Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 4

Conditions

Rhinitis, Allergic, Seasonal

Treatments

Drug: fluticasone furoate, fexofenadine

Study type

Interventional

Funder types

Industry

Identifiers

FFU109047

Details and patient eligibility

About

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

Enrollment

680 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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