Seasonal Allergic Rhinitis
Conditions
Keywords
substance P, allergic rhinitis, allergen immunotherapy
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.
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.
Interventions
BIOLOGICALsubstance P
injections of substance P and low dose allergen or placebo
BIOLOGICALsubstance P injections
injections of substance P for 8 weeks
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CBER ID50 skin test result | 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. |
Countries
United States
Outcome results
None listed