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Study Results
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Comparator Study Evaluating Patient Preference Of FFNS vs. FPNS
This study has been completed.
Study NCT00539006   Information provided by GlaxoSmithKline

First Received on October 2, 2007.   Last Updated on December 15, 2011   History of Changes
Results First Received: November 14, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Rhinitis, Allergic, Perennial
Seasonal Allergic Rhinitis
Interventions: Drug: FPNS
Drug: FFNS
Drug: placebo FPNS
Drug: placebo FFNS

  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 1:   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 2:   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 3:   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 4:   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 5:   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   [ Time Frame: Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21) ]
  Show Outcome Measure 1

2.  Primary:   Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Scent/Odor   [ Time Frame: 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   [ Time Frame: 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   [ Time Frame: 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   [ Time Frame: 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   [ Time Frame: 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   [ Time Frame: 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: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00539006     History of Changes
Other Study ID Numbers: FFU105924
Study First Received: October 2, 2007
Results First Received: November 14, 2008
Last Updated: December 15, 2011
Health Authority: United States: Institutional Review Board;   United States: Food and Drug Administration





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