Trial record 5 of 5 for:    Open Studies | "Nut Hypersensitivity"

Walnut Oral Immunotherapy for Tree Nut Allergy

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by Children's Hospital of Philadelphia
Sponsor:
Collaborator:
University of Arkansas
Information provided by (Responsible Party):
Jonathan Spergel, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01918657
First received: July 22, 2012
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

The purpose of this research study is to learn about the medical effects, safety, and how the Walnut Oral Immunotherapy (OIT) treatment affects your body (immune system). This type of immunotherapy involves giving increasing doses of walnut allergen to gradually build up a person's tolerance to walnut and at least one other tree nut. The goal of the study is to determine whether participants can tolerate (eat) walnuts and at least one other tree nut in their diet after stopping the study therapy.


Condition Intervention Phase
Peanut Allergy
Drug: walnut powder
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Walnut Oral Immunotherapy for Tree Nut Allergy-CHOP

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • effectiveness of walnut immunotherapy on desensitization to test tree nut or reduction in serum specific IgE [ Time Frame: 38 weeks ] [ Designated as safety issue: No ]
    The primary clinical efficacy outcome of the study will be the change from baseline OFC in cumulative dose reached at the desensitization OFC to the test tree nut.


Secondary Outcome Measures:
  • The percentage of subjects who reach a cumulative dose of 5000 mg and 2000 mg at the desensitization OFC to walnut and to the test tree nut (desensitization OFC is at ~38 weeks) [ Time Frame: 38 weeks ] [ Designated as safety issue: No ]
    1.The percentage of subjects who reach a cumulative dose of 5000 mg and 2000 mg at the desensitization OFC to walnut and to the test tree nut (desensitization OFC is at ~38 weeks)

  • The percentage of subjects who reach a cumulative dose of 5000 mg and 2000 mg at the desensitization OFC to walnut and to the test tree nut (desensitization OFC is at ~38 weeks) [ Time Frame: 38 weeks ] [ Designated as safety issue: No ]
    2.The percentage of subjects that demonstrate clinical tolerance at end of study to walnut and to the test tree nut.

  • The percentage of subjects who reach a cumulative dose of 5000 mg and 2000 mg at the desensitization OFC to walnut and to the test tree nut (desensitization OFC is at ~38 weeks) [ Time Frame: 38 weeks ] [ Designated as safety issue: No ]
    3.The change in immune parameters over time including humoral responses, basophil/effector cell responses, and cytokine responses to tree nuts in cultured cells over time.

  • The percentage of subjects who reach a cumulative dose of 5000 mg and 2000 mg at the desensitization OFC to walnut and to the test tree nut (desensitization OFC is at ~38 weeks) [ Time Frame: 38 weeks ] [ Designated as safety issue: Yes ]
    4.Incidence of all serious adverse events during the study


Estimated Enrollment: 6
Study Start Date: February 2014
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: walnut powder
Subjects will be randomized in a 2:1 ratio into either an active treatment group (final dose 1500 mg walnut protein, n=20) or a placebo group (n=10). Subjects will undergo a one-day desensitization protocol designed to enable the subject to tolerate 6 mg of walnut protein or placebo (initial day escalation phase). After the initial escalation day achieving at least 1.5 mg and up to 6 mg of walnut protein or placebo, dosing build-up will occur every two weeks through dose 24 at 34 weeks. A maintenance dose will be given for 4 weeks followed by a 5 gram protein OFC to walnut and a 5 gram protein OFC to a second tree nut (at ~38 weeks), after which the study will be unblinded.
Drug: walnut powder
escalating doses of walnut powder
Placebo Comparator: placebo arm
Subjects will be randomized in a 2:1 ratio into either an active treatment group (final dose 1500 mg walnut protein, n=20) or a placebo group (n=10). Subjects will undergo a one-day desensitization protocol designed to enable the subject to tolerate 6 mg of walnut protein or placebo (initial day escalation phase). After the initial escalation day achieving at least 1.5 mg and up to 6 mg of walnut protein or placebo, dosing build-up will occur every two weeks through dose 24 at 34 weeks. A maintenance dose will be given for 4 weeks followed by a 5 gram protein OFC to walnut and a 5 gram protein OFC to a second tree nut (at ~38 weeks), after which the study will be unblinded. Placebo subjects that fail the OFC will be crossed over to active treatment and escalated as described to the 1500 mg target dose.
Drug: walnut powder
Subjects will be randomized in a 2:1 ratio into either an active treatment group (final dose 1500 mg walnut protein, n=20) or a placebo group (n=10). Subjects will undergo a one-day desensitization protocol designed to enable the subject to tolerate 6 mg of walnut protein or placebo (initial day escalation phase). After the initial escalation day achieving at least 1.5 mg and up to 6 mg of walnut protein or placebo, dosing build-up will occur every two weeks through dose 24 at 34 weeks. A maintenance dose will be given for 4 weeks followed by a 5 gram protein OFC to walnut and a 5 gram protein OFC to a second tree nut (at ~38 weeks), after which the study will be unblinded. Placebo subjects that fail the OFC will be crossed over to active treatment and escalated as described to the 1500 mg target dose.
Other Name: Greer walnut powder-DMF 12828

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 6 to 21 years, either sex, any race, any ethnicity with a convincing clinical history of walnut or another tree nut allergy and either a positive prick skin test (>3mm) or serologic evidence of allergic sensitization (defined as specific IgE>0.35 kU/L) to walnut and at least one other tree.
  • A positive <2000 mg protein oral food challenge at enrollment to walnut and to one other tree nut.
  • Written informed consent from participant and/or parent/guardian, including assent where indicated.
  • All females of child-bearing age must be using appropriate birth control or practicing abstinence.

Exclusion Criteria:

  • History of severe anaphylaxis to walnut or other tree nuts, defined as symptoms associated with hypoxia, hypotension or neurologic compromise (cyanosis or SpO2<92% at any stage, hypotension, confusion, collapse, loss of consciousness; or incontinence).
  • Known allergy to oat
  • Chronic disease (other than asthma, atopic dermatitis, rhinitis) requiring therapy or other respiratory or medical conditions deemed by the investigator to put subject at increased risk of anaphylaxis or poor outcomes from receiving OIT or undergoing food challenge.
  • Poor control or persistent activation of atopic dermatitis
  • Active eosinophilic or other inflammatory (e.g., celiac) gastrointestinal disease in the past 2 years.
  • Participation in any interventional study for food allergy in the past 6 months
  • Participant is on "build-up phase" of immunotherapy (i.e., has not reached maintenance dosing).
  • Severe asthma (2007 NHLBI Criteria Steps 5 or 6, see Appendix 2)
  • Mild or moderate (2007 NHLBI Criteria Steps 1-4) asthma with any of the following criteria met:
  • FEV1 < 80% of predicted, or FEV1/FVC < 75%, with or without controller medications or
  • ICS dosing of > 500 mcg daily fluticasone (or equivalent inhaled corticosteroids based on NHLBI dosing chart) or
  • History of daily oral steroid dosing for > 1 month during the past year or
  • Burst of oral, IM, or IV steroids for >3 days in the past 6 months for asthma control or
  • > 1 burst of oral, IM or IV steroids in the past year for asthma control or
  • > 1 hospitalization in the past year for asthma or
  • > 1 ER visit in the past 6 months for asthma
  • Inability to discontinue antihistamines for initial day escalation, skin testing or OFC
  • Use of omalizumab or other non-traditional forms of allergen immunotherapy (e.g., oral or sublingual) or immunomodulator therapy (not including corticosteroids) or biologic therapy within the past year
  • Use of beta-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB) or calcium channel blockers
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01918657

Contacts
Contact: Jonathan M Spergel, MD, PhD 215-590-2549 spergel@email.chop.edu
Contact: Kathy L Pinzone, RN, CRNC 267-426-2263 pinzone@email.chop.edu

Locations
United States, Pennsylvania
Children's Hospital of Philadelphia Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Jonathan M Spergel, MD, PhD    215-590-2549    spergel@email.chop.edu   
Contact: Kathy L Pinzone, RN, CRNC    267-426-2262    pinzone@email.chop.edu   
Principal Investigator: Jonathan M Spergel, MD, PhD         
Sub-Investigator: Terri F Brown-Whitehorn, MD         
Sub-Investigator: Rushani Saltzman, MD         
Sub-Investigator: Megan Ott, MSN, RN, CPNP         
Sponsors and Collaborators
Jonathan Spergel
University of Arkansas
Investigators
Principal Investigator: Jonathan M Spergel, MD, PhD Children's Hospital of Philadelphia
  More Information

No publications provided

Responsible Party: Jonathan Spergel, MD, PhD, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01918657     History of Changes
Other Study ID Numbers: 12-009443
Study First Received: July 22, 2012
Last Updated: February 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Hospital of Philadelphia:
Interventional
Randomized
Double blind
Placebo controlled
Pediatric

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

ClinicalTrials.gov processed this record on August 01, 2014