Reduction of IgE Antibody in Human Allergic Subjects

Phase 1

Completed

• Conditions: Seasonal Allergic Rhinitis
• Interventions: Biological: substance P; Biological: substance P injections

• Registration Number: NCT01280149
• Lead Sponsor: Northwestern University

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-18
• Study First Submitted QC: 2011-01-18
• Study First Posted: 2011-01-20
• Primary Completion: 2017-06-20
• Study Completion: 2017-06-20
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-20
• Last Update Posted: 2018-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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Exclusion Criteria

• volunteer is pregnant or lactating
• abnormal electrocardiogram for subjects over 50 years of age
• use of beta adrenergic antagonists or tricyclic antidepressants

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
substance P-low dose allergen	substance P	Substance P injections with 8 sequential, increasing doses of allergen
substance P-low dose allergen	substance P injections	Substance P injections with 8 sequential, increasing doses of allergen
substance P-moderate dose allergen	substance P	Substance P with sequential, increasing doses of allergen
substance P-low/moderate dose allergen	substance P injections	substance P with 16 sequential increasing doses of allergen
substance P-placebo	substance P	Placebo injections of substance P and placebo
placebo-low dose allergen	substance P	Placebo injections with 8 sequential increasing low dose allergen injections
placebo-low dose allergen	substance P injections	Placebo injections with 8 sequential increasing low dose allergen injections
substance P-moderate dose allergen	substance P injections	Substance P with sequential, increasing doses of allergen
substance P-placebo	substance P injections	Placebo injections of substance P and placebo
substance P-low/moderate dose allergen	substance P	substance P with 16 sequential increasing doses of allergen
placebo-placebo	substance P	substance P placebo and allergen placebo (weekly)
placebo-placebo	substance P injections	substance P placebo and allergen placebo (weekly)

Primary Outcome Measures

Name	Time	Method
CBER ID50 skin test result	1 to 6 months after completing injections	The ID50 skin test result utilizes FDA CBER methodology to determine the change in allergic skin reactivity to ragweed and grass pollen allergens.

Trial Locations

Locations (1)

Northwestern University Feinberg School of Medicine; 🇺🇸 Chicago, Illinois, United States