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A Clinical Study With Fluticasone Furoate Nasal Spray And Vehicle Placebo For The Treatment Of Perennial (Year-round) Allergic Rhinitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00682643
First received: May 20, 2008
Last updated: March 15, 2012
Last verified: February 2012
History of Changes
Results First Received: December 8, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Rhinitis, Allergic, Perennial
Interventions: Drug: fluticasone furoate nasal spray
Other: Vechile Placebo nasal spray

  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 The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
FF 110 Mcg QD FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.

Participant Flow:   Overall Study
    Placebo     FF 110 Mcg QD  
STARTED     182     368  
COMPLETED     104     199  
NOT COMPLETED     78     169  
Adverse Event                 12                 23  
Lack of Efficacy                 2                 0  
Protocol Violation                 38                 76  
Met Protocol-defined Stopping Criteria                 3                 4  
Lost to Follow-up                 1                 6  
Physician Decision                 2                 6  
Withdrawal by Subject                 19                 53  
Did Not Receive Study Drug                 1                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Placebo The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
FF 110 Mcg QD FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
Total Total of all reporting groups

Baseline Measures
    Placebo     FF 110 Mcg QD     Total  
Number of Participants  
[units: participants]
 		  181     367     548  
Age [1]
[units: Years]
Mean ± Standard Deviation 		  38.0  ± 13.34     37.0  ± 13.48     37.4  ± 13.43  
Gender [1]
[units: Participants]
 		     
Female     116     255     371  
Male     65     112     177  
Race/Ethnicity, Customized [1]
[units: participants]
 		     
African American/African Heritage     29     50     79  
American Indian or Alaska Native     1     4     5  
Central/South Asian Heritage     0     1     1  
Japanese/East Asian/South East Asian Heritage     2     6     8  
Mixed Asian Heritage     0     1     1  
Native Hawaiian or other Pacific Islander     2     2     4  
White     146     303     449  
African American/African Heritage & White     1     0     1  
[1] Baseline Characteristics were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants who were randomized and received at least one dose of double-blind study drug. One participant in the placebo group and one participant in the FF 110 mcg QD group did not receive any study drug and were thus not included in the ITT Population.



  Outcome Measures
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1.  Primary:   Cumulative Proportion (CU) of Participants (Par.) With an Event, as Measured as a Percentage, for Posterior Subcapsular Opacity (P)   [ Time Frame: Baseline; Weeks 12, 24, 36, 52, 64, 76, 88, and 104 ]
  Show Outcome Measure 1

2.  Primary:   Cumulative Proportion of Participants, as Measured as a Percentage, With an Intraocular Pressure (IOP) Event   [ Time Frame: Baseline; Weeks 12, 24, 36, 52, 64, 76, 88, and 104 ]
  Show Outcome Measure 2

3.  Secondary:   Change From Baseline in LOCS III Posterior Subcapsular Opacity at Week 52 and Week 104   [ Time Frame: Baseline, Week 52, and Week 104 ]
  Show Outcome Measure 3

4.  Secondary:   Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104   [ Time Frame: Baseline, Week 52, and Week 104 ]
  Show Outcome Measure 4

5.  Secondary:   Change From Baseline in LOCS III Cortical Opacity (C) at Week 52 and Week 104   [ Time Frame: Baseline, Week 52, and Week 104 ]
  Show Outcome Measure 5

6.  Secondary:   Number of Participants With the Indicated Change From Baseline in Cortical Opacity by Increment Categories of >=0.3, >=0.5, and >=1.0 at Weeks 52 and 104   [ Time Frame: Baseline, Week 52, and Week 104 ]
  Show Outcome Measure 6

7.  Secondary:   Change From Baseline in LOCS III Nuclear Opacity (NO) at Week 52 and Week 104   [ Time Frame: Baseline, Week 52, and Week 104 ]
  Show Outcome Measure 7

8.  Secondary:   Change From Baseline in Nuclear Color (NC) at Week 52 and Week 104   [ Time Frame: Baseline, Week 52, and Week 104 ]
  Show Outcome Measure 8

9.  Secondary:   Change From Baseline in Intraocular Pressure (IOP) at Weeks 52 and 104   [ Time Frame: Baseline, Week 52, and Week 104 ]
  Show Outcome Measure 9

10.  Secondary:   Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52   [ Time Frame: Baseline and Week 52 ]
  Show Outcome Measure 10

11.  Secondary:   Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 104   [ Time Frame: Baseline and Week 104 ]
  Show Outcome Measure 11

12.  Secondary:   Change From Baseline in Logarithm of the Minimum Angle of Resolution (LogMAR) Visual Acuity (VA) Using Early Treatment Diabetic Retinopathy Study (ETDRS) Charts at Week 52 and Week 104   [ Time Frame: Baseline, Week 52, and Week 104 ]
  Show Outcome Measure 12

13.  Secondary:   Percent Change From Baseline in the Funduscopic Horizontal Cup-to-disc Ratio at Week 104   [ Time Frame: Baseline and Week 104 ]
  Show Outcome Measure 13

14.  Secondary:   Change From Baseline in the Daily Reflective Total Nasal Symptom Score (rTNSS) for the Indicated Study Periods   [ Time Frame: Baseline, Weeks 1 to 26, Weeks 27 to 52, Weeks 53 to 78, and Weeks 79 to 104 ]
  Show Outcome Measure 14


  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 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.


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


No publications provided


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00682643     History of Changes
Other Study ID Numbers: FFR110537
Study First Received: May 20, 2008
Results First Received: December 8, 2011
Last Updated: March 15, 2012
Health Authority: United States: Food and Drug Administration