Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Fexofenadine; Fluticasone; Terfenadine; Xhance

Criteria

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