Effect of Nasaleze on Nasal Challenge With Allergen

The University of Chicago

Status: Terminated

Conditions: Allergic Rhinitis

Treatments: Biological: Allergen; Other: Placebo spray; Drug: Nasaleze Spray

Study type: Interventional

Funder types: Other

Identifiers

NCT01723397

12-1252

Details and patient eligibility

About

The objectives of this protocol are:

1. to confirm the inhibitory effect of Nasaleze on the immediate response to nasal challenge with antigen, and
2. to show that inhibition of the immediate response to nasal challenge with antigen by Nasaleze inhibits subsequent inflammatory events.

Enrollment: 14 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. Males and females between 18 and 45 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 within 14 days of study start.
4. FEV1<80% of predicted at screening for subjects with history of mild asthma.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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14 participants in 2 patient groups, including a placebo group

Nasaleze spray

Active Comparator group

Description:

Nasaleze spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen challenge

Treatment:

Biological: Allergen

Drug: Nasaleze Spray

Placebo spray

Placebo Comparator group

Description:

Placebo spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen challenge

Treatment:

Other: Placebo spray

Biological: Allergen