| July 17, 2007 |
| August 20, 2009 |
| 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 ] |
| 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- Mean Change From Baseline in Morning Peak Nasal Inspiratory Flow (PNIF) [ Time Frame: Baseline and Weeks 1-2 ] [ Designated as safety issue: No ]
- Mean Change From Baseline in Evening Peak Nasal Inspiratory Flow (PNIF) [ Time Frame: Baseline and Weeks 1-2 ] [ Designated as safety issue: No ]
- 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 ]
|
| 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 |
| |
| 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 |
| |
| Phase IV |
| Interventional |
| Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study |
- Allergic Rhinitis
- Hayfever
|
| Drug: fluticasone furoate, fexofenadine |
| |
| |
| |
| 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 |
| |
| NCT00502775 |
| Study Director, GSK |
| FFU109047 |
| GlaxoSmithKline |
|
| Study Director: |
GSK Clinical Trials, MD |
GlaxoSmithKline |
|
|
| GlaxoSmithKline |
| August 2009 |