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

History of Changes

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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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) ]

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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) ]

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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) ]

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4. Primary:

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

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5. Primary:

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

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6. Primary:

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

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7. Primary:

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

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8. Primary:

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

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9. Primary:

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

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10. Primary:

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

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11. Primary:

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

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12. Primary:

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

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13. Primary:

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

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14. Primary:

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

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15. Primary:

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

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16. Primary:

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

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17. Primary:

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

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Measure Type	Primary
Measure Title	Urea Nitrogen Value at Baseline and After Treatment Completion
Measure Description	The urea concentration of serum or plasma, conventionally specified in terms of nitrogen content and called blood urea nitrogen (BUN), is an important indicator of renal function. Normal range: 2.5-7.5 mmol/L.
Time Frame	Baseline and treatment completion (up to Week 6)
Safety Issue	No

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.
ITT Population

Reporting Groups

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

Measured Values

	Fluticasone Furoate 110 Mcg
Number of Participants Analyzed [units: participants]	56
Urea Nitrogen Value at Baseline and After Treatment Completion [units: mmol/L] Mean ± Standard Deviation
Baseline	5.78 ± 1.29
After treatment completion	6.13 ± 1.40

Statistical Analysis 1 for Urea Nitrogen Value at Baseline and After Treatment Completion

Groups ^[1]	Fluticasone Furoate 110 Mcg
Method ^[2]	t-test, 2 sided
P Value ^[3]	>0.05

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
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[2]	Other relevant information, such as adjustments or degrees of freedom:
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[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Comparison between Screening value and Visit 3 value

18. Primary:

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

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19. Primary:

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

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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) ]

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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) ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

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
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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

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