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Comparator Study Evaluating Patient Preference Of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS)
This study has been completed.
Study NCT00539006   Information provided by GlaxoSmithKline
First Received: October 2, 2007   Last Updated: September 29, 2009   History of Changes
Study Type: Interventional
Study Design: Randomized, Double-Blind, Crossover Assignment
Condition: Seasonal Allergic Rhinitis
Interventions: Drug: fluticasone propionate
Drug: fluticasone furoate
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Fluticasone Furoate NS/Fluticasone Propionate NS Participants who received Fluticasone Furoate Nasal Spray (FFNS) 110 mcg every day (QD) followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
Placebo - FF/FP Participants who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
Fluticasone Propionate NS/Fluticasone Furoate NS Participants who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
Placebo - FP/FF Participants who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.

Participant Flow for 5 periods

Period:   Pre-treatment
  Fluticasone Furoate NS/Fluticasone Propionate NS Placebo - FF/FP Fluticasone Propionate NS/Fluticasone Furoate NS Placebo - FP/FF
STARTED   96     95     95     91  
COMPLETED   96     94     95     91  
NOT COMPLETED   0     1     0     0  
      Unknown               0                 1                 0                 0  

Period:   Treatment Period 1
  Fluticasone Furoate NS/Fluticasone Propionate NS Placebo - FF/FP Fluticasone Propionate NS/Fluticasone Furoate NS Placebo - FP/FF
STARTED   96     94     95     91  
COMPLETED   96     94     93     90  
NOT COMPLETED   0     0     2     1  
      Lost to Follow-up               0                 0                 1                 0  
      Protocol Violation               0                 0                 1                 0  
      Lack of Efficacy               0                 0                 0                 1  

Period:   Washout
  Fluticasone Furoate NS/Fluticasone Propionate NS Placebo - FF/FP Fluticasone Propionate NS/Fluticasone Furoate NS Placebo - FP/FF
STARTED   96     94     93     90  
COMPLETED   76     84     77     81  
NOT COMPLETED   20     10     16     9  
      Adverse Event               2                 1                 0                 0  
      Protocol Violation               1                 1                 0                 0  
      Withdrawal by Subject               0                 2                 0                 0  
      Failed to meet continuation criteria               16                 5                 14                 6  
      Unknown               1                 1                 2                 3  

Period:   Treatment Period 2
  Fluticasone Furoate NS/Fluticasone Propionate NS Placebo - FF/FP Fluticasone Propionate NS/Fluticasone Furoate NS Placebo - FP/FF
STARTED   76     84     77     81  
COMPLETED   75     83     77     81  
NOT COMPLETED   1     1     0     0  
      Protocol Violation               1                 0                 0                 0  
      Unknown               0                 1                 0                 0  

Period:   Post-Study
  Fluticasone Furoate NS/Fluticasone Propionate NS Placebo - FF/FP Fluticasone Propionate NS/Fluticasone Furoate NS Placebo - FP/FF
STARTED   75     83     77     81  
COMPLETED   75     83     77     81  
NOT COMPLETED   0     0     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Fluticasone Furoate NS/Fluticasone Propionate NS Participants who received Fluticasone Furoate Nasal Spray (FFNS) 110 mcg every day (QD) followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
Placebo - FF/FP Participants who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
Fluticasone Propionate NS/Fluticasone Furoate NS Participants who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
Placebo - FP/FF Participants who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.

Baseline Measures
  Fluticasone Furoate NS/Fluticasone Propionate NS Placebo - FF/FP Fluticasone Propionate NS/Fluticasone Furoate NS Placebo - FP/FF Total
Number of Participants  
[units: participants]
96 95 95 91 377
Age  
[units: years]
Mean ± Standard Deviation
37.3 ± 13.89 42 ± 12.48 40.5 ± 12.29 39.7 ± 14.32 39.9 ± 13.33
Gender  
[units: participants]
         
Female 62 73 67 60 262
Male 34 22 28 31 115
Race/Ethnicity, Customized  
[units: participants]
         
American/African Heritage 8 8 10 8 34
American Indian or Alaska Native 0 0 0 0 0
Asian 0 3 1 1 5
Native Hawaiian or other Pacific Islander 0 0 1 0 1
White 88 84 82 80 334
African American/African-American Indian/Alaskan 0 0 0 1 1
African American/African Heritage & White 0 0 1 1 2



  Outcome Measures
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1.  Primary:   Comparison of Mean Change From Baseline in Daily Reflective Total Nasal Symptom Score (rTNSS) Over Treatment Periods of Active Drug Nasal Sprays Versus Placebos   [ Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21) ]

2.  Primary:   Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Scent/Odor   [ End of Crossover Period (Day 22) ]

3.  Secondary:   Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Leaking Out of Nose/Down Throat   [ End of Crossover Period (Day 22) ]

4.  Secondary:   Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Ease of Use   [ End of Crossover Period (Day 22) ]

5.  Secondary:   Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Gentleness of Mist   [ End of Crossover Period (Day 22) ]

6.  Secondary:   Comparision of Mean Change From Baseline Over Treatment Periods in Daytime Reflective Total Nasal Symptom Scores (D r-TNSS) for Active Drug Nasal Sprays Versus Placebos   [ Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21) ]

7.  Secondary:   Comparision of Mean Change From Baseline Over Treatment Periods in Nighttime Reflective Total Nasal Symptom Scores (N-rTNSS) for Active Drug Nasal Sprays Versus Placebos   [ Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21) ]


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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