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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Food Hypersensitivity, Hypersensitivity, Immediate Hypersensitivity, Peanut Hypersensitivity

In brief

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.

Key facts

Study ID

NCT00580606

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

40

Starts

2007-12-01

Expected to finish

2014-12-01

Last updated by the study team

2019-08-21

Who can join

Age: 12 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Arkansas — Little Rock, Arkansas, United States
• National Jewish Medical and Research Center — Denver, Colorado, United States
• Johns Hopkins University School of Medicine — Baltimore, Maryland, United States
• Mount Sinai School of Medicine — New York, New York, United States
• University of North Carolina — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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