Reduction of IgE Antibody in Human Allergic Subjects
This study is enrolling participants by invitation only.
Sponsor:
Northwestern University
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
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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 June 17, 2013