Reduction of IgE Antibody in Human Allergic Subjects

Northwestern University

Status and phase: Completed; Phase 1

Conditions: Seasonal Allergic Rhinitis

Treatments: Biological: substance P; Biological: substance P injections

Study type: Interventional

Funder types: Other

Identifiers

NCT01280149

BB-IND 4458

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 6 patient groups, including a placebo group

substance P-low dose allergen

Experimental group

Description:

Substance P injections with 8 sequential, increasing doses of allergen

Treatment:

Biological: substance P

Biological: substance P injections

substance P-moderate dose allergen

Experimental group

Description:

Substance P with sequential, increasing doses of allergen

Treatment:

Biological: substance P

Biological: substance P injections

substance P-low/moderate dose allergen

Experimental group

Description:

substance P with 16 sequential increasing doses of allergen

Treatment:

Biological: substance P

Biological: substance P injections

substance P-placebo

Active Comparator group

Description:

Placebo injections of substance P and placebo

Treatment:

Biological: substance P

Biological: substance P injections

placebo-low dose allergen

Experimental group

Description:

Placebo injections with 8 sequential increasing low dose allergen injections

Treatment:

Biological: substance P

Biological: substance P injections

placebo-placebo

Placebo Comparator group

Description:

substance P placebo and allergen placebo (weekly)

Treatment:

Biological: substance P

Biological: substance P injections