A Randomized, Double-Blind Placebo-Controlled Peanut Sublingual Immunotherapy Trial

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and immune response to daily sublingual (under the tongue) immunotherapy (SLIT) with peanut extract in adults and children with peanut allergies.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Consortium of Food Allergy Research
• Treatments: Glycerol

Criteria

Inclusion Criteria:

• Physician-diagnosed peanut allergy OR convincing clinical history of peanut allergy

• Reacts to a cumulative dose of 2,000 mg or less of peanut powder

• Positive peanut allergy skin prick test OR detectable serum peanut-specific IgE level

• Willing to use an acceptable method of contraception for the duration of the study

• Ability to perform spirometry maneuver in accordance with the American Thoracic Society guidelines

Exclusion Criteria:

• History of severe anaphylaxis to peanut

• Currently participating in a study using a new investigational new drug

• Participation in any interventional study for the treatment of food allergy in the 12 months prior to study entry

• Allergic to placebo ingredients (glycerin or oat flour) OR reacts to any dose of placebo during study entry oral food challenge (OFC)

• Currently in a buildup phase of any allergy immunotherapy

• Poor control of atopic dermatitis

• Moderate or severe asthma despite therapy

• Current treatment with greater than medium daily doses of inhaled corticosteroids

• Use of steroid medications

• Use of omalizumab or other nontraditional forms of allergen immunomodulatory therapy (not including corticosteroids) or biologic therapy in the 12 months prior to study entry

• Use of beta blockers, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, or calcium channel blockers

• Inability to discontinue antihistamines for skin testing and OFCs

• History of ischemic cardiovascular disease

• History of alcohol or drug abuse

• Other significant medical conditions that, in the opinion of the investigator, prevent participation in the study

• Previous intubation due to allergies or asthma

• Uncontrolled high blood pressure

• Pregnancy or breastfeeding