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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
James Moy, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT00891436
First received: April 30, 2009
Last updated: November 29, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Allergic Conjunctivitis to Tree Pollen or Grass Pollen
 Drug: Fluticasone furoate nasal spray
Drug: Placebo nasal spray
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • Eosinophilic Cationic Protein (ECP) Levels [ Time Frame: Samples taken at initial visit & 2 week follow-up ] [ Designated as safety issue: No ]
    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. [ Time Frame: Samples taken at initial visit & 2 week follow-up ] [ Designated as safety issue: No ]
    Tear samples were assayed for histamine by ELISA


Enrollment: 20
Study Start Date: April 2009
Study Completion Date: August 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Veramyst

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00891436

Locations
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
GlaxoSmithKline
Investigators
Principal Investigator: J. Moy, MD Rush University Medical Center
  More Information

No publications provided

Responsible Party: James Moy, MD, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT00891436     History of Changes
Other Study ID Numbers: RUMCgsk 113002
Study First Received: April 30, 2009
Results First Received: September 14, 2012
Last Updated: November 29, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Bronchodilator Agents
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 16, 2013