Study of the Effect of Fluticasone Furoate Nasal Spray on Spring Allergy Eye Symptoms - Full Text View

Sponsors and Collaborators:	Rush University Medical Center GlaxoSmithKline
Information provided by:	Rush University Medical Center
ClinicalTrials.gov Identifier:	NCT00891436

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 IV

MedlinePlus related topics: Allergy Hay Fever Pinkeye

Drug Information available for: Fluticasone propionate Fluticasone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment
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

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 ]

Secondary Outcome Measures:

Histamine, LTC4, TNF-alpha, IL-5 and IL-13 [ Time Frame: Samples taken at initial visit & 2 week follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	April 2009
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo nasal spray: Placebo Comparator	Drug: Placebo nasal spray 2 sprays each nostril every morning for 2 weeks
Fluticasone furoate nasal spray: Active Comparator	Drug: Fluticasone furoate nasal spray 2 sprays each nostril every morning for 2 weeks

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:	Rush University Medical Center ( James N. Moy, MD )
Study ID Numbers:	RUMCgsk 113002
Study First Received:	April 30, 2009
Last Updated:	April 30, 2009
ClinicalTrials.gov Identifier:	NCT00891436 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Anti-Inflammatory Agents
Lacerations
Conjunctivitis, Allergic
Eye Diseases
Anti-Asthmatic Agents
Conjunctivitis
Anti-Allergic Agents

Conjunctival Diseases
Hypersensitivity
Rhinitis, Allergic, Seasonal
Hypersensitivity, Immediate
Fluticasone
Peripheral Nervous System Agents
Bronchodilator Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Conjunctivitis, Allergic
Immune System Diseases
Eye Diseases
Physiological Effects of Drugs
Anti-Asthmatic Agents
Anti-Allergic Agents
Conjunctivitis
Conjunctival Diseases

Pharmacologic Actions
Hypersensitivity
Autonomic Agents
Therapeutic Uses
Hypersensitivity, Immediate
Fluticasone
Peripheral Nervous System Agents
Dermatologic Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on May 07, 2009