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Comparator Study Evaluating Patient Experience And Preference Of FFNS vs. FPNS

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00519636
First received: August 21, 2007
Last updated: November 21, 2012
Last verified: November 2012
Results First Received: November 7, 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 FFNS
Drug: placebo FPNS

  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
No text entered.

Reporting Groups
  Description
Fluticasone Furoate NS/Fluticasone Propionate NS Subjects who received Fluticasone Furoate Nasal Spray(FFNS)110 mcg 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 Subject who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
Fluticasone Propionate NS/Fluticasone Furoate NS Subjects 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 Subjects who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.

Participant Flow for 4 periods

Period 1:   Treatment Period 1
    Fluticasone Furoate NS/Fluticasone Propionate NS   Placebo FF/FP   Fluticasone Propionate NS/Fluticasone Furoate NS   Placebo FP/FF
STARTED   91   86   90   93 
COMPLETED   89   86   89   93 
NOT COMPLETED   2   0   1   0 
Adverse Event                1                0                1                0 
Sponsor request due to missed visit                1                0                0                0 

Period 2:   Washout Period
    Fluticasone Furoate NS/Fluticasone Propionate NS   Placebo FF/FP   Fluticasone Propionate NS/Fluticasone Furoate NS   Placebo FP/FF
STARTED   89   86   89   93 
COMPLETED   69   72   75   88 
NOT COMPLETED   20   14   14   5 
Adverse Event                2                1                1                0 
Lost to Follow-up                1                0                0                0 
Protocol Violation                0                0                1                2 
Withdrawal by Subject                1                0                1                0 
Failed to meet continuation criteria                14                11                9                3 
Out of pollen area > 48 hours                1                0                0                0 
Participating in study at another site                1                0                0                0 
Non-compliant                0                1                0                0 
Per doctors request                0                1                0                0 
Subject randomized in error                0                0                1                0 
Prohibited medications                0                0                1                0 

Period 3:   Treatment Period 2
    Fluticasone Furoate NS/Fluticasone Propionate NS   Placebo FF/FP   Fluticasone Propionate NS/Fluticasone Furoate NS   Placebo FP/FF
STARTED   69   72   75   88 
COMPLETED   69   71   74   86 
NOT COMPLETED   0   1   1   2 
Failed To Meet Continuation Criteria                0                0                0                1 
Subject randomized in error                0                1                0                0 
Per doctors request                0                0                1                0 
Subject misrandomized                0                0                0                1 

Period 4:   Post Study Period
    Fluticasone Furoate NS/Fluticasone Propionate NS   Placebo FF/FP   Fluticasone Propionate NS/Fluticasone Furoate NS   Placebo FP/FF
STARTED   69   71   74   86 
COMPLETED   69   71   74   85 
NOT COMPLETED   0   0   0   1 
Subject randomized in error                0                0                0                1 



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Fluticasone Furoate NS/Fluticasone Propionate NS Subjects who received Fluticasone Furoate Nasal Spray(FFNS)110 mcg 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 Subject who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
Fluticasone Propionate NS/Fluticasone Furoate NS Subjects 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 Subjects who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
Total Total of all reporting groups

Baseline Measures
   Fluticasone Furoate NS/Fluticasone Propionate NS   Placebo FF/FP   Fluticasone Propionate NS/Fluticasone Furoate NS   Placebo FP/FF   Total 
Overall Participants Analyzed 
[Units: Participants]
 91   86   90   93   360 
Age 
[Units: Years]
Mean (Standard Deviation)
 38.8  (12.25)   38  (11.54)   37.2  (12.55)   38.9  (11.39)   38.3  (11.91) 
Gender 
[Units: Participants]
         
Female   49   51   60   54   214 
Male   42   35   30   39   146 
Race/Ethnicity, Customized 
[Units: Participants]
         
African American/African Heritage   15   11   23   21   70 
American Indian or Alaska Native   1   0   0   0   1 
Asian: Central/South Asian Heritage   1   2   1   3   7 
Asian: Japanese/East-Southeast Asian Heritage   2   4   2   4   12 
Native Hawaiian or other Pacific Islander   2   1   0   1   4 
White   67   66   63   64   260 
African American/African Heritage & Asian   1   0   0   0   1 
African American/African Heritage & White   0   0   1   0   1 
Unknown   2   2   0   0   4 


  Outcome Measures
  Show All Outcome Measures

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

2.  Primary:   Subject 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) ]

3.  Secondary:   Comparation of Mean Change From Baseline Over Each Treatment Period 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) ]

4.  Secondary:   Comparision of Mean Change From Baseline Over Each Treatment Period 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) ]

5.  Secondary:   Subject Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) on Preference for: Leaking Out of Nose/Down Throat   [ Time Frame: End of Crossover Period (Day 22) ]

6.  Secondary:   Subject Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) on Preference for: Ease of Use   [ Time Frame: End of Crossover Period (Day 22) ]

7.  Secondary:   Subject Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) on Preference for: Gentleness of Mist   [ Time Frame: End of Crossover Period (Day 22) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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



Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00519636     History of Changes
Other Study ID Numbers: FFU105927
Study First Received: August 21, 2007
Results First Received: November 7, 2008
Last Updated: November 21, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration