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

Phase 4

Completed

• Conditions: Allergic Rhinitis
• Interventions: Drug: fluticasone furoate; Drug: Placebo

• Registration Number: NCT00791973
• Lead Sponsor: University of Chicago

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-11-13
• Study First Submitted QC: 2008-11-14
• Study First Posted: 2008-11-17
• Primary Completion: 2009-04
• Study Completion: 2010-05
• Status Verified: 2014-06
• Results First Submitted: 2014-06-06
• Results First Submitted QC: 2014-06-06
• Last Update Submitted: 2014-06-06
• Results First Posted: 2014-07-08
• Last Update Posted: 2014-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Veramyst, then Placebo	Placebo	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
Placebo, then Veramyst	Placebo	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
Veramyst, then Placebo	fluticasone furoate	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
Placebo, then Veramyst	fluticasone furoate	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

Primary Outcome Measures

Name	Time	Method
Change in Tryptase Level From Baseline to Post-antigen Challenge	After one week of treatment wtih veramyst or placebo	Tryptase levels (mcg/L) were measured from nasal lavages

Secondary Outcome Measures

Name	Time	Method
Total Eye Symptom Scores After Antigen Challenge	After one week of treatment wtih veramyst or placebo	Watery and itchy eye symptoms will be scored based on the following scale: 0=no symptoms, 1= mild, 2= moderate, 3= severe

Trial Locations

Locations (1)

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States