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Completed

NCT Number: NCT00891436

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

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.

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Key information

Conditions

Allergic Conjunctivitis to Tree Pollen or Grass Pollen

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluticasone furoate nasal spray

Drug

2 sprays each nostril every morning for 2 weeks

Other names: Veramyst

Placebo nasal spray

Drug

2 sprays each nostril every morning for 2 weeks

Primary outcomes

  1. Eosinophilic Cationic Protein (ECP) Levels

    Time frame: 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 outcomes

  1. Histamine Content in the Tears Was Measured.

    Time frame: Samples taken at initial visit & 2 week follow-up

    Tear samples were assayed for histamine by ELISA

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
May 1, 2009
Registry last updated
Dec 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.