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

Primary Purpose

Allergic Conjunctivitis to Tree Pollen or Grass Pollen

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Fluticasone furoate nasal spray
Placebo nasal spray
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Conjunctivitis to Tree Pollen or Grass Pollen

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Rush University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo nasal spray

Fluticasone furoate nasal spray

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Histamine Content in the Tears Was Measured.
Tear samples were assayed for histamine by ELISA

Full Information

First Posted
April 30, 2009
Last Updated
November 29, 2012
Sponsor
Rush University Medical Center
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00891436
Brief Title
Study of the Effect of Fluticasone Furoate Nasal Spray on Spring Allergy Eye Symptoms
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rush University Medical Center
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Conjunctivitis to Tree Pollen or Grass Pollen

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo nasal spray
Arm Type
Placebo Comparator
Arm Title
Fluticasone furoate nasal spray
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Fluticasone furoate nasal spray
Other Intervention Name(s)
Veramyst
Intervention Description
2 sprays each nostril every morning for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo nasal spray
Intervention Description
2 sprays each nostril every morning for 2 weeks
Primary Outcome Measure Information:
Title
Eosinophilic Cationic Protein (ECP) Levels
Description
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.
Time Frame
Samples taken at initial visit & 2 week follow-up
Secondary Outcome Measure Information:
Title
Histamine Content in the Tears Was Measured.
Description
Tear samples were assayed for histamine by ELISA
Time Frame
Samples taken at initial visit & 2 week follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. Moy, MD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

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

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