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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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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
  Show All Outcome Measures

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) ]
  Hide Outcome Measure 1

Measure Type Primary
Measure Title Comparison of Mean Change From Baseline in Daily Reflective Total Nasal Symptom Score (rTNSS) Over Treatment Periods of Active Drug Nasal Sprays Versus Placebos
Measure Description Reflective Total Nasal Symptom scores (rTNSS) symptoms of rhinorrhea, nasal congestion, nasal itching, sneezing using scale of: 0=none, 1=mild, 2=moderate, 3=severe; maximum score=12. The mean of AM and PM scores were used.
Time Frame Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-Treat (ITT) population consisted of all participants who were randomized to study treatment, and was to form the basis of all summaries of background, demographic, safety, and efficacy data.

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.

Measured Values
  Fluticasone Furoate NS/Fluticasone Propionate NS Placebo - FF/FP Fluticasone Propionate NS/Fluticasone Furoate NS Placebo - FP/FF
Number of Participants Analyzed
[units: participants] 		96 93 95 89
Comparison of Mean Change From Baseline in Daily Reflective Total Nasal Symptom Score (rTNSS) Over Treatment Periods of Active Drug Nasal Sprays Versus Placebos
[units: Scores on a scale]
Mean ± Standard Error 		       
Change from Baseline Treatment Period One -2.7 ± 0.29 -1.5 ± 0.20 -2.4 ± 0.24 -1.6 ± 0.22
Change from Baseline Treatment Period Two -2.5 ± 0.29 -1.9 ± 0.24 -2.7 ± 0.27 -1.7 ± 0.21


Statistical Analysis 1 for Comparison of Mean Change From Baseline in Daily Reflective Total Nasal Symptom Score (rTNSS) Over Treatment Periods of Active Drug Nasal Sprays Versus Placebos
Groups [1] Fluticasone Furoate NS/Fluticasone Propionate NS vs. Placebo - FF/FP
Method [2] ANCOVA
P Value [3] <0.001
Mean Difference (Net) [4] -1.1
Standard Error of the mean ± 0.22
95% Confidence Interval ( -1.5 to -0.6 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  FFNS combined across treatment arms 1 & 2 compared with Placebo FFNS combined across treatment arms 1 & 2.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Mean Difference = Mean Change in FFNS - Mean Change in Placebo

Statistical Analysis 2 for Comparison of Mean Change From Baseline in Daily Reflective Total Nasal Symptom Score (rTNSS) Over Treatment Periods of Active Drug Nasal Sprays Versus Placebos
Groups [1] Fluticasone Propionate NS/Fluticasone Furoate NS vs. Placebo - FP/FF
Method [2] ANCOVA
P Value [3] 0.004
Mean Difference (Net) [4] -0.6
Standard Error of the mean ± 0.22
95% Confidence Interval ( -1.1 to -0.2 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  FPNS combined across treatment arms 1 & 2 compared with Placebo FPNS combined across treatment arms 1 & 2.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Mean Difference = Mean Change in FPNS - Mean Change in Placebo



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) ]
  Show Outcome Measure 2

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) ]
  Show Outcome Measure 3

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) ]
  Show Outcome Measure 4

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) ]
  Show Outcome Measure 5

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) ]
  Show Outcome Measure 6

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) ]
  Show Outcome Measure 7


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided


Responsible Party: GSK ( Study Director )
Study ID Numbers: FFU105924
Study First Received: October 2, 2007
Results First Received: November 14, 2008
Last Updated: September 29, 2009
ClinicalTrials.gov Identifier: NCT00539006     History of Changes
Health Authority: United States: Food and Drug Administration





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