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

NCT ID: NCT00891436

Last Updated: 2012-12-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2009-08-31

Brief Summary

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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

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Conditions

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Allergic Conjunctivitis to Tree Pollen or Grass Pollen

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo nasal spray

Group Type PLACEBO_COMPARATOR

Placebo nasal spray

Intervention Type DRUG

2 sprays each nostril every morning for 2 weeks

Fluticasone furoate nasal spray

Group Type ACTIVE_COMPARATOR

Fluticasone furoate nasal spray

Intervention Type DRUG

2 sprays each nostril every morning for 2 weeks

Interventions

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Fluticasone furoate nasal spray

2 sprays each nostril every morning for 2 weeks

Intervention Type DRUG

Placebo nasal spray

2 sprays each nostril every morning for 2 weeks

Intervention Type DRUG

Other Intervention Names

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Veramyst

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Rush University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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James Moy

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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J. Moy, MD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Locations

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Rush University Medical Center

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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RUMCgsk 113002

Identifier Type: -

Identifier Source: org_study_id