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Once-Daily Investigational Nasal Spray In Adults And Adolescents With Vasomotor Rhinitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00118703
First Posted: July 12, 2005
Last Update Posted: August 21, 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 21, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Vasomotor Rhinitis
Rhinitis, Vasomotor
Intervention: Drug: GW685698X

  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
The actual dose delivered from the product was 27.5 micrograms (µg) /actuation, which is therefore proposed as the label claim rather than 25 µg/actuation. Based on this spray content assessment, the dose examined in this study was actually 110 µg rather than the 100 µg dose indicated in the protocol.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Males and females >=12 years of age, diagnosed with vasomotor rhinitis (VMR) and meeting the symptom requirements entered a 7 to 14 days screening period. Following screening period, participants meeting specified symptom criteria received treatment of either fluticasone furoate or placebo in 1:1 ratio up to 4 weeks.

Reporting Groups
  Description
Placebo Participants were instructed to self administer two sprays of placebo into each nostril once daily (QD) in the morning (ante meridian [AM]), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
Fluticasone Furoate 110 µg QD Participants were instructed to self administer two sprays of fluticasone furoate 110 µg into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.

Participant Flow:   Overall Study
    Placebo   Fluticasone Furoate 110 µg QD
STARTED   173   174 
COMPLETED   168   165 
NOT COMPLETED   5   9 
Protocol Violation                1                0 
Adverse Event                1                1 
Participant took two different treatment                0                1 
Withdrawal by Subject                2                5 
Lost to Follow-up                1                2 



  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 Participants were instructed to self administer two sprays of placebo into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
Fluticasone Furoate 110 µg QD Participants were instructed to self administer two sprays of fluticasone furoate 110 µg into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
Total Total of all reporting groups

Baseline Measures
   Placebo   Fluticasone Furoate 110 µg QD   Total 
Overall Participants Analyzed 
[Units: Participants]
 173   174   347 
Age 
[Units: Years]
Mean (Standard Deviation)
 44  (14.72)   43.8  (15.44)   43.9  (15.06) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      108  62.4%      124  71.3%      232  66.9% 
Male      65  37.6%      50  28.7%      115  33.1% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      1   0.6%      0   0.0%      1   0.3% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      7   4.0%      6   3.4%      13   3.7% 
White      164  94.8%      167  96.0%      331  95.4% 
More than one race      1   0.6%      1   0.6%      2   0.6% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Change From Baseline in Daily Reflective Total Nasal Symptom Scores (rTNSS)   [ Time Frame: Baseline and up to Week 4 ]

2.  Secondary:   Mean Change From Baseline in Morning (AM) Pre-dose Instantaneous Total Nasal Symptom Scores (iTNSS)   [ Time Frame: Baseline and up to Week 4 ]

3.  Secondary:   Number of Participants Based on Overall Evaluation of Response to Therapy   [ Time Frame: Week 4 (Day 29) or Early Withdrawal ]


  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



Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00118703     History of Changes
Other Study ID Numbers: FFR30007
First Submitted: July 1, 2005
First Posted: July 12, 2005
Results First Submitted: March 21, 2017
Results First Posted: May 2, 2017
Last Update Posted: August 21, 2017