Reduction of IgE Antibody in Human Allergic Subjects

Study Overview
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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.

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.

Official Title
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Reduction of IgE Antibody in Human Allergic Subjects

Conditions
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Seasonal Allergic Rhinitis

Intervention / Treatment
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* Biological: substance P
* Biological: substance P injections


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: substance P-low dose allergen<br>Substance P injections with 8 sequential, increasing doses of allergen | Biological: substance P<br>* injections of substance P and low dose allergen or placebo<br>Biological: substance P injections<br>* injections of substance P for 8 weeks<br>|
| Experimental: substance P-moderate dose allergen<br>Substance P with sequential, increasing doses of allergen | Biological: substance P<br>* injections of substance P and low dose allergen or placebo<br>Biological: substance P injections<br>* injections of substance P for 8 weeks<br>|
| Experimental: substance P-low/moderate dose allergen<br>substance P with 16 sequential increasing doses of allergen | Biological: substance P<br>* injections of substance P and low dose allergen or placebo<br>Biological: substance P injections<br>* injections of substance P for 8 weeks<br>|
| Active Comparator: substance P-placebo<br>Placebo injections of substance P and placebo | Biological: substance P<br>* injections of substance P and low dose allergen or placebo<br>Biological: substance P injections<br>* injections of substance P for 8 weeks<br>|
| Experimental: placebo-low dose allergen<br>Placebo injections with 8 sequential increasing low dose allergen injections | Biological: substance P<br>* injections of substance P and low dose allergen or placebo<br>Biological: substance P injections<br>* injections of substance P for 8 weeks<br>|
| Placebo Comparator: placebo-placebo<br>substance P placebo and allergen placebo (weekly) | Biological: substance P<br>* injections of substance P and low dose allergen or placebo<br>Biological: substance P injections<br>* injections of substance P for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 to 6 months after completing injections | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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substance P, allergic rhinitis, allergen immunotherapy