A Phase-IV, Open-label Study to Evaluate Safety/Tolerability of Once-daily AVAMYS (TM) Aqueous Nasal Spray 110mcg Among Vietnamese Adult Patients With Established Perennial Allergic Rhinitis (AVY-REG00108VN)

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01270958
First received: August 31, 2010
Last updated: December 9, 2010
Last verified: December 2010
Results First Received: October 28, 2010  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label
Conditions: Rhinitis, Allergic, Perennial
Perennial Allergic Rhinitis (PAR)
Intervention: Drug: Avamys aqueous nasal spray 110mcg

  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
Fluticasone Furoate 110 Mcg Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily

Participant Flow:   Overall Study
    Fluticasone Furoate 110 Mcg  
STARTED     60  
COMPLETED     56  
NOT COMPLETED     4  
Lost to Follow-up                 2  
Did not meet inclusion criteria for age                 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
Fluticasone Furoate 110 Mcg Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily

Baseline Measures
    Fluticasone Furoate 110 Mcg  
Number of Participants  
[units: participants]
  60  
Age  
[units: Years]
Mean ± Standard Deviation
  35.5  ± 11.5  
Gender  
[units: Participants]
 
Female     33  
Male     27  
Race/Ethnicity, Customized  
[units: participants]
 
Vietnamese     60  
Other     0  



  Outcome Measures
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1.  Primary:   Systolic Blood Pressure at Screening/Visit 1, Visit 2, and Visit 3   [ Time Frame: Screening/Visit 1 (3-5 days after Screening Visit), Visit 2 (14 [± 1] days after Visit 1, or Day 15), and Visit 3 (42 [± 1] days after Visit 1, or Day 43) ]

2.  Primary:   Diastolic Blood Pressure at Screening/Visit 1, Visit 2, and Visit 3   [ Time Frame: Screening/Visit 1 (3-5 days after Screening Visit), Visit 2 (14 [± 1] days after Visit 1, or Day 15), and Visit 3 (42 [± 1] days after Visit 1, or Day 43) ]

3.  Primary:   Heart Rate at Screening/Visit 1, Visit 2, and Visit 3   [ Time Frame: Screening/Visit 1 (3-5 days after Screening Visit), Visit 2 (14 [± 1] days after Visit 1, or Day 15), and Visit 3 (42 [± 1] days after Visit 1, or Day 43) ]

4.  Primary:   Hemoglobin Values at Baseline and After Treatment Completion   [ Time Frame: Baseline and treatment completion (up to Week 6) ]

5.  Primary:   Hematocrit Values at Baseline and After Treatment Completion   [ Time Frame: Baseline and treatment completion (up to Week 6) ]

6.  Primary:   Red Blood Cell Count at Baseline and After Treatment Completion   [ Time Frame: Baseline and treatment completion (up to Week 6) ]

7.  Primary:   White Blood Cell Count at Baseline and After Treatment Completion   [ Time Frame: Baseline and treatment completion (up to Week 6) ]

8.  Primary:   Platelet Count at Baseline and After Treatment Completion   [ Time Frame: Baseline and treatment completion (up to Week 6) ]

9.  Primary:   Sodium Count at Baseline and After Treatment Completion   [ Time Frame: Baseline and treatment completion (up to Week 6) ]

10.  Primary:   Potassium Count at Baseline and After Treatment Completion   [ Time Frame: Baseline and treatment completion (up to Week 6) ]

11.  Primary:   Total Bilirubin Value at Baseline and After Treatment Completion   [ Time Frame: Baseline and treatment completion (up to Week 6) ]

12.  Primary:   Creatinine Value at Baseline and After Treatment Completion   [ Time Frame: Baseline and treatment completion (up to Week 6) ]

13.  Primary:   Alkaline Phosphatase Value at Baseline and After Treatment Completion   [ Time Frame: Baseline and treatment completion (up to Week 6) ]

14.  Primary:   Aspartate Aminotransferase (AST) Value at Baseline and After Treatment Completion   [ Time Frame: Baseline and treatment completion (up to Week 6) ]

15.  Primary:   Alanine Aminotransferase (ALT) Value at Baseline and After Treatment Completion   [ Time Frame: Baseline and treatment completion (up to Week 6) ]

16.  Primary:   Glucose Value at Baseline and After Treatment Completion   [ Time Frame: Baseline and treatment completion (up to Week 6) ]

17.  Primary:   Urea Nitrogen Value at Baseline and After Treatment Completion   [ Time Frame: Baseline and treatment completion (up to Week 6) ]

18.  Primary:   Total Protein Value at Baseline and After Treatment Completion   [ Time Frame: Baseline and treatment completion (up to Week 6) ]

19.  Primary:   Albumin Value at Baseline and After Treatment Completion   [ Time Frame: Baseline and treatment completion (up to Week 6) ]

20.  Primary:   Number of Participants With Normal and Abnormal Electrocardiogram (ECG) Results at Baseline and at Treatment Completion   [ Time Frame: Baseline and treatment completion (up to Week 6) ]

21.  Primary:   Percentage of Participants With Appearance of Nasal Polyps and Nasal Ulcers at Baseline and at Treatment Completion   [ Time Frame: Baseline and treatment completion (up to Week 6) ]


  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: E.D. Derilus; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01270958     History of Changes
Other Study ID Numbers: 112185
Study First Received: August 31, 2010
Results First Received: October 28, 2010
Last Updated: December 9, 2010
Health Authority: Vietnam: Ministry of Health