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Reduction of IgE Antibody in Human Allergic Subjects

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Northwestern University

Status and phase

Completed
Phase 1

Conditions

Seasonal Allergic Rhinitis

Treatments

Biological: substance P
Biological: substance P injections

Study type

Interventional

Funder types

Other

Identifiers

NCT01280149
BB-IND 4458

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 6 patient groups, including a placebo group

substance P-low dose allergen
Experimental group
Description:
Substance P injections with 8 sequential, increasing doses of allergen
Treatment:
Biological: substance P
Biological: substance P injections
substance P-moderate dose allergen
Experimental group
Description:
Substance P with sequential, increasing doses of allergen
Treatment:
Biological: substance P
Biological: substance P injections
substance P-low/moderate dose allergen
Experimental group
Description:
substance P with 16 sequential increasing doses of allergen
Treatment:
Biological: substance P
Biological: substance P injections
substance P-placebo
Active Comparator group
Description:
Placebo injections of substance P and placebo
Treatment:
Biological: substance P
Biological: substance P injections
placebo-low dose allergen
Experimental group
Description:
Placebo injections with 8 sequential increasing low dose allergen injections
Treatment:
Biological: substance P
Biological: substance P injections
placebo-placebo
Placebo Comparator group
Description:
substance P placebo and allergen placebo (weekly)
Treatment:
Biological: substance P
Biological: substance P injections

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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