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Reduction of IgE Antibody in Human Allergic Subjects

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ClinicalTrials.gov Identifier: NCT01280149
Recruitment Status : Completed
First Posted : January 20, 2011
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Paul Greenberger, Northwestern University

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.

Condition or disease Intervention/treatment Phase
Seasonal Allergic Rhinitis Biological: substance P Biological: substance P injections Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Reduction of IgE Antibody in Human Allergic Subjects
Study Start Date : January 2011
Actual Primary Completion Date : June 20, 2017
Actual Study Completion Date : June 20, 2017

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




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01280149


Locations
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United States, Illinois
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: Paul A Greenberger, M.D. Northwestern University Feinberg School of Medicine
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Responsible Party: Paul Greenberger, Professor of Medicine, Northwestern University
ClinicalTrials.gov Identifier: NCT01280149    
Other Study ID Numbers: BB-IND 4458
First Posted: January 20, 2011    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
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:
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Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Substance P
Neurokinin A
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs