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A Clinical Study To Test A Nasal Spray (Fluticasone Furoate Nasal Spray) For The Treatment Of Perennial (Year-round) Allergic Rhinitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00609674
First received: January 24, 2008
Last updated: August 21, 2014
Last verified: February 2011
Results First Received: June 22, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Rhinitis, Allergic, Perennial
Interventions: Drug: Fluticasone furoate nasal spray
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
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Reporting Groups
  Description
Placebo Placebo nasal spray
Fluticasone Furoate 110 mcg Once-daily fluticasone furoate (FF) nasal spray 110 mcg

Participant Flow:   Overall Study
    Placebo     Fluticasone Furoate 110 mcg  
STARTED     155     160  
COMPLETED     148     153  
NOT COMPLETED     7     7  
Adverse Event                 1                 1  
Protocol Violation                 3                 5  
Lost to Follow-up                 1                 0  
Withdrew consent                 2                 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.
No text entered.

Reporting Groups
  Description
Placebo Placebo nasal spray
Fluticasone Furoate 110 mcg Once-daily fluticasone furoate (FF) nasal spray 110 mcg
Total Total of all reporting groups

Baseline Measures
    Placebo     Fluticasone Furoate 110 mcg     Total  
Number of Participants  
[units: participants]
  155     160     315  
Age  
[units: years]
Mean ± Standard Deviation
  39.3  ± 15.06     38.1  ± 14.18     38.7  ± 14.61  
Gender  
[units: participants]
     
Female     45     57     102  
Male     110     103     213  
Race/Ethnicity, Customized  
[units: participants]
     
White     140     149     289  
African American/African Heritage     11     3     14  
American Indian/Alaska Native     0     2     2  
Asian     4     3     7  
Native Hawaiian/Other Pacific Islander     0     1     1  
African American/African Heritage & Asian & White     0     1     1  
Asian & White     0     1     1  



  Outcome Measures
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1.  Primary:   Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Nasal Symptom Scores (rTNSS)   [ Time Frame: Daily; Baseline through End of Study (Week 4) ]

2.  Secondary:   Mean Change From Baseline Over the Entire Treatment Period in Morning (AM), Pre-dose Instantaneous Total Nasal Symptom Score (iTNSS)   [ Time Frame: Daily; Baseline through End of Study (Week 4) ]

3.  Secondary:   Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Ocular Symptom Scores (rTOSS)   [ Time Frame: Daily; Baseline through End of Study (Week 4) ]

4.  Secondary:   Total Nasal Symptoms: Mean Change From Baseline Over the Entire Treatment Period in AM rTNSS   [ Time Frame: Daily; Baseline through End of Study (Week 4) ]

5.  Secondary:   Total Nasal Symptoms: Mean Change From Baseline Over the Entire Treatment Period in PM rTNSS   [ Time Frame: Daily; Baseline through End of Study (Week 4) ]

6.  Secondary:   Total Nasal Symptoms: Mean Percent Change From Baseline Over the Entire Treatment Period in Daily rTNSS and AM, Pre-dose iTNSS   [ Time Frame: Daily; Baseline through End of Study (Week 4) ]

7.  Secondary:   Individual Nasal Symptoms: Mean Change From Baseline Over the Entire Treatment Period in Individual Daily Reflective Nasal Symptom Scores and AM, Pre-dose Instantaneous Nasal Symptom Scores for Rhinorrhea, Nasal Congestion, Nasal Itching, and Sneezing   [ Time Frame: Daily; Baseline through End of Study (Week 4) ]

8.  Secondary:   Mean Change From Baseline Over the Entire Treatment Period in Both Individual AM Reflective and PM Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion, Nasal Itching, and Sneezing.   [ Time Frame: Daily; Baseline through End of Study (Week 4) ]

9.  Secondary:   Total Ocular Symptoms: Mean Change From Baseline Over the Entire Treatment Period in AM, Pre-dose Instantaneous Total Ocular Symptom Scores (iTOSS)   [ Time Frame: Daily; Baseline through End of Study (Week 4) ]

10.  Secondary:   Total Ocular Symptoms: Mean Change From Baseline Over the Entire Treatment Period in Both the AM Reflective Total Ocular Symptom Scores (rTOSS) and PM rTOSS   [ Time Frame: Daily; Baseline through End of Study (Week 4) ]

11.  Secondary:   Total Ocular Symptoms: Mean Percent Change From Baseline Over the Entire Treatment Period in Both the Daily rTOSS and the AM, Pre-dose iTOSS   [ Time Frame: Daily; Baseline through End of Study (Week 4) ]

12.  Secondary:   Individual Ocular Symptoms: Mean Change From Baseline Over the Entire Treatment Period in Both the Individual, Daily Reflective and the AM, Pre-dose Instantaneous Ocular Symptom Scores for Eyes Itching/Burning, Eyes Tearing/Watering, and Eye Redness.   [ Time Frame: Daily; Baseline through End of Study (Week 4) ]

13.  Secondary:   Mean Change From Baseline Over the Entire Treatment Period in Both the Individual AM Reflective and PM Reflective Ocular Symptom Scores for Eyes Itching/Burning, Eyes Tearing/Watering, and Eye Redness   [ Time Frame: Daily; Baseline through End of Study (Week 4) ]

14.  Secondary:   Peak Nasal Inspiratory Flow (PNIF): Mean Change From Baseline in Daily, AM, and PM PNIF   [ Time Frame: Daily; Baseline through End of Study (Week 4) ]

15.  Secondary:   Mean Change From Baseline to Endpoint in the Rhinoconjunctivitis Quality of Life Questionnaire With Standardised Activities (RQLQ[S])   [ Time Frame: Baseline and Week 4 ]


  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


No publications provided


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00609674     History of Changes
Other Study ID Numbers: FFU111439
Study First Received: January 24, 2008
Results First Received: June 22, 2009
Last Updated: August 21, 2014
Health Authority: United States: Food and Drug Administration