Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Rhinitis, Allergic, Seasonal

Treatments: Drug: Fluticasone furoate and fexofenadine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00435461

FFU109045

Details and patient eligibility

About

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

Enrollment: 1,000 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed consent.
• Outpatient.
• Females of child-bearing potential must use appropriate contraception.
• Diagnosis of seasonal allergic rhinitis to mountain cedar.
• Adequate exposure to allergen.
• Able to comply with study procedures.
• Literate.

Exclusion criteria

• Significant concomitant medical condition.
• Use of corticosteroids, allergy medications, or other medication that affect allergic rhinitis
• Positive pregnancy test.
• Allergy to any component of the investigational product.
• Tobacco use
• Contact lens use
• Has chickenpox or measles or recent exposure
• Other clinical trial drug exposure in last 30 days
• Affiliation with clinic site