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

Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00791973
• Other study ID #: 16367B (OC 3)
• Status: Completed
• Phase: Phase 4
• First received: November 13, 2008
• Last updated: June 6, 2014
• Start date: November 2008
• Est. completion date: May 2010

Study information

• Verified date: June 2014
• 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 2010
• Est. primary completion date: April 2009
• 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, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis

Intervention

Drug:
• fluticasone furoate
2 puffs in each nostril once daily for 1 week
• Placebo
2 puffs in each nostril once daily for 1 week

Locations

Country	Name	City	State
United States	University of Chicago Medical Center	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 Tryptase Level From Baseline to Post-antigen Challenge	Tryptase levels (mcg/L) were measured from nasal lavages	After one week of treatment wtih veramyst or placebo	No
Secondary	Total Eye Symptom Scores After Antigen Challenge	Watery and itchy eye symptoms will be scored based on the following scale: 0=no symptoms, 1= mild, 2= moderate, 3= severe	After one week of treatment wtih veramyst or placebo	No