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: June 15, 2015
Last verified: June 2015

July 17, 2007
June 15, 2015
August 2007
November 2007   (final data collection date for primary outcome measure)
Mean Change From Baseline in the Nighttime Symptom Score (NSS) [ Time Frame: Baseline and Weeks 1-2 ] [ Designated as safety issue: No ]
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.
The mean change from baseline over the two-week treatment period in the nighttime symptoms score.
Complete list of historical versions of study NCT00502775 on ClinicalTrials.gov Archive Site
  • Mean Change From Baseline in Nighttime Reflective Total Nasal Symptom Score (N-rTNSS) [ Time Frame: Baseline and Weeks 1-2 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
The mean change from baseline over the two-week treatment period in N-rTNSS, D-rTNSS, 24-hour rTNSS, N-rTOSS, D-rTOSS, 24-hour rTOSS, pre-dose iTNSS, pre-dose iTOSS
Not Provided
Not Provided
 
Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine
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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Rhinitis, Allergic, Seasonal
Drug: fluticasone furoate, fexofenadine
Other Names:
  • fluticasone furoate
  • fexofenadine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
680
November 2007
November 2007   (final data collection date for primary outcome measure)

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
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
Argentina
 
NCT00502775
FFU109047
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP