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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| substance P-low dose allergen | Experimental | Substance P injections with 8 sequential, increasing doses of allergen |
|
| substance P-moderate dose allergen | Experimental | Substance P with sequential, increasing doses of allergen |
|
| substance P-low/moderate dose allergen | Experimental | substance P with 16 sequential increasing doses of allergen |
|
| substance P-placebo | Active Comparator | Placebo injections of substance P and placebo |
|
| placebo-low dose allergen | Experimental | Placebo injections with 8 sequential increasing low dose allergen injections |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| substance P | Biological | injections of substance P and low dose allergen or placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul A Greenberger, M.D. | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
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| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| ID | Term |
|---|---|
| D013373 | Substance P |
| ID | Term |
|---|---|
| D015320 | Tachykinins |
| D007705 | Kinins |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
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| placebo-placebo |
| Placebo Comparator |
substance P placebo and allergen placebo (weekly) |
|
| substance P injections | Biological | injections of substance P for 8 weeks |
|
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D009479 | Neuropeptides |
| D009842 | Oligopeptides |
| D011506 | Proteins |
| D009419 | Nerve Tissue Proteins |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |