Reduction of IgE Antibody in Human Allergic Subjects

Reduction of IgE Antibody in Human Allergic Subjects

Sponsors

Lead Sponsor: Northwestern University

Source 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.

Overall Status Completed
Start Date 2011-01-01
Completion Date 2017-06-20
Primary Completion Date 2017-06-20
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
CBER ID50 skin test result 1 to 6 months after completing injections
Enrollment 40
Condition
Intervention

Intervention Type: Biological

Intervention Name: substance P

Description: injections of substance P and low dose allergen or placebo

Intervention Type: Biological

Intervention Name: substance P injections

Description: injections of substance P for 8 weeks

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

65 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Paul A Greenberger, M.D. Principal Investigator Northwestern University Feinberg School of Medicine
Location
Facility: Northwestern University Feinberg School of Medicine
Location Countries

United States

Verification Date

2018-08-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Northwestern University

Investigator Full Name: Paul Greenberger

Investigator Title: Professor of Medicine

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 6
Arm Group

Label: substance P-low dose allergen

Type: Experimental

Description: Substance P injections with 8 sequential, increasing doses of allergen

Label: substance P-moderate dose allergen

Type: Experimental

Description: Substance P with sequential, increasing doses of allergen

Label: substance P-low/moderate dose allergen

Type: Experimental

Description: substance P with 16 sequential increasing doses of allergen

Label: substance P-placebo

Type: Active Comparator

Description: Placebo injections of substance P and placebo

Label: placebo-low dose allergen

Type: Experimental

Description: Placebo injections with 8 sequential increasing low dose allergen injections

Label: placebo-placebo

Type: Placebo Comparator

Description: substance P placebo and allergen placebo (weekly)

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Participant)

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