >800 mcg per day or the corresponding combination inhalers, oral prednisone in the preceding 1 month and FEV1 < 80% predicted). Nasal steroids, bronchodilators and leukotriene inhibitors will be permitted. If Prednisone is taken, it must also be stopped 1 month prior to blood being drawn if possible.
- Patients who received allergy injections (immunotherapy) to environmental allergens at any time in the past. Symptomatic atopic dermatitis or chronic urticaria which may interfere with ability to evaluate oral immunotherapy and /or requiring daily medication including antihistamines.
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 |
|---|---|---|
| Peanut proteinAlso: Old Birginia Byrd Mill 12% Lightly Roasted Peanut Flour500 mg | Procedure or surgery | Oral Immunotherapy with H1 and H2 antihistamines, Oral Immunotherapy with placebo antihistamines |
| Oat flour500 mg Oat flour | Procedure or surgery | Double Placebo |
| AntihistamineAlso: Desloratadine and RanitidineDesloratidine 5 ml po od (0.5mg/ml = 2.5 mg) Ranitidine 5ml (15mg/ml=75 mg) po bid | Drug | Oral Immunotherapy with H1 and H2 antihistamines |
Primary outcome
Adverse effects
Time frame: 6-12 months
Frequency and risk of adverse events, overall and stratified by organ system and severity
2 secondary outcomes
Health related quality of life pre and post intervention
Time frame: 6-12 months
Eliciting doses to oral food challenge
Time frame: 6-12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
Related trials for Peanut Allergy
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Efficacy of Tezepelumab in Peanut Oral Immunotherapy
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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, ME principal investigator
McMaster University
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 Phase 2 study testing Peanut protein, Oat flour and Antihistamine in people with Peanut Allergy, run by Hamilton Health Sciences Corporation 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 2 Feb 2022. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adverse effects (time frame: 6-12 months). 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 2 Feb 2022.