Study of the Effect of Fluticasone Furoate Nasal Spray on Spring Allergy Eye Symptoms

Phase 4

Completed

• Conditions: Allergic Conjunctivitis to Tree Pollen or Grass Pollen
• Interventions: Drug: Placebo nasal spray; Drug: Fluticasone furoate nasal spray

• Registration Number: NCT00891436
• Lead Sponsor: Rush University Medical Center

Brief Summary

Rationale and objectives:

Fluticasone furoate nasal spray (Veramyst) has been shown to improve ocular symptoms when used for the treatment of seasonal allergic rhinitis during the ragweed pollen season. Although this is the only published report of an intranasal corticosteroid shown to effectively treat ocular symptoms, the mechanism has not been delineated. Furthermore, the tears of patients with allergic conjunctivitis are known to have increased concentrations of cytokines and allergic mediators.

The objective of this study is to determine if the positive effects of Veramyst nasal spray on ocular symptoms is via the inhibition of allergic mediators in the eyes. The investigators will conduct a double blind placebo controlled trial to determine if Veramyst nasal spray decreases the amount of allergic mediators in the tears of subjects randomized to Veramyst nasal spray versus placebo. The investigators will also compare the subjects' symptoms to the amount of allergic mediators detected in their tears.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-30
• Study First Submitted QC: 2009-04-30
• Study First Posted: 2009-05-01
• Primary Completion: 2009-07
• Study Completion: 2009-08
• Results First Submitted: 2012-09-14
• Results First Submitted QC: 2012-09-14
• Results First Posted: 2012-10-18
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-29
• Last Update Posted: 2012-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• a documented history of allergic rhinitis and conjunctivitis due to tree pollen and / or grass pollen for two allergy seasons
• positive skin prick test to tree and / or grass

Exclusion Criteria

• glaucoma
• cataracts
• acute or chronic sinusitis
• asthma
• chronic obstructive pulmonary disease
• physical nasal obstruction
• pregnant or breastfeeding
• have had a viral or bacterial infections within 2 weeks of the study commencement
• receiving allergen immunotherapy
• have used inhaled corticosteroids within 14 days prior to the study
• have used systemic corticosteroids within 30 days of the study
• travel outside of the geographic area during the 2 week study period
• use of contact lenses during the study period
• use of artificial tears during the study period
• use of eyewash irrigation during the study period
• use of lubricants during the study period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo nasal spray	Placebo nasal spray	-
Fluticasone furoate nasal spray	Fluticasone furoate nasal spray	-

Primary Outcome Measures

Name	Time	Method
Eosinophilic Cationic Protein (ECP) Levels	Samples taken at initial visit & 2 week follow-up	Tear samples from the participants eyes were collect and were to be used for measuring esinophilic cationic prtein, but this was not measured because the volume of tears were to low.

Secondary Outcome Measures

Name	Time	Method
Histamine Content in the Tears Was Measured.	Samples taken at initial visit & 2 week follow-up	Tear samples were assayed for histamine by ELISA

Trial Locations

Locations (1)

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