Intranasal Steroids and the Nasal Ocular Response

Seasonal Allergic Rhinitis Clinical Trial

Official title:

Intranasal Steroids Prevent Antigen-Induced Hyperresponsiveness of the Nasal Ocular Response

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00473915
• Other study ID #: 15061B
• Status: Completed
• Phase: Phase 4
• First received: May 14, 2007
• Last updated: May 30, 2013
• Start date: April 2007
• Est. completion date: February 2008

Study information

• Verified date: May 2013
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Eye symptoms of tearing, redness and itch frequently occur in patients with allergic rhinitis or hayfever. The purpose of this study is to learn whether placing allergen (the substance that causes allergies) in the nose several days in a row will cause an increase in eye symptoms and whether receiving a nasal steroid spray will prevent these eye symptoms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Drug:
• fluticasone furoate
corticosteroid nasal spray

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in ocular symptoms		between days 1 and 3	No
Secondary	number of eosinophils		between days 1 and 3	No