Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00502775
First received: July 17, 2007
Last updated: August 20, 2009
Last verified: August 2009
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
Conditions: Allergic Rhinitis
Hayfever
Intervention: Drug: fluticasone furoate, fexofenadine

  Participant Flow
  Hide Participant Flow

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
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
  Hide Baseline Characteristics

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.
No text entered.

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  
Number of Participants  
[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
  Show All Outcome Measures

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
  Hide 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.


  More Information
  Hide More Information

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: 1-866-435-7343


No publications provided


Responsible Party: Study Director, GSK
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: August 20, 2009
Health Authority: United States: Food and Drug Administration