Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine

• ClinicalTrials.gov Identifier: NCT00502775
• Recruitment Status: Completed
• First Posted: July 18, 2007
• Results First Posted: March 20, 2009
• Last Update Posted: December 9, 2016
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Rhinitis, Allergic, Seasonal	Drug: fluticasone furoate, fexofenadine	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 680 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: A Comparison of Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine in the Treatment of Seasonal Allergic Rhinitis
• Study Start Date: August 2007
• Actual Primary Completion Date: November 2007
• Actual Study Completion Date: November 2007

Arms and Interventions

Intervention Details:

• Drug: fluticasone furoate, fexofenadine
  Other Names:

  • fluticasone furoate
  • fexofenadine

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
9. 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.
10. 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.
11. 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.

Eligibility Criteria

• Ages Eligible for Study: 12 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Arkansas

GSK Investigational Site

Little Rock, Arkansas, United States, 72205

United States, Georgia

GSK Investigational Site

Albany, Georgia, United States, 31707

GSK Investigational Site

Columbus, Georgia, United States, 31904

GSK Investigational Site

Lawrenceville, Georgia, United States, 30045

United States, Illinois

GSK Investigational Site

Chicago, Illinois, United States, 60637

GSK Investigational Site

Normal, Illinois, United States, 61761

United States, Indiana

GSK Investigational Site

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

United States, Iowa

GSK Investigational Site

Iowa City, Iowa, United States, 52242

United States, Kentucky

GSK Investigational Site

Louisville, Kentucky, United States, 40215

GSK Investigational Site

Owensboro, Kentucky, United States, 42301

United States, Louisiana

GSK Investigational Site

Metairie, Louisiana, United States, 70006

GSK Investigational Site

Sunset, Louisiana, United States, 70584

United States, Michigan

GSK Investigational Site

Novi, Michigan, United States, 48375

GSK Investigational Site

Ypsilanti, Michigan, United States, 48197

United States, Minnesota

GSK Investigational Site

Minneapolis, Minnesota, United States, 55402

GSK Investigational Site

Plymouth, Minnesota, United States, 55441

United States, Mississippi

GSK Investigational Site

Jackson, Mississippi, United States, 39202

United States, Missouri

GSK Investigational Site

Columbia, Missouri, United States, 65203

GSK Investigational Site

Rolla, Missouri, United States, 65401

GSK Investigational Site

St. Louis, Missouri, United States, 63110

GSK Investigational Site

St. Louis, Missouri, United States, 63141

GSK Investigational Site

Warrensburg, Missouri, United States, 64093

United States, Nebraska

GSK Investigational Site

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

United States, Ohio

GSK Investigational Site

Canton, Ohio, United States, 44718

GSK Investigational Site

Cincinnati, Ohio, United States, 45231

GSK Investigational Site

Sylvania, Ohio, United States, 43560

United States, Oklahoma

GSK Investigational Site

Oklahoma City, Oklahoma, United States, 73120

United States, Pennsylvania

GSK Investigational Site

Pittsburgh, Pennsylvania, United States, 15241

United States, South Carolina

GSK Investigational Site

Charleston, South Carolina, United States, 29407

GSK Investigational Site

Orangeburg, South Carolina, United States, 29118

GSK Investigational Site

Spartanburg, South Carolina, United States, 29303

United States, Tennessee

GSK Investigational Site

Knoxville, Tennessee, United States, 37909

United States, Texas

GSK Investigational Site

Waco, Texas, United States, 76712

United States, Wisconsin

GSK Investigational Site

Greenfield, Wisconsin, United States, 53228

GSK Investigational Site

Milwaukee, Wisconsin, United States, 53209

GSK Investigational Site

West Allis, Wisconsin, United States, 53227

Sponsors and Collaborators

GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

More Information

Additional Information:

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 Data/Documents: Clinical Study Report 

Identifier: FFU109047
For additional information about this study please refer to the GSK Clinical Study Register

Dataset Specification 

Identifier: FFU109047
For additional information about this study please refer to the GSK Clinical Study Register

Statistical Analysis Plan 

Identifier: FFU109047
For additional information about this study please refer to the GSK Clinical Study Register

Annotated Case Report Form 

Identifier: FFU109047
For additional information about this study please refer to the GSK Clinical Study Register

Study Protocol 

Identifier: FFU109047
For additional information about this study please refer to the GSK Clinical Study Register

Individual Participant Data Set 

Identifier: FFU109047
For additional information about this study please refer to the GSK Clinical Study Register

Informed Consent Form 

Identifier: FFU109047
For additional information about this study please refer to the GSK Clinical Study Register

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00502775
• Other Study ID Numbers: FFU109047
• First Posted: July 18, 2007
• Results First Posted: March 20, 2009
• Last Update Posted: December 9, 2016
• Last Verified: October 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.

Keywords provided by GlaxoSmithKline:

ragweed; once daily; fexofenadine; fluticasone furoate; allergic rhinitis

Additional relevant MeSH terms:

Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Fluticasone; Xhance; Fexofenadine; Terfenadine; Anti-Inflammatory Agents; Bronchodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Asthmatic Agents; Respiratory System Agents; Dermatologic Agents; Anti-Allergic Agents; Histamine H1 Antagonists, Non-Sedating; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Neurotransmitter Agents