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NCT01280149 Clinical Trial

Reduction of IgE Antibody in Human Allergic Subjects

Seasonal Allergic Rhinitis Clinical Trial

Official title:
Reduction of IgE Antibody in Human Allergic Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01280149
Other study ID # BB-IND 4458
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date January 2011
Est. completion date June 20, 2017

Study information
Verified date August 2018
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date June 20, 2017
Est. primary completion date June 20, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• substance P
injections of substance P and low dose allergen or placebo
• substance P injections
injections of substance P for 8 weeks

Locations
Country Name City State
United States Northwestern University Feinberg School of Medicine Chicago Illinois

Sponsors (1)
Lead Sponsor Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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