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Boiled Peanut Oral Immunotherapy for the Treatment of Peanut Allergy: a Pilot Study (BOPI-1)

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ClinicalTrials.gov Identifier: NCT02149719
Recruitment Status : Active, not recruiting
First Posted : May 29, 2014
Last Update Posted : July 23, 2018
Sponsor:
Collaborators:
University of Sydney
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Paul Turner, Imperial College London

Brief Summary:

Peanut allergy is increasingly common, especially in countries such as UK and Australia. There is currently no accepted routine clinical therapy to cure peanut allergy. Recently studies have looked at desensitising people with peanut allergy by giving them small daily doses of roasted peanut. Although this therapy works for some people, its effects are not generally long lasting and it is associated with many side effects during protocol, resulting in a significant rate of drop-outs.

Pilot data suggests that boiled peanut is less immunogenic than roasted peanut, and may therefore provide a safer way of inducing desensitisation in patients who are allergic to roasted peanut, by first inducing tolerance to boiled peanut.

Study hypothesis: Increasing doses of boiled peanut can induce desensitisation to roasted peanut, in peanut-allergic individuals.


Condition or disease Intervention/treatment Phase
IgE Mediated Peanut Allergy Other: Desensitisation using boiled peanut Other: Desensitisation using boiled peanut (deferred start) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Randomised Study of Oral Immunotherapy Using Boiled Peanut to Induce Desensitisation in Children With Challenge-proven, IgE-mediated Peanut Allergy
Actual Study Start Date : May 2015
Actual Primary Completion Date : April 4, 2017
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Experimental: Desensitisation to peanut
Desensitisation using boiled peanut
Other: Desensitisation using boiled peanut
Experimental: Control
Subjects allocated to the control group will undergo routine care for 12 months, following which they will be offered the active treatment with boiled peanut (as a one-way cross-over intervention).
Other: Desensitisation using boiled peanut (deferred start)



Primary Outcome Measures :
  1. Desensitisation to >1.4g (roasted) peanut protein at food challenge [ Time Frame: 12 months ]
    The proportion of participants who tolerate 1.4g (or more) roasted peanut protein after 12 months of OIT as assessed by DBPCFC, in the active vs control group.


Secondary Outcome Measures :
  1. Change in threshold to roasted peanut after 6 and 12 months of OIT [ Time Frame: 6 and 12 months after study intervention ]
    Relative change in clinical threshold (No observed adverse event level, NOAEL; Lowest observed adverse event level, LOAEL) to roasted peanut at 6 and 12 months.

  2. Sustained unresponsiveness after 4 week cessation of maintenance OIT [ Time Frame: After 1 year of OIT ]
    Rate of sustained unresponsiveness after 4 week cessation of maintenance OIT at 1 year.

  3. Safety [ Time Frame: 12 months ]
    Incidence of adverse allergic events during desensitisation protocol

  4. Quality of life measures [ Time Frame: 6, 12 and 24 months ]
    Quality of Life assessment and how this changes during peanut desensitisation.

  5. Study compliance [ Time Frame: 12 months ]
    Compliance with study protocol

  6. Immunological outcomes [ Time Frame: Pre, 3, 6, and 12 months post start of OIT ]
    Immunological outcome measures pre-, during and post- 12 months of OIT


Other Outcome Measures:
  1. Change in threshold in peanut-allergic subjects found to be tolerant to boiled peanut at baseline [ Time Frame: 12 months ]
    Change in threshold in peanut-allergic subjects found to be tolerant to boiled peanut at baseline, as determined by double-blind, placebo-controlled food challenges pre- and post- desensitisation.



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Ages Eligible for Study:   8 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • IgE-mediated peanut allergy, confirmed at double-blind placebo-controlled food challenge
  • Tolerant to at least 1/4 boiled peanut (boiled for 4 hours) at open food challenge.
  • Informed consent of parent/legal guardian and patient assent

Exclusion Criteria:

  • Allergic to 1/4 boiled peanut at PCFC
  • Tolerates ≥1.4 g roasted peanut protein at entry PCFC
  • Unstable asthma
  • Unwilling or unable to fulfil study requirements
  • Undergoing other forms of immunotherapy (e.g. SCIT or SLIT to aeroallergens)
  • Previous admission to ICU for management of allergic reaction to peanut
  • Clinically significant chronic illness (other than asthma, rhinitis or eczema).
  • Undergoing subcutaneous or sublingual immunotherapy and within the first year of therapy, for respiratory allergy.
  • Subjects receiving anti-IgE therapy, oral immunosupressants, beta-blocker or ACE inhibitor therapy.

Information from the National Library of Medicine

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): NCT02149719


Locations
United Kingdom
Imperial College London / Imperial College Healthcare NHS Trust
London, United Kingdom, W2 1NY
Sponsors and Collaborators
Imperial College London
University of Sydney
National Institute for Health Research, United Kingdom
Investigators
Study Chair: Dianne E Campbell, FRACP PhD The Children's Hospital at Westmead, Australia
Study Director: Sam Mehr, FRACP The Children's Hospital at Westmead, Australia
Principal Investigator: Paul J Turner, FRACP PhD Imperial College London

Responsible Party: Paul Turner, Principal Investigator, Imperial College London
ClinicalTrials.gov Identifier: NCT02149719     History of Changes
Other Study ID Numbers: 15SM2492
ACTRN12614000265673 ( Registry Identifier: Australian New Zealand Clinical Trials Registry )
First Posted: May 29, 2014    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: July 2018

Keywords provided by Paul Turner, Imperial College London:
Peanut allergy
Desensitisation
Safety

Additional relevant MeSH terms:
Hypersensitivity
Peanut Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate