Trial Outcomes & Findings for 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 (NCT NCT01270958)

NCT ID: NCT01270958

Last Updated: 2014-08-06

Results Overview

Blood pressure (BP) is the pressure exerted by circulating blood upon the walls of blood vessels. During each heartbeat, BP varies between a maximum (systolic) and a minimum (diastolic) pressure.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 60 participants
• Primary outcome timeframe: 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)
• Results posted on: 2014-08-06

Participant Flow

Participant milestones

Measure	Fluticasone Furoate 110 mcg Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
Overall Study STARTED	60
Overall Study COMPLETED	56
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Fluticasone Furoate 110 mcg Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
Overall Study Lost to Follow-up	2
Overall Study Did not meet inclusion criteria for age	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Fluticasone Furoate 110 mcg n=60 Participants Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
Age, Continuous	35.5 Years STANDARD_DEVIATION 11.5 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants
Race/Ethnicity, Customized Vietnamese	60 participants n=5 Participants
Race/Ethnicity, Customized Other	0 participants n=5 Participants

PRIMARY outcome

Timeframe: 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)

Population: Intent-to-Treat (ITT) Population: all participants who received at least one dose of study drug. Some participants were lost to follow-up and may not have been dosed with study drug.

Blood pressure (BP) is the pressure exerted by circulating blood upon the walls of blood vessels. During each heartbeat, BP varies between a maximum (systolic) and a minimum (diastolic) pressure.

Outcome measures

Measure	Fluticasone Furoate 110 mcg n=56 Participants Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
Systolic Blood Pressure at Screening/Visit 1, Visit 2, and Visit 3 Screening/Visit 1	110.98 millimeters of mercury (mmHg) Standard Deviation 9.23
Systolic Blood Pressure at Screening/Visit 1, Visit 2, and Visit 3 Visit 2	110.63 millimeters of mercury (mmHg) Standard Deviation 11.69
Systolic Blood Pressure at Screening/Visit 1, Visit 2, and Visit 3 Visit 3	110.00 millimeters of mercury (mmHg) Standard Deviation 11.61

PRIMARY outcome

Timeframe: 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)

Population: ITT Population: Some participants were lost to follow-up and may not have been dosed with study drug.

Blood pressure (BP) is the pressure exerted by circulating blood upon the walls of blood vessels. During each heartbeat, BP varies between a maximum (systolic) and a minimum (diastolic) pressure.

Outcome measures

Measure	Fluticasone Furoate 110 mcg n=56 Participants Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
Diastolic Blood Pressure at Screening/Visit 1, Visit 2, and Visit 3 Screening/Visit 1	70.36 mmHg Standard Deviation 6.6
Diastolic Blood Pressure at Screening/Visit 1, Visit 2, and Visit 3 Visit 2	71.79 mmHg Standard Deviation 6.37
Diastolic Blood Pressure at Screening/Visit 1, Visit 2, and Visit 3 Visit 3	70.63 mmHg Standard Deviation 6.69

PRIMARY outcome

Timeframe: 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)

Population: ITT Population

Heart rate is measured as the number of heart beats per unit time.

Outcome measures

Measure	Fluticasone Furoate 110 mcg n=56 Participants Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
Heart Rate at Screening/Visit 1, Visit 2, and Visit 3 Screening/Visit 1	72.80 beats per minute (bpm) Standard Deviation 7.70
Heart Rate at Screening/Visit 1, Visit 2, and Visit 3 Visit 2	73.95 beats per minute (bpm) Standard Deviation 6.39
Heart Rate at Screening/Visit 1, Visit 2, and Visit 3 Visit 3	73.04 beats per minute (bpm) Standard Deviation 6.61

PRIMARY outcome

Timeframe: Baseline and treatment completion (up to Week 6)

Population: ITT Population

Hemoglobin functions primarily to transport oxygen from the lungs to the body tissues. Normal range: 125-160 grams per liter (g/L).

Outcome measures

Measure	Fluticasone Furoate 110 mcg n=56 Participants Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
Hemoglobin Values at Baseline and After Treatment Completion Baseline	137.20 g/L Standard Deviation 12.06
Hemoglobin Values at Baseline and After Treatment Completion After treatment completion	136.16 g/L Standard Deviation 10.82

PRIMARY outcome

Timeframe: Baseline and treatment completion (up to Week 6)

Population: ITT Population

Hematocrit is the proportion of blood volume that is occupied by red blood cells. The hematocrit (Hct) is expressed as liter of red blood cells in liters of blood. Normal range: 0.35-0.50 Liter/Liter.

Outcome measures

Measure	Fluticasone Furoate 110 mcg n=56 Participants Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
Hematocrit Values at Baseline and After Treatment Completion Baseline	0.40 Liter/Liter Standard Deviation 0.03
Hematocrit Values at Baseline and After Treatment Completion After treatment completion	0.40 Liter/Liter Standard Deviation 0.03

PRIMARY outcome

Timeframe: Baseline and treatment completion (up to Week 6)

Population: ITT Population

Red blood cells are cells in the blood that are used to transport oxygen throughout the body. Normal range: 3.9-5.8 10^12 cells per liter (Tetra/L).

Outcome measures

Measure	Fluticasone Furoate 110 mcg n=56 Participants Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
Red Blood Cell Count at Baseline and After Treatment Completion Baseline	4.49 Tetra/L Standard Deviation 0.40
Red Blood Cell Count at Baseline and After Treatment Completion After treatment completion	4.45 Tetra/L Standard Deviation 0.36

PRIMARY outcome

Timeframe: Baseline and treatment completion (up to Week 6)

Population: ITT Population

White blood cells are cells of the immune system that defend the body against both infectious disease and foreign materials. Normal range: 4-10 10^9 cells per liter (Giga/L).

Outcome measures

Measure	Fluticasone Furoate 110 mcg n=56 Participants Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
White Blood Cell Count at Baseline and After Treatment Completion Baseline	7.29 Giga/L Standard Deviation 1.76
White Blood Cell Count at Baseline and After Treatment Completion After treatment completion	7.08 Giga/L Standard Deviation 1.32

PRIMARY outcome

Timeframe: Baseline and treatment completion (up to Week 6)

Population: ITT Population

Platelets are cells found in the blood that play a role in blood clotting. Normal range: 150-400 Giga/L.

Outcome measures

Measure	Fluticasone Furoate 110 mcg n=56 Participants Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
Platelet Count at Baseline and After Treatment Completion Baseline	259.80 Giga/L Standard Deviation 59.02
Platelet Count at Baseline and After Treatment Completion After treatment completion	255.16 Giga/L Standard Deviation 49.57

PRIMARY outcome

Timeframe: Baseline and treatment completion (up to Week 6)

Population: ITT Population

Sodium is the major positive ion (cation) found outside of cells. The balance of the electrolytes in our bodies is essential for normal function of our cells and our organs. Normal range: 135-145 millimoles per liter (mmol/L).

Outcome measures

Measure	Fluticasone Furoate 110 mcg n=56 Participants Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
Sodium Count at Baseline and After Treatment Completion Baseline	138.09 mmol/L Standard Deviation 1.58
Sodium Count at Baseline and After Treatment Completion After treatment completion	139.13 mmol/L Standard Deviation 1.95

PRIMARY outcome

Timeframe: Baseline and treatment completion (up to Week 6)

Population: ITT Population

Potassium is the major positive ion (cation) found inside of cells. The balance of the electrolytes in our bodies is essential for normal function of our cells and our organs. Normal range: 3.5-5.0 mmol/L.

Outcome measures

Measure	Fluticasone Furoate 110 mcg n=56 Participants Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
Potassium Count at Baseline and After Treatment Completion Baseline	3.84 mmol/L Standard Deviation 0.27
Potassium Count at Baseline and After Treatment Completion After treatment completion	3.90 mmol/L Standard Deviation 0.02

PRIMARY outcome

Timeframe: Baseline and treatment completion (up to Week 6)

Population: ITT Population

Total bilirubin is formed when hemoglobin breaks down. Bilirubin is excreted in bile and urine, and elevated levels may indicate certain diseases. Normal range: <=17 micromoles per liter (umol/L).

Outcome measures

Measure	Fluticasone Furoate 110 mcg n=56 Participants Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
Total Bilirubin Value at Baseline and After Treatment Completion Baseline	11.91 umol/L Standard Deviation 3.74
Total Bilirubin Value at Baseline and After Treatment Completion After treatment completion	13.54 umol/L Standard Deviation 12.39

PRIMARY outcome

Timeframe: Baseline and treatment completion (up to Week 6)

Population: ITT Population

Creatinine is a metabolic waste product in urine that remains relatively constant in an individual and that may be used to establish baseline renal function. Normal range: 53-100 umol/L (female) and 62-120 umol/L (male).

Outcome measures

Measure	Fluticasone Furoate 110 mcg n=56 Participants Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
Creatinine Value at Baseline and After Treatment Completion Baseline	90.21 umol/L Standard Deviation 12.00
Creatinine Value at Baseline and After Treatment Completion After treatment completion	89.71 umol/L Standard Deviation 15.21

PRIMARY outcome

Timeframe: Baseline and treatment completion (up to Week 6)

Population: ITT Population

Alkaline phosphatase is an enzyme produced by the liver or bone. An elevated level of alkaline phosphatase in the blood may indicate a liver or bone problem. Normal range: 30-120 units per liter (U/L).

Outcome measures

Measure	Fluticasone Furoate 110 mcg n=56 Participants Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
Alkaline Phosphatase Value at Baseline and After Treatment Completion Baseline	73.05 U/L Standard Deviation 38.90
Alkaline Phosphatase Value at Baseline and After Treatment Completion After treatment completion	68.02 U/L Standard Deviation 18.53

PRIMARY outcome

Timeframe: Baseline and treatment completion (up to Week 6)

Population: ITT Population

AST is a liver enzyme released into the blood when certain organs or tissues, particularly the liver and heart, are injured. Normal range: <=37 U/L.

Outcome measures

Measure	Fluticasone Furoate 110 mcg n=56 Participants Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
Aspartate Aminotransferase (AST) Value at Baseline and After Treatment Completion Baseline	26.50 U/L Standard Deviation 6.48
Aspartate Aminotransferase (AST) Value at Baseline and After Treatment Completion After treatment completion	25.78 U/L Standard Deviation 4.18

PRIMARY outcome

Timeframe: Baseline and treatment completion (up to Week 6)

Population: ITT Population

ALT is a liver enzyme that plays a role in protein metabolism. Abnormally high blood levels of ALT are a sign of liver inflammation or damage from infection or drugs. Normal range: <=40 U/L.

Outcome measures

Measure	Fluticasone Furoate 110 mcg n=56 Participants Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
Alanine Aminotransferase (ALT) Value at Baseline and After Treatment Completion Baseline	26.57 U/L Standard Deviation 16.36
Alanine Aminotransferase (ALT) Value at Baseline and After Treatment Completion After treatment completion	24.29 U/L Standard Deviation 10.68

PRIMARY outcome

Timeframe: Baseline and treatment completion (up to Week 6)

Population: ITT Population

Glucose is a simple sugar used as a source of energy for cellular metabolism. Normal range: 3.9-6.4 mmol/L.

Outcome measures

Measure	Fluticasone Furoate 110 mcg n=56 Participants Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
Glucose Value at Baseline and After Treatment Completion Baseline	5.07 mmol/L Standard Deviation 0.59
Glucose Value at Baseline and After Treatment Completion After treatment completion	5.15 mmol/L Standard Deviation 0.53

PRIMARY outcome

Timeframe: Baseline and treatment completion (up to Week 6)

Population: ITT Population

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.

Outcome measures

Measure	Fluticasone Furoate 110 mcg n=56 Participants Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
Urea Nitrogen Value at Baseline and After Treatment Completion Baseline	5.78 mmol/L Standard Deviation 1.29
Urea Nitrogen Value at Baseline and After Treatment Completion After treatment completion	6.13 mmol/L Standard Deviation 1.40

PRIMARY outcome

Timeframe: Baseline and treatment completion (up to Week 6)

Population: ITT Population

A total protein assay measures the amount of proteins found in the plasma. Normal range: 65-82 g/L.

Outcome measures

Measure	Fluticasone Furoate 110 mcg n=56 Participants Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
Total Protein Value at Baseline and After Treatment Completion Baseline	76.61 g/L Standard Deviation 4.15
Total Protein Value at Baseline and After Treatment Completion After treatment completion	76.89 g/L Standard Deviation 3.40

PRIMARY outcome

Timeframe: Baseline and treatment completion (up to Week 6)

Population: ITT Population

Albumin is a simple water-soluble protein found in many tissues and liquids. Normal range: 35-50 g/L.

Outcome measures

Measure	Fluticasone Furoate 110 mcg n=56 Participants Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
Albumin Value at Baseline and After Treatment Completion Baseline	44.95 g/L Standard Deviation 2.04
Albumin Value at Baseline and After Treatment Completion After treatment completion	45.22 g/L Standard Deviation 2.07

PRIMARY outcome

Timeframe: Baseline and treatment completion (up to Week 6)

Population: ITT Population

The electrocardiogram is a recording of the electrical activity of the heart as it undergoes excitation (depolarization) and recovery (polarization) to initiate each beat of the heart. Normal ECG readings show a slight flat-dip in between contractions and relaxations. An abnormal ECG is determined by comparing the results of an ECG graph with a standard or normal heart graph. If these flat-dips are not present, it may be an indication of a more serious problem.

Outcome measures

Measure	Fluticasone Furoate 110 mcg n=56 Participants Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
Number of Participants With Normal and Abnormal Electrocardiogram (ECG) Results at Baseline and at Treatment Completion Normal, Baseline	56 participants
Number of Participants With Normal and Abnormal Electrocardiogram (ECG) Results at Baseline and at Treatment Completion Abnormal, Baseline	0 participants
Number of Participants With Normal and Abnormal Electrocardiogram (ECG) Results at Baseline and at Treatment Completion Normal, At treatment completion	56 participants
Number of Participants With Normal and Abnormal Electrocardiogram (ECG) Results at Baseline and at Treatment Completion Abnormal, At treatment completion	0 participants

PRIMARY outcome

Timeframe: Baseline and treatment completion (up to Week 6)

Population: ITT Population

Nasal polyps are non cancerous growths occurring in the nose or sinuses. Nasal ulcers are a break in skin or mucous membrane with loss of surface tissue, disintegration and necrosis of epithelial tissue.

Outcome measures

Measure	Fluticasone Furoate 110 mcg n=56 Participants Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
Percentage of Participants With Appearance of Nasal Polyps and Nasal Ulcers at Baseline and at Treatment Completion Baseline, nasal polyps	0 percentage of participants
Percentage of Participants With Appearance of Nasal Polyps and Nasal Ulcers at Baseline and at Treatment Completion After treatment completion, nasal polyps	0 percentage of participants
Percentage of Participants With Appearance of Nasal Polyps and Nasal Ulcers at Baseline and at Treatment Completion Baseline, nasal ulcers	0 percentage of participants
Percentage of Participants With Appearance of Nasal Polyps and Nasal Ulcers at Baseline and at Treatment Completion After treatment completion, nasal ulcers	0 percentage of participants

Adverse Events

Fluticasone Furoate 110 mcg

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Fluticasone Furoate 110 mcg n=56 participants at risk Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
General disorders Headache	1.8% 1/56 • During treatment period and a phone call questioning participants about adverse events 3-5 days after the end of study treatment (up to week 7) Serious adverse events (SAEs) and adverse events (AEs) were collected in the ITT Population.
Nervous system disorders Migraine	1.8% 1/56 • During treatment period and a phone call questioning participants about adverse events 3-5 days after the end of study treatment (up to week 7) Serious adverse events (SAEs) and adverse events (AEs) were collected in the ITT Population.
Reproductive system and breast disorders Menorrhagia	1.8% 1/56 • During treatment period and a phone call questioning participants about adverse events 3-5 days after the end of study treatment (up to week 7) Serious adverse events (SAEs) and adverse events (AEs) were collected in the ITT Population.
General disorders Fatigue	1.8% 1/56 • During treatment period and a phone call questioning participants about adverse events 3-5 days after the end of study treatment (up to week 7) Serious adverse events (SAEs) and adverse events (AEs) were collected in the ITT Population.
General disorders Sleepy	1.8% 1/56 • During treatment period and a phone call questioning participants about adverse events 3-5 days after the end of study treatment (up to week 7) Serious adverse events (SAEs) and adverse events (AEs) were collected in the ITT Population.
Ear and labyrinth disorders Ear pain	1.8% 1/56 • During treatment period and a phone call questioning participants about adverse events 3-5 days after the end of study treatment (up to week 7) Serious adverse events (SAEs) and adverse events (AEs) were collected in the ITT Population.
Respiratory, thoracic and mediastinal disorders Dry nose	1.8% 1/56 • During treatment period and a phone call questioning participants about adverse events 3-5 days after the end of study treatment (up to week 7) Serious adverse events (SAEs) and adverse events (AEs) were collected in the ITT Population.
Renal and urinary disorders Burning urination	1.8% 1/56 • During treatment period and a phone call questioning participants about adverse events 3-5 days after the end of study treatment (up to week 7) Serious adverse events (SAEs) and adverse events (AEs) were collected in the ITT Population.
Eye disorders Eyelid swelling	1.8% 1/56 • During treatment period and a phone call questioning participants about adverse events 3-5 days after the end of study treatment (up to week 7) Serious adverse events (SAEs) and adverse events (AEs) were collected in the ITT Population.
Respiratory, thoracic and mediastinal disorders Sore throat	1.8% 1/56 • During treatment period and a phone call questioning participants about adverse events 3-5 days after the end of study treatment (up to week 7) Serious adverse events (SAEs) and adverse events (AEs) were collected in the ITT Population.
Respiratory, thoracic and mediastinal disorders Itchy nose	1.8% 1/56 • During treatment period and a phone call questioning participants about adverse events 3-5 days after the end of study treatment (up to week 7) Serious adverse events (SAEs) and adverse events (AEs) were collected in the ITT Population.
Respiratory, thoracic and mediastinal disorders Sneeze	1.8% 1/56 • During treatment period and a phone call questioning participants about adverse events 3-5 days after the end of study treatment (up to week 7) Serious adverse events (SAEs) and adverse events (AEs) were collected in the ITT Population.
Respiratory, thoracic and mediastinal disorders Congested nose	1.8% 1/56 • During treatment period and a phone call questioning participants about adverse events 3-5 days after the end of study treatment (up to week 7) Serious adverse events (SAEs) and adverse events (AEs) were collected in the ITT Population.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER