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Reduction of IgE Antibody in Human Allergic Subjects

Primary Purpose

Seasonal Allergic Rhinitis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

substance P

substance P injections

About this trial

This is an interventional treatment trial for Seasonal Allergic Rhinitis focused on measuring substance P, allergic rhinitis, allergen immunotherapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Northwestern University Feinberg School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Experimental

Placebo Comparator

Arm Label

substance P-low dose allergen

substance P-moderate dose allergen

substance P-low/moderate dose allergen

substance P-placebo

placebo-low dose allergen

placebo-placebo

Arm Description

Substance P injections with 8 sequential, increasing doses of allergen

Substance P with sequential, increasing doses of allergen

substance P with 16 sequential increasing doses of allergen

Placebo injections of substance P and placebo

Placebo injections with 8 sequential increasing low dose allergen injections

substance P placebo and allergen placebo (weekly)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01280149

First Posted

January 18, 2011

Last Updated

August 20, 2018

Sponsor

Northwestern University

1. Study Identification

Unique Protocol Identification Number

NCT01280149

Brief Title

Reduction of IgE Antibody in Human Allergic Subjects

Official Title

Reduction of IgE Antibody in Human Allergic Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

June 20, 2017 (Actual)

Study Completion Date

June 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Seasonal Allergic Rhinitis

Keywords

substance P, allergic rhinitis, allergen immunotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

substance P-low dose allergen

Arm Type

Experimental

Arm Description

Substance P injections with 8 sequential, increasing doses of allergen

Arm Title

substance P-moderate dose allergen

Arm Type

Experimental

Arm Description

Substance P with sequential, increasing doses of allergen

Arm Title

substance P-low/moderate dose allergen

Arm Type

Experimental

Arm Description

substance P with 16 sequential increasing doses of allergen

Arm Title

substance P-placebo

Arm Type

Active Comparator

Arm Description

Placebo injections of substance P and placebo

Arm Title

placebo-low dose allergen

Arm Type

Experimental

Arm Description

Placebo injections with 8 sequential increasing low dose allergen injections

Arm Title

placebo-placebo

Arm Type

Placebo Comparator

Arm Description

substance P placebo and allergen placebo (weekly)

Intervention Type

Biological

Intervention Name(s)

substance P

Intervention Description

injections of substance P and low dose allergen or placebo

Intervention Type

Biological

Intervention Name(s)

substance P injections

Intervention Description

injections of substance P for 8 weeks

Primary Outcome Measure Information:

Title

CBER ID50 skin test result

Description

The ID50 skin test result utilizes FDA CBER methodology to determine the change in allergic skin reactivity to ragweed and grass pollen allergens.

Time Frame

1 to 6 months after completing injections

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul A Greenberger, M.D.

Organizational Affiliation

Northwestern University Feinberg School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northwestern University Feinberg School of Medicine

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Reduction of IgE Antibody in Human Allergic Subjects

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