The Safety and Efficacy of a Peanut Immunotherapy Dissolving Film for Peanut Allergy

• Status: Terminated
• Trial end date: 2013-02-03
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: Icahn School of Medicine at Mount Sinai

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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