Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine

October 27, 2016 updated by: GlaxoSmithKline

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

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

Study Overview

Status

Completed

Conditions

Rhinitis, Allergic, Seasonal

Intervention / Treatment

Drug: fluticasone furoate, fexofenadine

Study Type

Interventional

Enrollment (Actual)

680

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Arkansas
  - Little Rock, Arkansas, United States, 72205
    - GSK Investigational Site
- Georgia
  - Albany, Georgia, United States, 31707
    - GSK Investigational Site
  - Columbus, Georgia, United States, 31904
    - GSK Investigational Site
  - Lawrenceville, Georgia, United States, 30045
    - GSK Investigational Site
- Illinois
  - Chicago, Illinois, United States, 60637
    - GSK Investigational Site
  - Normal, Illinois, United States, 61761
    - GSK Investigational Site
- Indiana
  - Evansville, Indiana, United States, 47713
    - GSK Investigational Site
  - Indianapolis, Indiana, United States, 46208
    - GSK Investigational Site
  - Lafayette, Indiana, United States, 47904
    - GSK Investigational Site
  - South Bend, Indiana, United States, 46617
    - GSK Investigational Site
- Iowa
  - Iowa City, Iowa, United States, 52242
    - GSK Investigational Site
- Kentucky
  - Louisville, Kentucky, United States, 40215
    - GSK Investigational Site
  - Owensboro, Kentucky, United States, 42301
    - GSK Investigational Site
- Louisiana
  - Metairie, Louisiana, United States, 70006
    - GSK Investigational Site
  - Sunset, Louisiana, United States, 70584
    - GSK Investigational Site
- Michigan
  - Novi, Michigan, United States, 48375
    - GSK Investigational Site
  - Ypsilanti, Michigan, United States, 48197
    - GSK Investigational Site
- Minnesota
  - Minneapolis, Minnesota, United States, 55402
    - GSK Investigational Site
  - Plymouth, Minnesota, United States, 55441
    - GSK Investigational Site
- Mississippi
  - Jackson, Mississippi, United States, 39202
    - GSK Investigational Site
- Missouri
  - Columbia, Missouri, United States, 65203
    - GSK Investigational Site
  - Rolla, Missouri, United States, 65401
    - GSK Investigational Site
  - St. Louis, Missouri, United States, 63141
    - GSK Investigational Site
  - St. Louis, Missouri, United States, 63110
    - GSK Investigational Site
  - Warrensburg, Missouri, United States, 64093
    - GSK Investigational Site
- Nebraska
  - Lincoln, Nebraska, United States, 68505
    - GSK Investigational Site
  - Omaha, Nebraska, United States, 68124
    - GSK Investigational Site
  - Omaha, Nebraska, United States, 68130
    - GSK Investigational Site
  - Papillion, Nebraska, United States, 68046
    - GSK Investigational Site
- Ohio
  - Canton, Ohio, United States, 44718
    - GSK Investigational Site
  - Cincinnati, Ohio, United States, 45231
    - GSK Investigational Site
  - Sylvania, Ohio, United States, 43560
    - GSK Investigational Site
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73120
    - GSK Investigational Site
- Pennsylvania
  - Pittsburgh, Pennsylvania, United States, 15241
    - GSK Investigational Site
- South Carolina
  - Charleston, South Carolina, United States, 29407
    - GSK Investigational Site
  - Orangeburg, South Carolina, United States, 29118
    - GSK Investigational Site
  - Spartanburg, South Carolina, United States, 29303
    - GSK Investigational Site
- Tennessee
  - Knoxville, Tennessee, United States, 37909
    - GSK Investigational Site
- Texas
  - Waco, Texas, United States, 76712
    - GSK Investigational Site
- Wisconsin
  - Greenfield, Wisconsin, United States, 53228
    - GSK Investigational Site
  - Milwaukee, Wisconsin, United States, 53209
    - GSK Investigational Site
  - West Allis, Wisconsin, United States, 53227
    - GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline in the Nighttime Symptom Score (NSS) Time Frame: Baseline and Weeks 1-2	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline in Nighttime Reflective Total Nasal Symptom Score (N-rTNSS) Time Frame: Baseline and Weeks 1-2	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
Mean Change From Baseline in Daytime Reflective Total Nasal Symptom Score (D-rTNSS) Time Frame: Baseline and Weeks 1-2	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
Mean Change From Baseline in 24 Hour Reflective Total Nasal Symptom Score (24 Hour rTNSS) Time Frame: Baseline and Weeks 1-2	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
Mean Change From Baseline in Nighttime Reflective Total Ocular Symptom Score (N-rTOSS) Time Frame: Baseline and Weeks 1-2	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
Mean Change From Baseline in Daytime Reflective Total Ocular Symptom Score (D-rTOSS) Time Frame: Baseline and Weeks 1-2	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
Mean Change From Baseline in 24 Hour Reflective Total Ocular Symptoms Score (rTOSS) Time Frame: Baseline and Weeks 1-2	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
Mean Change From Baseline in Pre-Dose Instantaneous Total Nasal Symptom Score (iTNSS) Time Frame: Baseline and Weeks 1-2	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
Mean Change From Baseline in Pre-Dose Instantaneous Total Ocular Symptom Score (iTOSS) Time Frame: Baseline and Weeks 1-2	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
Mean Change From Baseline in Morning Peak Nasal Inspiratory Flow (PNIF) Time Frame: Baseline and Weeks 1-2	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
Mean Change From Baseline in Evening Peak Nasal Inspiratory Flow (PNIF) Time Frame: Baseline and Weeks 1-2	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
Mean Change From Baseline at Day 15 for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) Time Frame: Baseline, Day 15 or if Early Withdrawal Day	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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

July 17, 2007

First Submitted That Met QC Criteria

July 17, 2007

First Posted (Estimate)

July 18, 2007

Study Record Updates

Last Update Posted (Estimate)

December 9, 2016

Last Update Submitted That Met QC Criteria

October 27, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

FFU109047

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

Clinical Study Report
Information identifier: FFU109047

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification
Information identifier: FFU109047

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan
Information identifier: FFU109047

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form
Information identifier: FFU109047

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol
Information identifier: FFU109047

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set
Information identifier: FFU109047

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form
Information identifier: FFU109047

Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.