The primary objective of the study is to compare nighttime symptom relief of fluticasone
furoate nasal spray versus oral fexofenadine
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
Inclusion criteria:
- 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
Exclusion criteria:
- 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
GSK Investigational Site, Little Rock, Arkansas 72205, United States
GSK Investigational Site, Albany, Georgia 31707, United States
GSK Investigational Site, Columbus, Georgia 31904, United States
GSK Investigational Site, Lawrenceville, Georgia 30045, United States
GSK Investigational Site, Chicago, Illinois 60637, United States
GSK Investigational Site, Normal, Illinois 61761, United States
GSK Investigational Site, Evansville, Indiana 47713, United States
GSK Investigational Site, Indianapolis, Indiana 46208, United States
GSK Investigational Site, Lafayette, Indiana 47904, United States
GSK Investigational Site, South Bend, Indiana 46617, United States
GSK Investigational Site, Iowa City, Iowa 52242, United States
GSK Investigational Site, Louisville, Kentucky 40215, United States
GSK Investigational Site, Owensboro, Kentucky 42301, United States
GSK Investigational Site, Metairie, Louisiana 70006, United States
GSK Investigational Site, Sunset, Louisiana 70584, United States
GSK Investigational Site, Novi, Michigan 48375, United States
GSK Investigational Site, Ypsilanti, Michigan 48197, United States
GSK Investigational Site, Minneapolis, Minnesota 55402, United States
GSK Investigational Site, Plymouth, Minnesota 55441, United States
GSK Investigational Site, Jackson, Mississippi 39202, United States
GSK Investigational Site, Columbia, Missouri 65203, United States
GSK Investigational Site, Rolla, Missouri 65401, United States
GSK Investigational Site, St. Louis, Missouri 63110, United States
GSK Investigational Site, St. Louis, Missouri 63141, United States
GSK Investigational Site, Warrensburg, Missouri 64093, United States
GSK Investigational Site, Lincoln, Nebraska 68505, United States
GSK Investigational Site, Omaha, Nebraska 68130, United States
GSK Investigational Site, Omaha, Nebraska 68124, United States
GSK Investigational Site, Papillion, Nebraska 68046, United States
GSK Investigational Site, Canton, Ohio 44718, United States
GSK Investigational Site, Cincinnati, Ohio 45231, United States
GSK Investigational Site, Sylvania, Ohio 43560, United States
GSK Investigational Site, Oklahoma City, Oklahoma 73120, United States
GSK Investigational Site, Pittsburgh, Pennsylvania 15241, United States
GSK Investigational Site, Charleston, South Carolina 29407, United States
GSK Investigational Site, Orangeburg, South Carolina 29118, United States
GSK Investigational Site, Spartanburg, South Carolina 29303, United States
GSK Investigational Site, Knoxville, Tennessee 37909, United States
GSK Investigational Site, Waco, Texas 76712, United States
GSK Investigational Site, Greenfield, Wisconsin 53228, United States
GSK Investigational Site, Milwaukee, Wisconsin 53209, United States
GSK Investigational Site, West Allis, Wisconsin 53227, United States