Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine

Completed · Phase 4

Conditions studied: Rhinitis, Allergic, Seasonal

In brief

The primary objective of the study is to compare nighttime symptom relief of fluticasone furoate nasal spray versus oral fexofenadine

Key facts

Study ID

NCT00502775

Run by

GlaxoSmithKline

People needed

680

Starts

2007-08-01

Expected to finish

2007-11-01

Last updated by the study team

2016-12-09

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Informed consent
• Otherwise healthy outpatient with mountain cedar allergy
• Male or eligible female Females of childbearing potential must commit to the consistent and correct use of an acceptable method of birth control
• Age 12 years or older at Visit 2
• Diagnosis of seasonal allergic rhinitis (SAR) to mountain cedar
• Adequate exposure to mountain cedar pollen
• Ability to comply with study procedures
• Literate

You may not qualify if…

• Significant concomitant medical conditions
• Use of intranasal corticosteroids within four weeks prior to Visit 1; use of inhaled, oral, intramuscular, intravenous, ocular, and/or dermatological corticosteroid (with the exception of hydrocortisone cream/ointment, 1% or less) within eight weeks prior to Visit 1.
• Use of other allergy medications within specific timeframes relative to Visit 1
• Use of other medications that may affect allergic rhinitis or its symptoms
• Use of immunosuppressive medications eight weeks prior to screening and during the study
• Immunotherapy patients who are not stable on current dose
• Use of any medications that significantly alters the pharmacokinetics of fluticasone furoate or fexofenadine
• Allergy/Intolerance to corticosteroids, antihistamines, or any excipients in the two products
• Use of contact lenses
• Recent clinical trial/experimental medication experience within 30 days of Visit 1
• Subject previously failed the 21-day screen period or failed to complete the treatment period
• Positive or inconclusive pregnancy test or female who is breastfeeding
• Employee or relative affiliation with investigational site
• Current tobacco use
• Active chickenpox or measles or exposure in the last 3 weeks

Where it is running

• GSK Investigational Site — Little Rock, Arkansas, United States
• GSK Investigational Site — Albany, Georgia, United States
• GSK Investigational Site — Columbus, Georgia, United States
• GSK Investigational Site — Lawrenceville, Georgia, United States
• GSK Investigational Site — Chicago, Illinois, United States
• GSK Investigational Site — Normal, Illinois, United States
• GSK Investigational Site — Evansville, Indiana, United States
• GSK Investigational Site — Indianapolis, Indiana, United States
• GSK Investigational Site — Lafayette, Indiana, United States
• GSK Investigational Site — South Bend, Indiana, United States
• GSK Investigational Site — Iowa City, Iowa, United States
• GSK Investigational Site — Louisville, Kentucky, United States
• GSK Investigational Site — Owensboro, Kentucky, United States
• GSK Investigational Site — Metairie, Louisiana, United States
• GSK Investigational Site — Sunset, Louisiana, United States
• GSK Investigational Site — Novi, Michigan, United States
• GSK Investigational Site — Ypsilanti, Michigan, United States
• GSK Investigational Site — Minneapolis, Minnesota, United States
• GSK Investigational Site — Plymouth, Minnesota, United States
• GSK Investigational Site — Jackson, Mississippi, United States
• GSK Investigational Site — Columbia, Missouri, United States
• GSK Investigational Site — Rolla, Missouri, United States
• GSK Investigational Site — St Louis, Missouri, United States
• GSK Investigational Site — St Louis, Missouri, United States
• GSK Investigational Site — Warrensburg, Missouri, United States

Full record on ClinicalTrials.gov

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