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Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00502775
First received: July 17, 2007
Last updated: October 27, 2016
Last verified: October 2016
  Purpose
The primary objective of the study is to compare nighttime symptom relief of fluticasone furoate nasal spray versus oral fexofenadine

Condition Intervention Phase
Rhinitis, Allergic, Seasonal Drug: fluticasone furoate, fexofenadine Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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:
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.


Enrollment: 680
Study Start Date: August 2007
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: fluticasone furoate, fexofenadine
    Other Names:
    • fluticasone furoate
    • fexofenadine
  Eligibility

Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00502775

  Show 42 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: FFU109047
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: FFU109047
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: FFU109047
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: FFU109047
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: FFU109047
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: FFU109047
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: FFU109047
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00502775     History of Changes
Other Study ID Numbers: FFU109047
Study First Received: July 17, 2007
Results First Received: November 17, 2008
Last Updated: October 27, 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
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
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
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 21, 2017