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Reduction of IgE Antibody in Human Allergic Subjects

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Paul Greenberger, Northwestern University
ClinicalTrials.gov Identifier:
NCT01280149
First received: January 18, 2011
Last updated: April 5, 2017
Last verified: April 2017
  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 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant
Primary Purpose: Treatment
Official Title: Reduction of IgE Antibody in Human Allergic Subjects

Further study details as provided by Paul Greenberger, Northwestern University:

Primary Outcome Measures:
  • CBER ID50 skin test result [ Time Frame: 1 to 6 months after completing injections ]
    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 Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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   (Adult)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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 5, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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

ClinicalTrials.gov processed this record on July 21, 2017