Reduction of IgE Antibody in Human Allergic Subjects

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Paul Greenberger, Northwestern University
ClinicalTrials.gov Identifier:
NCT01280149
First received: January 18, 2011
Last updated: April 9, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Seasonal Allergic Rhinitis
Biological: substance P
Biological: substance P injections subcutaneously
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • CBER ID50 skin test result [ Time Frame: 1 to 6 months after completing injections ] [ Designated as safety issue: No ]
    The ID50 skin test result utilizes FDA CBER methodology to determine the change in allergic skin reactivity to ragweed and grass pollen allergens.


Estimated Enrollment: 60
Study Start Date: January 2011
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: substance P-low dose allergen Biological: substance P
injections subcutaneously of substance P and low dose allergen or placebo
Biological: substance P injections subcutaneously
injections of substance P for 8 weeks
Experimental: substance P-moderate dose allergen Biological: substance P
injections subcutaneously of substance P and low dose allergen or placebo
Biological: substance P injections subcutaneously
injections of substance P for 8 weeks
Experimental: substance P-low/moderate dose allergen Biological: substance P
injections subcutaneously of substance P and low dose allergen or placebo
Biological: substance P injections subcutaneously
injections of substance P for 8 weeks
Experimental: substance P-placebo Biological: substance P
injections subcutaneously of substance P and low dose allergen or placebo
Biological: substance P injections subcutaneously
injections of substance P for 8 weeks
Experimental: placebo-low dose allergen Biological: substance P
injections subcutaneously of substance P and low dose allergen or placebo
Biological: substance P injections subcutaneously
injections of substance P for 8 weeks
Placebo Comparator: placebo-placebo Biological: substance P
injections subcutaneously of substance P and low dose allergen or placebo
Biological: substance P injections subcutaneously
injections of substance P for 8 weeks

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01280149

Locations
United States, Illinois
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Paul A Greenberger, M.D. Northwestern University Feinberg School of Medicine
  More Information

No publications provided

Responsible Party: Paul Greenberger, Professor of Medicine, Northwestern University
ClinicalTrials.gov Identifier: NCT01280149     History of Changes
Other Study ID Numbers: BB-IND 4458
Study First Received: January 18, 2011
Last Updated: April 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Northwestern University:
substance P
allergic rhinitis
allergen immunotherapy

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Substance P
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 15, 2014