A Pilot Study In Adults And Adolescents With Irritant (Non-Allergic) Rhinitis

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00730756
First received: February 27, 2008
Last updated: November 10, 2011
Last verified: November 2011
Results First Received: October 13, 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: Irritant (Non-Allergic) Rhinitis
Interventions: Drug: Fluticasone Furoate Nasal Spray
Other: 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 Vehicle placebo nasal spray once daily
FFNS 110 Mcg Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily

Participant Flow:   Overall Study
    Placebo     FFNS 110 Mcg  
STARTED     49     53  
COMPLETED     45     48  
NOT COMPLETED     4     5  
Adverse Event                 2                 0  
Lack of Efficacy                 1                 1  
Protocol Deviation                 1                 2  
Lost to Follow-up                 0                 1  
Withdrew Consent                 0                 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.
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Reporting Groups
  Description
Placebo Vehicle placebo nasal spray once daily
FFNS 110 Mcg Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
Total Total of all reporting groups

Baseline Measures
    Placebo     FFNS 110 Mcg     Total  
Number of Participants  
[units: participants]
  49     53     102  
Age [1]
[units: years]
Mean ± Standard Deviation
  35.9  ± 10.89     37.1  ± 12.78     36.6  ± 11.87  
Gender  
[units: participants]
     
Female     37     33     70  
Male     12     20     32  
Race/Ethnicity, Customized  
[units: participants]
     
Asian     49     53     102  
Total Nasal (TNSS) and Total Ocular (TOSS) Symptom Scores [2]
[units: points on a scale]
Mean ± Standard Deviation
     
Daily Reflective TNSS     6.4  ± 1.16     6.7  ± 1.25     6.5  ± 1.22  
Morning (AM) pre-dose instantaneous (i) TNSS     6.3  ± 1.50     6.5  ± 1.57     6.4  ± 1.53  
AM Reflective TNSS     6.4  ± 1.24     6.7  ± 1.36     6.5  ± 1.30  
Evening (PM) Reflective TNSS     6.3  ± 1.31     6.7  ± 1.32     6.5  ± 1.32  
Daily Reflective TOSS     2.4  ± 2.17     3.1  ± 2.27     2.8  ± 2.24  
AM pre-dose iTOSS     2.4  ± 2.24     3.1  ± 2.17     2.8  ± 2.22  
AM Reflective TOSS     2.4  ± 2.20     3.0  ± 2.16     2.7  ± 2.19  
PM Reflective TOSS     2.4  ± 2.19     3.2  ± 2.42     2.8  ± 2.34  
[1] Participants must have been 12 years of age or older.
[2] Total Symptom Scores (scale of 0-9; sum of the three individual nasal or ocular scores) based on 3 nasal symptoms (rhinorrhea, nasal congestion, and post-nasal drip) and 3 ocular symptoms (eye itching/burning, eye tearing/watering, and eye redness). Symptoms were evaluated on a scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe).



  Outcome Measures
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1.  Primary:   Mean Change From Baseline in Daily rTNSS Over the Entire Treatment Period (28 Days)   [ Time Frame: Baseline through Week 4 (28 days) ]

2.  Secondary:   Mean Change From Baseline in AM rTNSS, PM rTNSS, and AM Pre-dose iTNSS Over the Entire Treatment Period (28 Days)   [ Time Frame: Baseline through Week 4 (28 days) ]

3.  Secondary:   Mean Change From Baseline in Daily Reflective Individual Nasal Symptoms Score Over the Entire Treatment Period (28 Days)   [ Time Frame: Baseline through Week 4 (28 days) ]

4.  Secondary:   Mean Change From Baseline in AM Pre-dose Instantaneous Individual Nasal Symptoms Over the Entire Treatment Period (28 Days)   [ Time Frame: Baseline through Week 4 (28 days) ]

5.  Secondary:   Mean Change From Baseline in AM and PM Reflective Individual Nasal Symptoms Over the Entire Treatment Period (28 Days)   [ Time Frame: Baseline through Week 4 (28 days) ]

6.  Secondary:   Mean Change From Baseline in Total Ocular Symptoms Over the Entire Treatment Period (28 Days)   [ Time Frame: Baseline through Week 4 (28 days) ]

7.  Secondary:   Mean Change From Baseline in Daily Reflective Individual Ocular Symptoms Over the Entire Treatment Period (28 Days)   [ Time Frame: Baseline through Week 4 (28 days) ]

8.  Secondary:   Mean Change From Baseline in AM Pre-dose Instantaneous Individual Ocular Symptoms Over the Entire Treatment Period (28 Days)   [ Time Frame: Baseline through Week 4 (28 days) ]

9.  Secondary:   Mean Change From Baseline in AM and PM Reflective Individual Ocular Symptoms Over the Entire Treatment Period (28 Days)   [ Time Frame: Baseline through Week 4 (28 days) ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.  


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


No publications provided


Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00730756     History of Changes
Other Study ID Numbers: FFR111158
Study First Received: February 27, 2008
Results First Received: October 13, 2009
Last Updated: November 10, 2011
Health Authority: Thailand: Food and Drug Administration
United States: Food and Drug Administration