Clinical trial NCT00502775: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rhinitis, Allergic, Seasonal
Keywords: ragweed
once daily
fexofenadine
fluticasone furoate
allergic rhinitis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-07-18
Enrollment: 680
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Mean Change From Baseline in the Nighttime Symptom Score (NSS)
timeFrame: Baseline and Weeks 1-2
Secondary outcomes:
measure: Mean Change From Baseline in Nighttime Reflective Total Nasal Symptom Score (N-rTNSS)
timeFrame: Baseline and Weeks 1-2
measure: Mean Change From Baseline in Daytime Reflective Total Nasal Symptom Score (D-rTNSS)
timeFrame: Baseline and Weeks 1-2
measure: Mean Change From Baseline in 24 Hour Reflective Total Nasal Symptom Score (24 Hour rTNSS)
timeFrame: Baseline and Weeks 1-2
measure: Mean Change From Baseline in Nighttime Reflective Total Ocular Symptom Score (N-rTOSS)
timeFrame: Baseline and Weeks 1-2
measure: Mean Change From Baseline in Daytime Reflective Total Ocular Symptom Score (D-rTOSS)
timeFrame: Baseline and Weeks 1-2
measure: Mean Change From Baseline in 24 Hour Reflective Total Ocular Symptoms Score (rTOSS)
timeFrame: Baseline and Weeks 1-2
measure: Mean Change From Baseline in Pre-Dose Instantaneous Total Nasal Symptom Score (iTNSS)
timeFrame: Baseline and Weeks 1-2
measure: Mean Change From Baseline in Pre-Dose Instantaneous Total Ocular Symptom Score (iTOSS)
timeFrame: Baseline and Weeks 1-2
measure: Mean Change From Baseline in Morning Peak Nasal Inspiratory Flow (PNIF)
timeFrame: Baseline and Weeks 1-2
measure: Mean Change From Baseline in Evening Peak Nasal Inspiratory Flow (PNIF)
timeFrame: Baseline and Weeks 1-2
measure: Mean Change From Baseline at Day 15 for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ)
timeFrame: Baseline, Day 15 or if Early Withdrawal Day
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Albany
country: United States
facility: GSK Investigational Site
state: Georgia
city: Columbus
country: United States
facility: GSK Investigational Site
state: Georgia
city: Lawrenceville
country: United States
facility: GSK Investigational Site
state: Georgia
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: Normal
country: United States
facility: GSK Investigational Site
state: Illinois
city: Evansville
country: United States
facility: GSK Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: GSK Investigational Site
state: Indiana
city: Lafayette
country: United States
facility: GSK Investigational Site
state: Indiana
city: South Bend
country: United States
facility: GSK Investigational Site
state: Indiana
city: Iowa City
country: United States
facility: GSK Investigational Site
state: Iowa
city: Louisville
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Owensboro
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Metairie
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Sunset
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Novi
country: United States
facility: GSK Investigational Site
state: Michigan
city: Ypsilanti
country: United States
facility: GSK Investigational Site
state: Michigan
city: Minneapolis
country: United States
facility: GSK Investigational Site
state: Minnesota
city: Plymouth
country: United States
facility: GSK Investigational Site
state: Minnesota
city: Jackson
country: United States
facility: GSK Investigational Site
state: Mississippi
city: Columbia
country: United States
facility: GSK Investigational Site
state: Missouri
city: Rolla
country: United States
facility: GSK Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: GSK Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: GSK Investigational Site
state: Missouri
city: Warrensburg
country: United States
facility: GSK Investigational Site
state: Missouri
city: Lincoln
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Omaha
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Omaha
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Papillion
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Canton
country: United States
facility: GSK Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: Sylvania
country: United States
facility: GSK Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Orangeburg
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Spartanburg
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Knoxville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Waco
country: United States
facility: GSK Investigational Site
state: Texas
city: Greenfield
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Milwaukee
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: West Allis
country: United States
facility: GSK Investigational Site
state: Wisconsin
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: