Reduction of IgE Antibody in Human Allergic Subjects
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jan 2011
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 18, 2011
CompletedFirst Posted
Study publicly available on registry
January 20, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2017
CompletedAugust 21, 2018
August 1, 2018
6.5 years
January 18, 2011
August 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (6)
substance P-low dose allergen
EXPERIMENTALSubstance P injections with 8 sequential, increasing doses of allergen
substance P-moderate dose allergen
EXPERIMENTALSubstance P with sequential, increasing doses of allergen
substance P-low/moderate dose allergen
EXPERIMENTALsubstance P with 16 sequential increasing doses of allergen
substance P-placebo
ACTIVE COMPARATORPlacebo injections of substance P and placebo
placebo-low dose allergen
EXPERIMENTALPlacebo injections with 8 sequential increasing low dose allergen injections
placebo-placebo
PLACEBO COMPARATORsubstance P placebo and allergen placebo (weekly)
Interventions
injections of substance P and low dose allergen or placebo
injections of substance P for 8 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- volunteer is pregnant or lactating
- abnormal electrocardiogram for subjects over 50 years of age
- use of beta adrenergic antagonists or tricyclic antidepressants
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul A Greenberger, M.D.
Northwestern University Feinberg School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
January 18, 2011
First Posted
January 20, 2011
Study Start
January 1, 2011
Primary Completion
June 20, 2017
Study Completion
June 20, 2017
Last Updated
August 21, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share