Clinical trial NCT01897077: The Safety and Efficacy of a Peanut Immunotherapy Dissolving Film for Peanut Allergy
Official title: The Safety and Efficacy of a Peanut Immunotherapy Dissolving Film for Peanut Allergy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Peanut Allergy
Keywords: Food Allergy
Peanut
Sublingual Immunotherapy
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Icahn School of Medicine at Mount Sinai
First posted: 2013-07-11
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 requires very high doses, is associated with a small but appreciable risk of systemic reactions. Sublingual immunotherapy, which utilizes much smaller doses, is safer but constraints inherent in the available methods of sublingual administration have limited the utility of this method. Typically sublingual immunotherapy for food allergy has used either fresh foods or a simple liquid extract. These methods are not optimized for practicality or dwell duration in the mouth, and, thus far, dosing has been limited by the ability to make concentrated extracts and by the volume of extract that can be applied to the sublingual space. This study is being conducted to determine if a dissolving peanut extract film, will improve efficacy for immunotherapy for peanut allergy.

Eligibility 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

Primary outcomes:
measure: The Proportion of Subjects That Discontinue the Study for Treatment Related Reasons
timeFrame: 18 months
Secondary outcomes:
measure: The Proportion of Subjects Who Are Able to Tolerate the Full 10 Gram Peanut Protein Challenge at the Completion of the Study
timeFrame: 18 months
measure: Number of Participants With Serious and Non-serious Adverse Effects With Therapy
timeFrame: 18 months
measure: The Rate of Medication Use With Therapy
timeFrame: 18 months
measure: Changes in Biomarkers (Peanut Specific Immunoglobulin E (IgE) and Immunoglobulin G (IgG), Basophil Reactivity, and Salivary Biomarkers) From Baseline to the End of Therapy
timeFrame: 18 months
measure: Number of Participants With Serious Adverse Events With Dosing
timeFrame: 18 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
Study officials:
affiliation: Johns Hopkins University
name: Robert Wood, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Corinne Keet, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Hugh Sampson, MD
role: PRINCIPAL_INVESTIGATOR
References: