Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine

Condition(s) targeted: Allergic Rhinitis; Hay Fever

Intervention: fluticasone furoate, fexofenadine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Chair, Affiliation: GlaxoSmithKline

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

Official title: A Comparison of Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine in the Treatment of Seasonal Allergic Rhinitis

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: The mean change from baseline over the two-week treatment period in the nighttime symptoms score.

Secondary outcome:

The mean change from baseline over the two-week treatment period in N-rTNSS, D-rTNSS, 24-hour rTNSS, N-rTOSS, D-rTOSS, 24-hour rTOSS, pre-dose iTNSS, pre-dose iTOSS

Mean change from baseline over the two-week treatment period in the following:

• Nighttime, Daytime, and 24-hour reflective total nasal symptom scores (N-rTNSS, D-rTNSS, and 24-hour rTNSS, respectively)

• Nighttime, Daytime, and 24-hour reflective total ocular symptom scores (N-rTOSS, D-rTOSS, and 24-hour rTOSS, respectively)

• Pre-dose instantaneous total nasal and ocular symptom scores, (iTNSS and iTOSS, respectively)

• Peak inspiratory nasal flow (PNIF)

Mean change from baseline for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) results

Frequency and type of clinical adverse events (AEs)

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

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

GSK Clinical Trials Call Center, Little Rock, Arkansas 72205, United States

GSK Clinical Trials Call Center, Lawrenceville, Georgia 30045, United States

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Starting date: August 2007
Ending date: November 2007
Last updated: February 27, 2008