Reduction of IgE Antibody in Human Allergic Subjects

Northwestern University40 enrolled

Overview

The purpose of this study is to determine whether a neuropeptide, substance P, when injected along with an allergen, such as ragweed, can reduce allergic reactivity.

Allergic Rhinitis (Hay fever) affects many children and adults and is a risk factor for development of asthma. This study utilizes the neurotransmitter, substance P, a small molecule which is present in nerve endings, the brain, skin, lungs and the gastrointestinal tract. Subjects will receive substance P and a low dosage of an allergen, such as ragweed in an attempt to reduce allergic reactivity.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Seasonal Allergic Rhinitis

Interventions

substance PBIOLOGICAL

injections of substance P and low dose allergen or placebo

substance P injectionsBIOLOGICAL

injections of substance P for 8 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * positive immediate type skin test to ragweed or grass pollen or a third (standardized) allergen if both ragweed and grass pollen allergen are not positive * volunteers should be available for allergen injections and then cutaneous titrations for approximately 1 year from the start of the enrollment period Exclusion Criteria: * volunteer is pregnant or lactating * abnormal electrocardiogram for subjects over 50 years of age * use of beta adrenergic antagonists or tricyclic antidepressants

Locations (1)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

Outcomes

Primary Outcomes

CBER ID50 skin test result

The ID50 skin test result utilizes FDA CBER methodology to determine the change in allergic skin reactivity to ragweed and grass pollen allergens.

Time frame: 1 to 6 months after completing injections

Data from ClinicalTrials.gov

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