Effect of Veramyst on the Nasal and Ocular Symptoms of the Early Reaction to Nasal Challenge With Allergen

The University of Chicago

Status and phase: Completed; Phase 4

Conditions: Allergic Rhinitis

Treatments: Drug: fluticasone furoate; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00791973

16367B (OC 3)

Details and patient eligibility

About

The purpose of this study is to help us to a better understanding of how nose and eye symptoms are related in patients with allergies.

Enrollment: 15 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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15 participants in 2 patient groups

Veramyst, then Placebo

Active Comparator group

Description:

fluticasone furoate (Veramyst) nasal spray once daily for a week, then one week washout period followed by placebo nasal spray once daily for a week

Treatment:

Drug: Placebo

Drug: fluticasone furoate

Placebo, then Veramyst

Active Comparator group

Description:

placebo nasal spray once daily for a week, then one week washout period followed by fluticasone furoate (veramyst) nasal spray once daily for a week

Treatment:

Drug: Placebo

Drug: fluticasone furoate