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

NCT00891436 | Completed Phase 4 Results

• 1 other identifier: RUMCgsk 113002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Conjunctivitis to Tree Pollen or Grass Pollen

Outcome Measures

Primary Outcomes (1)

• Eosinophilic Cationic Protein (ECP) Levels

  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.

  Samples taken at initial visit & 2 week follow-up

Secondary Outcomes (1)

• Histamine Content in the Tears Was Measured.

  Samples taken at initial visit & 2 week follow-up

Study Arms (2)

Placebo nasal spray

PLACEBO COMPARATOR

Drug: Placebo nasal spray

Fluticasone furoate nasal spray

ACTIVE COMPARATOR

Drug: Fluticasone furoate nasal spray

Interventions

Fluticasone furoate nasal spray DRUG

2 sprays each nostril every morning for 2 weeks

Also known as: Veramyst

Fluticasone furoate nasal spray

Placebo nasal spray DRUG

2 sprays each nostril every morning for 2 weeks

Placebo nasal spray

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Interventions

Fluticasone

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: James N. Moy, M.D.
• Organization: Rush University Medical College

jmoy@rush.edu

312-942-6176

Study Officials

• J. Moy, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 30, 2009
• First Posted: May 1, 2009
• Study Start: April 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: August 1, 2009
• Last Updated: December 3, 2012
• Results First Posted: October 18, 2012

Record last verified: 2012-11

Locations

US (1)