Status:
TERMINATED
The Safety and Efficacy of a Peanut Immunotherapy Dissolving Film for Peanut Allergy
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Icahn School of Medicine at Mount Sinai
Conditions:
Peanut Allergy
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine if a new method of administration of peanut sublingual immunotherapy, a dissolving peanut film, is effective.
Detailed Description
Peanut allergy is a common problem with no current treatment. Recent studies have shown some success with oral or sublingual immunotherapy for the treatment of food allergy. Oral treatment, which requ...
Eligibility Criteria
Inclusion
- Age 18 to 50 years
- Provide signed informed consent
- Using appropriate birth control if subject is female and of child bearing age
- Are available for the study duration
- Healthy Volunteers Only
- Regularly consume a meal sized portion (5 grams) of peanut at least twice per month during the proceeding 6 months
- Peanut Allergic Subjects Only
- Have a history of symptomatic reactivity to peanut
- Have a positive skin prick test
- Have a positive oral food challenge to peanut at a cumulative dose of less than 1 grams of peanut protein
- Have self-injectable epinephrine available at home
Exclusion
- Have a history of severe anaphylaxis to peanut, defined as hypoxia, hypotension or neurological compromise as a result of ingestion of peanut.
- Have a history of intubation related to asthma
- Are pregnant or lactating
- Have a viral Upper Respiratory Infection (URI) or gastroenteritis within 7 days of Oral food challenge
- Have pulmonary function tests \<80% of predicted (FEV1) or clinical history consistent with more than moderate persistent asthma
- Are currently taking greater than medium dose inhaled corticosteroid (\>500 mcg/day fluticasone or fluticasone equivalent)
- Are unable to discontinue antihistamines for 5 days for long acting and 3 days for short acting prior to skin testing or food challenges
- Have used systemic corticosteroids within 4 weeks prior to baseline visit
- Are receiving omalizumab, beta-blocker, Angiotensin Converting Enzyme (ACE) inhibitor or tricyclic antidepressant therapy. Subjects need to be off omalizumab for 6 months.
- Have history of oral cancer.
- Use oral tobacco (i.e., chew tobacco)
- Have a chronic disease (other than asthma, atopic dermatitis or rhinitis) requiring therapy (e.g., heart disease, diabetes)
- Have participated in any interventional study for treatment of a food allergy in the past 12 months
- Have a history of eosinophilic esophagitis
- Have a severe reaction at initial double blind placebo-controlled food challenge, defined as either:
- Life-threatening anaphylaxis, or
- Reaction requiring hospitalization
- Healthy Volunteers Only
- History of any allergy to peanut
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 3 2013
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01897077
Start Date
November 1 2012
End Date
February 3 2013
Last Update
July 3 2018
Active Locations (2)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
2
Mount Sinai School of Medicine
New York, New York, United States, 10029