Reduction of IgE Antibody in Human Allergic Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2017-06-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Seasonal Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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substance P-low dose allergen

Substance P injections with 8 sequential, increasing doses of allergen

Group Type EXPERIMENTAL

substance P

Intervention Type BIOLOGICAL

injections of substance P and low dose allergen or placebo

substance P injections

Intervention Type BIOLOGICAL

injections of substance P for 8 weeks

substance P-moderate dose allergen

Substance P with sequential, increasing doses of allergen

Group Type EXPERIMENTAL

substance P

Intervention Type BIOLOGICAL

injections of substance P and low dose allergen or placebo

substance P injections

Intervention Type BIOLOGICAL

injections of substance P for 8 weeks

substance P-low/moderate dose allergen

substance P with 16 sequential increasing doses of allergen

Group Type EXPERIMENTAL

substance P

Intervention Type BIOLOGICAL

injections of substance P and low dose allergen or placebo

substance P injections

Intervention Type BIOLOGICAL

injections of substance P for 8 weeks

substance P-placebo

Placebo injections of substance P and placebo

Group Type ACTIVE_COMPARATOR

substance P

Intervention Type BIOLOGICAL

injections of substance P and low dose allergen or placebo

substance P injections

Intervention Type BIOLOGICAL

injections of substance P for 8 weeks

placebo-low dose allergen

Placebo injections with 8 sequential increasing low dose allergen injections

Group Type EXPERIMENTAL

substance P

Intervention Type BIOLOGICAL

injections of substance P and low dose allergen or placebo

substance P injections

Intervention Type BIOLOGICAL

injections of substance P for 8 weeks

placebo-placebo

substance P placebo and allergen placebo (weekly)

Group Type PLACEBO_COMPARATOR

substance P

Intervention Type BIOLOGICAL

injections of substance P and low dose allergen or placebo

substance P injections

Intervention Type BIOLOGICAL

injections of substance P for 8 weeks

Interventions

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substance P

injections of substance P and low dose allergen or placebo

Intervention Type BIOLOGICAL

substance P injections

injections of substance P for 8 weeks

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No