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

Tracking Information

First Received Date ^ICMJE

April 30, 2009

Last Updated Date

April 30, 2009

Start Date ^ICMJE

April 2009

Estimated Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Eosinophilic cationic protein (ECP) levels [ Time Frame: Samples taken at initial visit & 2 week follow-up ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment

Condition ^ICMJE

Allergic Conjunctivitis to Tree Pollen or Grass Pollen

Intervention ^ICMJE

Drug: Fluticasone furoate nasal spray
2 sprays each nostril every morning for 2 weeks

Other Name: Veramyst
Drug: Placebo nasal spray
2 sprays each nostril every morning for 2 weeks

Study Arms / Comparison Groups

Placebo nasal spray: Placebo Comparator
Intervention: Drug: Placebo nasal spray
Fluticasone furoate nasal spray: Active Comparator
Intervention: Drug: Fluticasone furoate nasal spray

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2009

Estimated Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00891436

Responsible Party

James N. Moy, MD, Rush University Medical Center

Study ID Numbers ^ICMJE

RUMCgsk 113002

Study Sponsor ^ICMJE

Rush University Medical Center

Collaborators ^ICMJE

GlaxoSmithKline

Investigators ^ICMJE

Principal Investigator:

J. Moy, MD

Rush University Medical Center

Information Provided By

Rush University Medical Center

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP