Reduction of IgE Antibody in Human Allergic Subjects

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.

Study Overview

• Status: Completed
• Conditions: Seasonal Allergic Rhinitis
• Intervention / Treatment: Biological: substance P; Biological: substance P injections

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Feinberg School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Paul A Greenberger, M.D., Northwestern University Feinberg School of Medicine

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): June 20, 2017
• Study Completion (Actual): June 20, 2017

Study Registration Dates

• First Submitted: January 18, 2011
• First Submitted That Met QC Criteria: January 18, 2011
• First Posted (Estimate): January 20, 2011

Study Record Updates

• Last Update Posted (Actual): August 21, 2018
• Last Update Submitted That Met QC Criteria: August 20, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: allergic rhinitis; allergen immunotherapy; substance P
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Substance P; Neurokinin A
• Other Study ID Numbers: BB-IND 4458

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No