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Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00502775
First received: July 17, 2007
Last updated: June 15, 2015
Last verified: June 2015
Results First Received: November 17, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Rhinitis, Allergic, Seasonal
Intervention: Drug: fluticasone furoate, fexofenadine

  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
Placebo No text entered.
Fluticasone Furoate 110mcg No text entered.
Fexofenadine 180 mg No text entered.

Participant Flow:   Overall Study
    Placebo   Fluticasone Furoate 110mcg   Fexofenadine 180 mg
STARTED   229   224   227 
COMPLETED   219   209   214 
NOT COMPLETED   10   15   13 
Adverse Event                1                2                1 
Protocol Violation                1                5                2 
Withdrawal by Subject                1                1                2 
Sponsor Terminated Study                1                0                1 
Non-compliance with eDiary                4                1                1 
Subject unable to swallow capsule                1                0                1 
Logpad compliance <80%                1                0                0 
Randomized in error                0                1                1 
Non-compliance                0                2                2 
Outside pollen area more than 48 hours                0                1                0 
Declining pollen counts                0                1                1 
Subject in jail                0                1                0 
Subject took disallowed drug                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
Placebo No text entered.
Fluticasone Furoate 110mcg No text entered.
Fexofenadine 180 mg No text entered.
Total Total of all reporting groups

Baseline Measures
   Placebo   Fluticasone Furoate 110mcg   Fexofenadine 180 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 229   224   227   680 
Age 
[Units: Years]
Mean (Standard Deviation)
 34.8  (12.71)   34.0  (13.55)   34.3  (13.66)   34.4  (13.29) 
Gender 
[Units: Number of Participants]
       
Female   139   152   135   426 
Male   90   72   92   254 
Race/Ethnicity, Customized 
[Units: Number of Participants]
       
White   181   189   181   551 
African American   40   29   42   111 
Other   8   6   4   18 


  Outcome Measures
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1.  Primary:   Mean Change From Baseline in the Nighttime Symptom Score (NSS)   [ Time Frame: Baseline and Weeks 1-2 ]

2.  Secondary:   Mean Change From Baseline in Nighttime Reflective Total Nasal Symptom Score (N-rTNSS)   [ Time Frame: Baseline and Weeks 1-2 ]

3.  Secondary:   Mean Change From Baseline in Daytime Reflective Total Nasal Symptom Score (D-rTNSS)   [ Time Frame: Baseline and Weeks 1-2 ]

4.  Secondary:   Mean Change From Baseline in 24 Hour Reflective Total Nasal Symptom Score (24 Hour rTNSS)   [ Time Frame: Baseline and Weeks 1-2 ]

5.  Secondary:   Mean Change From Baseline in Nighttime Reflective Total Ocular Symptom Score (N-rTOSS)   [ Time Frame: Baseline and Weeks 1-2 ]

6.  Secondary:   Mean Change From Baseline in Daytime Reflective Total Ocular Symptom Score (D-rTOSS)   [ Time Frame: Baseline and Weeks 1-2 ]

7.  Secondary:   Mean Change From Baseline in 24 Hour Reflective Total Ocular Symptoms Score (rTOSS)   [ Time Frame: Baseline and Weeks 1-2 ]

8.  Secondary:   Mean Change From Baseline in Pre-Dose Instantaneous Total Nasal Symptom Score (iTNSS)   [ Time Frame: Baseline and Weeks 1-2 ]

9.  Secondary:   Mean Change From Baseline in Pre-Dose Instantaneous Total Ocular Symptom Score (iTOSS)   [ Time Frame: Baseline and Weeks 1-2 ]

10.  Secondary:   Mean Change From Baseline in Morning Peak Nasal Inspiratory Flow (PNIF)   [ Time Frame: Baseline and Weeks 1-2 ]

11.  Secondary:   Mean Change From Baseline in Evening Peak Nasal Inspiratory Flow (PNIF)   [ Time Frame: Baseline and Weeks 1-2 ]

12.  Secondary:   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 ]


  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: NCT00502775     History of Changes
Other Study ID Numbers: FFU109047
Study First Received: July 17, 2007
Results First Received: November 17, 2008
Last Updated: June 15, 2015
Health Authority: United States: Food and Drug Administration