Topical ASP-1001 (Contrast Media Formulation) and the Acute Response to Nasal Allergen Challenge (NAC)

University of Chicago20 enrolled

Overview

The purpose of this study is to see whether ASP-1001 when given as a nasal spray is safe and can reduce the signs and symptoms of allergic rhinitis (hayfever) following nasal challenge with antigen.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Allergic Rhinitis

Interventions

ASP-1001 nasal sprayDRUG

2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.

Placebo for ASP-1001DRUG

2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.

Eligibility

Sex: ALLMin age: 18 DaysMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Males and females between 18 and 55 years of age. 2. History of grass and/or ragweed allergic rhinitis. 3. Positive skin test to grass and/or ragweed antigen. 4. Positive response to screening nasal challenge. Exclusion Criteria: 1. Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease. 2. Pregnant or lactating women. 3. Upper respiratory infection or sinusitis within 14 days of study start. 4. Use of nasal steroids, antihistamines in the last 2 weeks. 5. FEV1\<80% of predicted at screening for subjects with history of mild asthma 6. current smokers or recent ex-smokers 7. Any social or medical condition that, in the opinion of the investigator, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Locations (1)

University of Chicago Medical Center

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Change in Sneezing Symptom

Sneezes. The change is calculated by adding the number of sneezes following both antigen challenges minus twice the number of sneezes after the diluent challenge.

Time frame: 10 minutes after diluent challenge and 10 minutes after each antigen challenge

Change in Runny Nose Symptom

The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of runny nose following both antigen challenges minus twice the score of runny nose after the diluent challenge.

Time frame: 10 minutes after diluent challenge and 10 minutes after each antigen challenge

Change in Stuffy Nose Symptom

The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of stuffy nose following both antigen challenges minus twice the score of stuffy nose after the diluent challenge.

Time frame: 10 minutes after diluent challenge and 10 minutes after each antigen challenge

Change in Itching Symptom

The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of itchy nose following both antigen challenges minus twice the score of itchy nose after the diluent challenge.

Time frame: 10 minutes after diluent challenge and 10 minutes after each antigen challenge

Secondary Outcomes

Nasal Peak Inspiratory Flow Measurements

The value of nasal peak inspiratory flow. The change is calculated by adding the values of nasal peak inspiratory flow following both antigen challenges minus twice the value of nasal peak inspiratory flow after the diluent challenge.

Time frame: 15 minutes after diluent challenge and 15 minutes after each antigen challenge

Data from ClinicalTrials.gov

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