Reduction of IgE Antibody in Human Allergic Subjects

What Was Tested

In this phase 1 trial, researchers set out to test Substance P for seasonal allergies.

It had six arms (groups): one (experimental), one (experimental), one (experimental), substance P-placebo (active comparator) and one (experimental).

The registry classes the interventions as biological.

More on the Plan

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.

Who Took Part

Enrollment: 40 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: volunteer is pregnant or lactating; abnormal electrocardiogram for subjects over 50 years of age; use of beta adrenergic antagonists or tricyclic antidepressants.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

Random assignment meant chance, not the researchers, decided who got Substance P and who got the comparison, which limits bias.

Groups ran in parallel: each of the seasonal allergies participants stayed in one arm throughout.

In this single-blind Substance P study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2011-01 with completion listed for 2017-06-20.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: CBER ID50 skin test result (time frame: 1 to 6 months after completing injections).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Substance P in 40 people with seasonal allergies.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Substance P compound page, Seasonal allergies research.