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Dose Finding Study of Fluticasone Furoate Nasal Spray for Uncomplicated Acute Rhinosinusitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01018030
First Posted: November 23, 2009
Last Update Posted: May 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
Results First Submitted: March 17, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Sinusitis, Acute
Interventions: Drug: FFNS 110 mcg QD
Drug: FFNS 110 mcg BID
Drug: 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
Participants were randomized to a double-blind, placebo-controlled, parallel-group, 2-week treatment study to evaluate the safety and efficacy of fluticasone furoate nasal spray 110 micrograms (either once or twice daily) for the treatment of uncomplicated acute rhinosinusitis in adults and adolescent participants 12 years of age and older.

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 Vehicle Placebo Nasal Spray administered twice daily (BD) for 14 days
FFNS 110 mcg QD Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) administered once daily (QD) in the morning and vehicle placebo nasal spray administered in the evening for 14 days
FFNS 110 mcg BD FFNS 110 mcg administered BD for 14 days

Participant Flow:   Overall Study
    Placebo   FFNS 110 mcg QD   FFNS 110 mcg BD
STARTED   246   243   252 
COMPLETED   227   232   239 
NOT COMPLETED   19   11   13 
Adverse Event                10                5                5 
Withdrawal by Subject                2                2                4 
Lost to Follow-up                2                0                3 
Protocol Violation                2                1                0 
Physician Decision                1                0                1 
Lack of Efficacy                1                0                0 
Did Not Receive Study Drug                1                3                0 



  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 Vehicle Placebo Nasal Spray administered twice daily (BD) for 14 days
FFNS 110 mcg QD Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) administered once daily (QD) in the morning and vehicle placebo nasal spray administered in the evening for 14 days
FFNS 110 mcg BD FFNS 110 mcg administered BD for 14 days
Total Total of all reporting groups

Baseline Measures
   Placebo   FFNS 110 mcg QD   FFNS 110 mcg BD   Total 
Overall Participants Analyzed 
[Units: Participants]
 245   240   252   737 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 39.1  (14.81)   39.7  (15.64)   39.0  (16.02)   39.3  (15.48) 
[1] Baseline Characteristics were collected in the Intent-to-Treat 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 three participants in the FFNS 110 mcg QD group did not receive any study treatment.
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      143  58.4%      148  61.7%      169  67.1%      460  62.4% 
Male      102  41.6%      92  38.3%      83  32.9%      277  37.6% 
Race/Ethnicity, Customized 
[Units: Participants]
       
White   238   234   244   716 
Black   3   0   3   6 
Other (Other than White and Black)   4   6   5   15 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Change From Baseline in the Daily Major Symptom Score (MSS) Over the Entire Treatment Period (Weeks 1-2)   [ Time Frame: Baseline and entire treatment period (up to 2 weeks) ]

2.  Secondary:   First Time to Symptom Improvement   [ Time Frame: Entire treatment period (up to 2 weeks) ]

3.  Secondary:   Mean Change From Baseline Over the Entire Treatment Period in AM MSS   [ Time Frame: Baseline and entire treatment period (up to 2 weeks) ]

4.  Secondary:   Mean Change From Baseline Over the Entire Treatment Period in PM MSS   [ Time Frame: Baseline and entire treatment period (up to 2 weeks) ]

5.  Secondary:   Mean Change From Baseline Over the Entire Treatment Period in the Daily Nasal Congestion/Stuffiness Score   [ Time Frame: Baseline and entire treatment period (up to 2 weeks) ]

6.  Secondary:   Mean Change From Baseline Over the Entire Treatment Period in the AM Nasal Congestion/Stuffiness Score   [ Time Frame: Baseline and entire treatment period (up to 2 weeks) ]

7.  Secondary:   Mean Change From Baseline Over the Entire Treatment Period in the PM Nasal Congestion/Stuffiness Score   [ Time Frame: Baseline and entire treatment period (up to 2 weeks) ]

8.  Secondary:   Mean Change From Baseline Over the Entire Treatment Period in the Daily Sinus Headache/Pressure or Facial Pain/Pressure Score   [ Time Frame: Baseline and entire treatment period (up to 2 weeks) ]

9.  Secondary:   Mean Change From Baseline Over the Entire Treatment Period in the AM Sinus Headache/Pressure or Facial Pain/Pressure Score   [ Time Frame: Baseline and entire treatment period (up to 2 weeks) ]

10.  Secondary:   Mean Change From Baseline Over the Entire Treatment Period in the PM Sinus Headache/Pressure or Facial Pain/Pressure Score   [ Time Frame: Baseline and entire treatment period (up to 2 weeks) ]

11.  Secondary:   Mean Change From Baseline Over the Entire Treatment Period in the Daily Postnasal Drip Score   [ Time Frame: Baseline and entire treatment period (up to 2 weeks) ]

12.  Secondary:   Mean Change From Baseline Over the Entire Treatment Period in the AM Postnasal Drip Score   [ Time Frame: Baseline and entire treatment period (up to 2 weeks) ]

13.  Secondary:   Mean Change From Baseline Over the Entire Treatment Period in the PM Postnasal Drip Score   [ Time Frame: Baseline and entire treatment period (up to 2 weeks) ]

14.  Secondary:   Number of Participants Who Require the Use of an Antibiotic Due to the Development of Fulminant Bacterial Rhinosinusitis (FBRS)   [ Time Frame: 4 weeks ]


  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


Publications:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01018030     History of Changes
Other Study ID Numbers: 113203
First Submitted: November 19, 2009
First Posted: November 23, 2009
Results First Submitted: March 17, 2011
Results First Posted: April 12, 2011
Last Update Posted: May 17, 2017