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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01018030
First received: November 19, 2009
Last updated: June 20, 2013
Last verified: April 2011
Results First Received: March 17, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, 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  
Number of Participants  
[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  
Gender  
[units: Participants]
       
Female     143     148     169     460  
Male     102     92     83     277  
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  
[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.



  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


No publications provided


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01018030     History of Changes
Other Study ID Numbers: 113203
Study First Received: November 19, 2009
Results First Received: March 17, 2011
Last Updated: June 20, 2013
Health Authority: Estonia: State Agency of Medicines
Spain: Agencia Española del Medicamento y Productos Sanitarios
Germany: Land Authority for Health and Social Issues
Poland: URZAD REJESTRACJI PRODUKTOW LECZNICZYCH, WYROBOW MEDYCZNYCH I PRODUKTOW BIOBOJCZYCH
Ukraine: The Central Ethics Committee of Ministry of Health of Ukraine
Russia: Federal Service of Surveillance in Healthcare and Social development of Russian federation
Ukraine: State Pharmacological Center of Ministry of Health of Ukraine
Canada: Health Canada
Germany: Bundesinstitut für Arzneimittel und Medizinprodukte
Norway: National Health Services
Sweden: Medical Products Agency
Czech: State Institute for Drug Control
Bulgaria: Bulgarian Drug Agency (BDA)
Europe: European Medicines Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)