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

Comparison of the Effect of Fluticasone Furoate Nasal Spray Versus Placebo on Allergic Mediators in the Tears of Subjects With Tree or Grass Pollen Allergy

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.

Study Overview

• Status: Completed
• Conditions: Allergic Conjunctivitis to Tree Pollen or Grass Pollen
• Intervention / Treatment: Drug: Placebo nasal spray; Drug: Fluticasone furoate nasal spray

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo nasal spray	Drug: Placebo nasal spray; 2 sprays each nostril every morning for 2 weeks
Active Comparator: Fluticasone furoate nasal spray	Drug: Fluticasone furoate nasal spray; 2 sprays each nostril every morning for 2 weeks; Other Names: Veramyst

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eosinophilic Cationic Protein (ECP) Levels	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.	Samples taken at initial visit & 2 week follow-up

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Collaborators: GlaxoSmithKline
• Investigators: Principal Investigator: J. Moy, MD, Rush University Medical Center

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: April 30, 2009
• First Submitted That Met QC Criteria: April 30, 2009
• First Posted (Estimate): May 1, 2009

Study Record Updates

• Last Update Posted (Estimate): December 3, 2012
• Last Update Submitted That Met QC Criteria: November 29, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Eye Diseases; Hypersensitivity; Conjunctival Diseases; Conjunctivitis; Conjunctivitis, Allergic; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Fluticasone; Xhance
• Other Study ID Numbers: RUMCgsk 113002