Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine

Rhinitis, Allergic, Seasonal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00502775
• Other study ID #: FFU109047
• Status: Completed
• Phase: Phase 4
• First received: July 17, 2007
• Last updated: June 15, 2015
• Start date: August 2007
• Est. completion date: November 2007

Study information

• Verified date: June 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 680
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic, Seasonal

Intervention

Drug:
• fluticasone furoate, fexofenadine

Locations

Country	Name	City	State
United States	GSK Investigational Site	Albany	Georgia
United States	GSK Investigational Site	Canton	Ohio
United States	GSK Investigational Site	Charleston	South Carolina
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Columbia	Missouri
United States	GSK Investigational Site	Columbus	Georgia
United States	GSK Investigational Site	Evansville	Indiana
United States	GSK Investigational Site	Greenfield	Wisconsin
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	Iowa City	Iowa
United States	GSK Investigational Site	Jackson	Mississippi
United States	GSK Investigational Site	Knoxville	Tennessee
United States	GSK Investigational Site	Lafayette	Indiana
United States	GSK Investigational Site	Lawrenceville	Georgia
United States	GSK Investigational Site	Lincoln	Nebraska
United States	GSK Investigational Site	Little Rock	Arkansas
United States	GSK Investigational Site	Louisville	Kentucky
United States	GSK Investigational Site	Metairie	Louisiana
United States	GSK Investigational Site	Milwaukee	Wisconsin
United States	GSK Investigational Site	Minneapolis	Minnesota
United States	GSK Investigational Site	Normal	Illinois
United States	GSK Investigational Site	Novi	Michigan
United States	GSK Investigational Site	Oklahoma City	Oklahoma
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Orangeburg	South Carolina
United States	GSK Investigational Site	Owensboro	Kentucky
United States	GSK Investigational Site	Papillion	Nebraska
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Plymouth	Minnesota
United States	GSK Investigational Site	Rolla	Missouri
United States	GSK Investigational Site	South Bend	Indiana
United States	GSK Investigational Site	Spartanburg	South Carolina
United States	GSK Investigational Site	St. Louis	Missouri
United States	GSK Investigational Site	St. Louis	Missouri
United States	GSK Investigational Site	Sunset	Louisiana
United States	GSK Investigational Site	Sylvania	Ohio
United States	GSK Investigational Site	Waco	Texas
United States	GSK Investigational Site	Warrensburg	Missouri
United States	GSK Investigational Site	West Allis	Wisconsin
United States	GSK Investigational Site	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline in the Nighttime Symptom Score (NSS)	Questions include: 1. Nasal congestion on awakening (Score: 0=none, 1=mild, 2=moderate, 3=severe); 2. Difficulty going to sleep (Score: 0=not at all, 1=little, 2=moderately, 3=very); 3. Nighttime awakenings (Score: 0=not at all, 1=once, 2=more than once, 3=felt like awake all night). The sum of the ratings for the three items comprises the NSS.	Baseline and Weeks 1-2	No
Secondary	Mean Change From Baseline in Nighttime Reflective Total Nasal Symptom Score (N-rTNSS)	Subjects assessed four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing). The sum of the four nasal symptoms comprised the total nasal symptom score (TNSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.	Baseline and Weeks 1-2	No
Secondary	Mean Change From Baseline in Daytime Reflective Total Nasal Symptom Score (D-rTNSS)	Subjects assessed four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing). The sum of the four nasal symptoms comprised the total nasal symptom score (TNSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.	Baseline and Weeks 1-2	No
Secondary	Mean Change From Baseline in 24 Hour Reflective Total Nasal Symptom Score (24 Hour rTNSS)	Subjects assessed four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing). The sum of the four nasal symptoms comprised the total nasal symptom score (TNSS).Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.	Baseline and Weeks 1-2	No
Secondary	Mean Change From Baseline in Nighttime Reflective Total Ocular Symptom Score (N-rTOSS)	Subjects assessed three ocular symptoms (itching/ burning eyes, tearing/watering eyes, and eye redness). The sum of the 3 ocular symptoms comprised the total ocular symptom score (TOSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.	Baseline and Weeks 1-2	No
Secondary	Mean Change From Baseline in Daytime Reflective Total Ocular Symptom Score (D-rTOSS)	Subjects assessed three ocular symptoms (itching/ burning eyes, tearing/watering eyes, and eye redness). The sum of the 3 ocular symptoms comprised the total ocular symptom score (TOSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.	Baseline and Weeks 1-2	No
Secondary	Mean Change From Baseline in 24 Hour Reflective Total Ocular Symptoms Score (rTOSS)	Subjects assessed three ocular symptoms (itching/ burning eyes, tearing/watering eyes, and eye redness). The sum of the 3 ocular symptoms comprised the total ocular symptom score (TOSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.	Baseline and Weeks 1-2	No
Secondary	Mean Change From Baseline in Pre-Dose Instantaneous Total Nasal Symptom Score (iTNSS)	Subjects assessed four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing). The sum of the four nasal symptoms comprised the total nasal symptom score (TNSS).Instantaneous rating represented symptoms at the time of the assessment. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.	Baseline and Weeks 1-2	No
Secondary	Mean Change From Baseline in Pre-Dose Instantaneous Total Ocular Symptom Score (iTOSS)	Subjects assessed three ocular symptoms (itching/ burning eyes, tearing/watering eyes, and eye redness). The sum of the four ocular symptoms comprised the total nasal symptom score (TOSS).Instantaneous rating represented symptoms at the time of the assessment. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.	Baseline and Weeks 1-2	No
Secondary	Mean Change From Baseline in Morning Peak Nasal Inspiratory Flow (PNIF)	Subjects used a portable hand-held inspiratory flow meter to measure and record PNIF in the morning prior to taking the study medication. Three measurements were taken and the highest measurement was recorded in the electronic diary. A positive change signifies improved nasal air flow.	Baseline and Weeks 1-2	No
Secondary	Mean Change From Baseline in Evening Peak Nasal Inspiratory Flow (PNIF)	Subjects used a portable hand-held inspiratory flow meter to measure and record PNIF in the evening. Three measurements were taken and the highest measurement was recorded in the electronic diary. A positive change signifies improved nasal air flow.	Baseline and Weeks 1-2	No
Secondary	Mean Change From Baseline at Day 15 for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ)	Subjects completed the 16-item Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ)to assess nocturnal rhinitis-related quality of life. The NRQLQ measures the functional problems most troublesome to patients with nocturnal allergy symptoms. Each question scored from 0-6 with higher scores indicating more nocturnal impairment.	Baseline, Day 15 or if Early Withdrawal Day	No