A Safety and Efficacy Study of Symbicort Turbuhaler Compa... | NCT01070784

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
1	Experimental		Drug: Symbicort Turbuhaler (Budesonide/formoterol)
2	Active Comparator		Drug: Drug: any available COPD treatment; investigator to decide

Name	Type	Description	Arm Group Labels	Other Names
Symbicort Turbuhaler (Budesonide/formoterol)	Drug	2 x 160/4.5 microgram, inhalation, bid, 52 weeks	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical Laboratory Test: Haematology -Erythrocytes	Mean change from Baseline	Baseline and 52 week after
Clinical Laboratory Test: Haematology -Haemoglobin	Change from baseline	Baseline and 52 week after
Clinical Laboratory Test: Haematology -Leucocytes	Change from baseline	Baseline and 52 week after
Clinical Laboratory Test: Haematology -Platelet Count	Change from baseline	Baseline and 52 week after
Clinical Laboratory Test: Haematology -Eosinophils	Change from baseline	Baseline and 52 week after
Clinical Laboratory Test: Haematology -Basophils	Change from baseline	Baseline and 52 week after
Clinical Laboratory Test: Haematology -Lymphocytes	Change from baseline	Baseline and 52 week after
Clinical Laboratory Test: Haematology -Monocytes	Change from baseline	Baseline and 52 week after

Secondary Outcomes

Measure	Description	Time Frame
Chronic Obstructive Pulmonary Disease (COPD) symptoms_Night-time Awakening	There are 5 alternatives (scored 0 to 4, 0= no awakening and 4 =did not sleep at all). The change from Run-in period average to Treatment period average for each treatment group	Daily during run-in period and daily during 52-week randomization treatment

Eligibility Module

Name	Affiliation	Role
Tomas Andersson, MD	AstraZeneca, R&D, Lund, Sweden	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Nagoya	Aichi-ken		Japan
Research Site

Label	URL
Related Info	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Symbicort Turbuhaler	Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
FG001	COPD Standard Therapy	Standard COPD treatment according to JRS guideline and GOLD guideline

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Symbicort Turbuhaler	Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
BG001	COPD Standard Therapy	Standard COPD treatment according to JRS guideline and GOLD guideline
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Full Range

Years

Title

Denominators

Categories

Title	Measurements
	OG000-7.6± 23.9 OG001-0.1± 22.9

Primary

Clinical Laboratory Test: Haematology -Haemoglobin

Change from baseline

Posted

Mean

Standard Deviation

g/dL

Baseline and 52 week after

ID	Title	Description
OG000	Arm 1 - Symbicort Turbuhaler	Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
OG001	Arm 2 - COPD Standard Therapy	Standard COPD treatment according to JRS guideline and GOLD guideline

Units	Counts
Participants	OG000

Primary

Clinical Laboratory Test: Haematology -Leucocytes

Change from baseline

Posted

Mean

Standard Deviation

/microliter(mcl)

Baseline and 52 week after

ID	Title	Description
OG000	Arm 1 - Symbicort Turbuhaler	Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
OG001	Arm 2 - COPD Standard Therapy	Standard COPD treatment according to JRS guideline and GOLD guideline

Units	Counts
Participants	OG000

Primary

Clinical Laboratory Test: Haematology -Platelet Count

Change from baseline

Posted

Mean

Standard Deviation

*10000/μl

Baseline and 52 week after

ID	Title	Description
OG000	Arm 1 - Symbicort Turbuhaler	Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
OG001	Arm 2 - COPD Standard Therapy	Standard COPD treatment according to JRS guideline and GOLD guideline

Units	Counts
Participants	OG000

Primary

Clinical Laboratory Test: Haematology -Eosinophils

Change from baseline

Posted

Mean

Standard Deviation

percentage of Eosinophils

Baseline and 52 week after

ID	Title	Description
OG000	Arm 1 - Symbicort Turbuhaler	Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
OG001	Arm 2 - COPD Standard Therapy	Standard COPD treatment according to JRS guideline and GOLD guideline

Units	Counts
Participants	OG000

Primary

Clinical Laboratory Test: Haematology -Basophils

Change from baseline

Posted

Mean

Standard Deviation

percentage of Basophils

Baseline and 52 week after

ID	Title	Description
OG000	Arm 1 - Symbicort Turbuhaler	Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
OG001	Arm 2 - COPD Standard Therapy	Standard COPD treatment according to JRS guideline and GOLD guideline

Units	Counts
Participants	OG000

Primary

Clinical Laboratory Test: Haematology -Lymphocytes

Change from baseline

Posted

Mean

Standard Deviation

percentage of Lymphocytes

Baseline and 52 week after

ID	Title	Description
OG000	Arm 1 - Symbicort Turbuhaler	Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
OG001	Arm 2 - COPD Standard Therapy	Standard COPD treatment according to JRS guideline and GOLD guideline

Units	Counts
Participants	OG000

Primary

Clinical Laboratory Test: Haematology -Monocytes

Change from baseline

Posted

Mean

Standard Deviation

percentage of Monocytes

Baseline and 52 week after

ID	Title	Description
OG000	Arm 1 - Symbicort Turbuhaler	Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
OG001	Arm 2 - COPD Standard Therapy	Standard COPD treatment according to JRS guideline and GOLD guideline

Units	Counts
Participants	OG000

Primary

Clinical Laboratory Test: Haematology -Neutrophils

Change from baseline

Posted

Mean

Standard Deviation

percentage of Neutrophils

Baseline and 52 week after

ID	Title	Description
OG000	Arm 1 - Symbicort Turbuhaler	Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
OG001	Arm 2 - COPD Standard Therapy	Standard COPD treatment according to JRS guideline and GOLD guideline

Units	Counts
Participants	OG000

Primary

Clinical Laboratory Test: Clinical Chemistry- S-Alanine Aminotransferase

Change from baseline

Posted

Mean

Standard Deviation

U/L

Baseline and 52 week after

ID	Title	Description
OG000	Arm 1 - Symbicort Turbuhaler	Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
OG001	Arm 2 - COPD Standard Therapy	Standard COPD treatment according to JRS guideline and GOLD guideline

Units	Counts
Participants	OG000

Primary

Clinical Laboratory Test: Clinical Chemistry- S-Aspartate Aminotransferase

Change from baseline

Posted

Mean

Standard Deviation

U/L

Baseline and 52 week after

ID	Title	Description
OG000	Arm 1 - Symbicort Turbuhaler	Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
OG001	Arm 2 - COPD Standard Therapy	Standard COPD treatment according to JRS guideline and GOLD guideline

Units	Counts
Participants	OG000

Primary

Clinical Laboratory Test: Clinical Chemistry- S-Alkaline Phosphatase (ALP)

Change from baseline

Posted

Mean

Standard Deviation

U/L

Baseline and 52 week after

ID	Title	Description
OG000	Arm 1 - Symbicort Turbuhaler	Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
OG001	Arm 2 - COPD Standard Therapy	Standard COPD treatment according to JRS guideline and GOLD guideline

Units	Counts
Participants	OG000

Primary

Clinical Laboratory Test: Clinical Chemistry- S-Creatinine

Change from baseline

Posted

Mean

Standard Deviation

mg/dL

Baseline and 52 week after

ID	Title	Description
OG000	Arm 1 - Symbicort Turbuhaler	Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
OG001	Arm 2 - COPD Standard Therapy	Standard COPD treatment according to JRS guideline and GOLD guideline

Units	Counts
Participants	OG000

Primary

Clinical Laboratory Test: Clinical Chemistry- S-Total Bilirubin

Change from baseline

Posted

Mean

Standard Deviation

mg/dL

Baseline and 52 week after

ID	Title	Description
OG000	Arm 1 - Symbicort Turbuhaler	Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
OG001	Arm 2 - COPD Standard Therapy	Standard COPD treatment according to JRS guideline and GOLD guideline

Units	Counts
Participants	OG000

Primary

Clinical Laboratory Test: Clinical Chemistry- S-Sodium

Change from baseline

Posted

Mean

Standard Deviation

mEq/L

Baseline and 52 week after

ID	Title	Description
OG000	Arm 1 - Symbicort Turbuhaler	Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
OG001	Arm 2 - COPD Standard Therapy	Standard COPD treatment according to JRS guideline and GOLD guideline

Units	Counts
Participants	OG000

Primary

Clinical Laboratory Test: Clinical Chemistry- S-Potassium

Change from baseline

Posted

Mean

Standard Deviation

mEq/L

Baseline and 52 week after

ID	Title	Description
OG000	Arm 1 - Symbicort Turbuhaler	Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
OG001	Arm 2 - COPD Standard Therapy	Standard COPD treatment according to JRS guideline and GOLD guideline

Units	Counts
Participants	OG000

Primary

Clinical Laboratory Test: Clinical Chemistry- S- Calcium

Change from baseline

Posted

Mean

Standard Deviation

mg/dL

Baseline and 52 week after

ID	Title	Description
OG000	Arm 1 - Symbicort Turbuhaler	Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
OG001	Arm 2 - COPD Standard Therapy	Standard COPD treatment according to JRS guideline and GOLD guideline

Units	Counts
Participants	OG000

Primary

Clinical Laboratory Test: Clinical Chemistry- S-Albumin

Change from baseline

Posted

Mean

Standard Deviation

g/dL

Baseline and 52 week after

ID	Title	Description
OG000	Arm 1 - Symbicort Turbuhaler	Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
OG001	Arm 2 - COPD Standard Therapy	Standard COPD treatment according to JRS guideline and GOLD guideline

Units	Counts
Participants	OG000

Primary

Clinical Laboratory Test: Clinical Chemistry- S-Protein, Total

Change from baseline

Posted

Mean

Standard Deviation

g/dL

Baseline and 52 week after

ID	Title	Description
OG000	Arm 1 - Symbicort Turbuhaler	Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
OG001	Arm 2 - COPD Standard Therapy	Standard COPD treatment according to JRS guideline and GOLD guideline

Units	Counts
Participants	OG000

Primary

Clinical Laboratory Test: Clinical Chemistry- S-C-Reactive Protein

Change from baseline

Posted

Mean

Standard Deviation

mg/dL

Baseline and 52 week after

ID	Title	Description
OG000	Arm 1 - Symbicort Turbuhaler	Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
OG001	Arm 2 - COPD Standard Therapy	Standard COPD treatment according to JRS guideline and GOLD guideline

Units	Counts
Participants	OG000

Primary

Clinical Laboratory Test: Clinical Chemistry- S-Urea Nitrogen

Change from baseline

Posted

Mean

Standard Deviation

mg/dL

Baseline and 52 week after

ID	Title	Description
OG000	Arm 1 - Symbicort Turbuhaler	Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
OG001	Arm 2 - COPD Standard Therapy	Standard COPD treatment according to JRS guideline and GOLD guideline

Units	Counts
Participants	OG000

Primary

Vital Signs- Sitting Systolic Blood Pressure(SBP)

Change from baseline

Posted

Mean

Standard Deviation

mmHg

Baseline and 52 week after

ID	Title	Description
OG000	Arm 1 - Symbicort Turbuhaler	Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
OG001	Arm 2 - COPD Standard Therapy	Standard COPD treatment according to JRS guideline and GOLD guideline

Units	Counts
Participants	OG000

Primary

Vital Signs- Sitting Diastolic Blood Pressure(DBP)

Change from baseline

Posted

Mean

Standard Deviation

mmHg

Baseline and 52 week after

ID	Title	Description
OG000	Arm 1 - Symbicort Turbuhaler	Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
OG001	Arm 2 - COPD Standard Therapy	Standard COPD treatment according to JRS guideline and GOLD guideline

Units	Counts
Participants	OG000

Primary

Vital Signs- Pulse Rate

Change from baseline

Posted

Mean

Standard Deviation

beats/minute

Baseline and 52 week after

ID	Title	Description
OG000	Arm 1 - Symbicort Turbuhaler	Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
OG001	Arm 2 - COPD Standard Therapy	Standard COPD treatment according to JRS guideline and GOLD guideline

Units	Counts
Participants	OG000

Primary

ECG Variables - Heart Rate

Change from baseline

Posted

Mean

Standard Deviation

beats/minute

Baseline and 52 week after

ID	Title	Description
OG000	Arm 1 - Symbicort Turbuhaler	Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
OG001	Arm 2 - COPD Standard Therapy	Standard COPD treatment according to JRS guideline and GOLD guideline

Units	Counts
Participants	OG000

Primary

ECG Variables - QT Interval

Change from baseline

Posted

Mean

Standard Deviation

Baseline and 52 week after

ID	Title	Description
OG000	Arm 1 - Symbicort Turbuhaler	Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
OG001	Arm 2 - COPD Standard Therapy	Standard COPD treatment according to JRS guideline and GOLD guideline

Units	Counts
Participants	OG000

Primary

ECG Variables - QTcB Interval

Change from baseline

Posted

Mean

Standard Deviation

Baseline and 52 week after

ID	Title	Description
OG000	Arm 1 - Symbicort Turbuhaler	Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
OG001	Arm 2 - COPD Standard Therapy	Standard COPD treatment according to JRS guideline and GOLD guideline

Units	Counts
Participants	OG000

Primary

ECG Variables - QTcF Interval

Change from baseline

Posted

Mean

Standard Deviation

Baseline and 52 week after

ID	Title	Description
OG000	Arm 1 - Symbicort Turbuhaler	Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
OG001	Arm 2 - COPD Standard Therapy	Standard COPD treatment according to JRS guideline and GOLD guideline

Units	Counts
Participants	OG000

Primary

ECG Variables - RR Interval

Change from baseline

Posted

Mean

Standard Deviation

Baseline and 52 week after

ID	Title	Description
OG000	Arm 1 - Symbicort Turbuhaler	Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
OG001	Arm 2 - COPD Standard Therapy	Standard COPD treatment according to JRS guideline and GOLD guideline

Units	Counts
Participants	OG000

Secondary

Chronic Obstructive Pulmonary Disease (COPD) symptoms_Night-time Awakening

There are 5 alternatives (scored 0 to 4, 0= no awakening and 4 =did not sleep at all). The change from Run-in period average to Treatment period average for each treatment group

Posted

Mean

Standard Deviation

units on a scale

Daily during run-in period and daily during 52-week randomization treatment

ID	Title	Description
OG000	Arm 1 - Symbicort Turbuhaler	Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
OG001	Arm 2 - COPD Standard Therapy	Standard COPD treatment according to JRS guideline and GOLD guideline

Units	Counts
Participants	OG000

Secondary

Chronic Obstructive Pulmonary Disease (COPD) symptoms_Breathlessness

There are 5 alternatives (scored 0 to 4, 0= unaware of any difficulty and 4 =almost constant, present even when resting). The change from Run-in period average to Treatment period average for each treatment group

Posted

Mean

Standard Deviation

units on a scale

Daily during run-in period and daily during 52-week randomization treatment

ID	Title	Description
OG000	Arm 1 - Symbicort Turbuhaler	Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
OG001	Arm 2 - COPD Standard Therapy	Standard COPD treatment according to JRS guideline and GOLD guideline

Units	Counts
Participants	OG000

Secondary

Chronic Obstructive Pulmonary Disease (COPD) symptoms_cough

There are 5 alternatives (scored 0 to 4, 0= unaware of coughing, 4= never free of cough or need to cough). The change from Run-in period average to Treatment period average for each treatment group

Posted

Mean

Standard Deviation

units on a scale

Daily during run-in period and daily during 52-week randomization treatment

ID	Title	Description
OG000	Arm 1 - Symbicort Turbuhaler	Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
OG001	Arm 2 - COPD Standard Therapy	Standard COPD treatment according to JRS guideline and GOLD guideline

Units	Counts
Participants	OG000

Secondary

Forced Expiratory Volume in 1 Second (FEV1) Measured With the Spirometer at the Clinic

The ratio of the average value of available data for Weeks 0, 4, 8, 17, 26, 34, 43 and 52 to the baseline for each treatment group. Ratio is being reported as a percentage in this Measure.

Posted

Geometric Mean

Full Range

percentage of Baseline

Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization

ID	Title	Description
OG000	Arm 1 - Symbicort Turbuhaler	Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
OG001	Arm 2 - COPD Standard Therapy	Standard COPD treatment according to JRS guideline and GOLD guideline

Units	Counts
Participants	OG000

Secondary

Forced Vital Capacity (FVC) Measured With the Spirometer at the Clinic

The ratio of the average value of available data for Weeks 0, 4, 8, 17, 26, 34, 43 and 52 to the baseline for each treatment group. Ratio is being reported as a percentage in this Measure.

Posted

Geometric Mean

Full Range

percentage of Baseline

Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization

ID	Title	Description
OG000	Arm 1 - Symbicort Turbuhaler	Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
OG001	Arm 2 - COPD Standard Therapy	Standard COPD treatment according to JRS guideline and GOLD guideline

Units	Counts
Participants	OG000

Secondary

Time to First COPD Exacerbation

A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as worsening in COPD symptoms requiring treatment with either a course of systemic steroid or hospitalisation. The percentage of participants who had experienced COPD exacerbation at the end of the study for each treatment group.

Posted

Number

Percentage of participants

Daily during 52-week randomization treatment

ID	Title	Description
OG000	Arm 1 - Symbicort Turbuhaler	Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
OG001	Arm 2 - COPD Standard Therapy	Standard COPD treatment according to JRS guideline and GOLD guideline

Units	Counts
Participants	OG000

Secondary

Number of COPD Exacerbations Over the Study Treatment Period

A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as worsening in COPD symptoms requiring treatment with either a course of systemic steroid or hospitalisation. Number of COPD exacerbation during 52-week randomization treatment

Posted

Number

event

Daily during 52-week randomization treatment

ID	Title	Description
OG000	Arm 1 - Symbicort Turbuhaler	Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
OG001	Arm 2 - COPD Standard Therapy	Standard COPD treatment according to JRS guideline and GOLD guideline

Units	Counts
Participants	OG000

Secondary

Rescue Medication Use

The change from run-in period and daily during 52-week randomization treatment

Posted

Mean

Standard Deviation

innhalation/day

Daily during 52-week randomization treatment

ID	Title	Description
OG000	Arm 1 - Symbicort Turbuhaler	Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
OG001	Arm 2 - COPD Standard Therapy	Standard COPD treatment according to JRS guideline and GOLD guideline

Units	Counts
Participants	OG000

Secondary

Health Related Quality of Life (HRQL) Based on the St. George's Respiratory Questionnaire (SGRQ)

The change from run-in period and daily during 52-week randomization treatment average for each treatment group. The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life).

Posted

Mean

Standard Deviation

units on a scale

Daily during run-in period and daily 52-week randomization treatment

ID	Title	Description
OG000	Arm 1 - Symbicort Turbuhaler	Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
OG001	Arm 2 - COPD Standard Therapy	Standard COPD treatment according to JRS guideline and GOLD guideline

Units	Counts
Participants	OG000

Secondary

Morning Peak Expiratory Flow (PEF) Measured at Home

The change from Run-in period average to 52-week randomization Treatment period average for each treatment group

Posted

Mean

Standard Deviation

Liter/minute(L/min)

Daily during run-in period and daily 52-week randomization treatment

ID	Title	Description
OG000	Arm 1 - Symbicort Turbuhaler	Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
OG001	Arm 2 - COPD Standard Therapy	Standard COPD treatment according to JRS guideline and GOLD guideline

Units	Counts
Participants	OG000

Secondary

Evening Peak Expiratory Flow (PEF) Measured at Home

The change from Run-in period average to 52-week randomization Treatment period average for each treatment group

Posted

Mean

Standard Deviation

Liter/minute(L/min)

Daily during run-in period and daily 52-week randomization treatment

ID	Title	Description
OG000	Arm 1 - Symbicort Turbuhaler	Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
OG001	Arm 2 - COPD Standard Therapy	Standard COPD treatment according to JRS guideline and GOLD guideline

Units	Counts
Participants	OG000

Secondary

Morning FEV1 Measured by the Subjects at Home

The change from run-in period and daily during 52-week randomization treatment

Posted

Mean

Standard Deviation

Liter(L)

Daily during run-in period and daily 52-week randomization treatment

ID	Title	Description
OG000	Arm 1 - Symbicort Turbuhaler	Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
OG001	Arm 2 - COPD Standard Therapy	Standard COPD treatment according to JRS guideline and GOLD guideline

Units	Counts
Participants	OG000

Secondary

Evening FEV1 Measured by the Subjects at Home

The change from run-in period and daily during 52-week randomization treatment

Posted

Mean

Standard Deviation

Liter(L)

Daily during run-in period and daily 52-week randomization treatment

ID	Title	Description
OG000	Arm 1 - Symbicort Turbuhaler	Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
OG001	Arm 2 - COPD Standard Therapy	Standard COPD treatment according to JRS guideline and GOLD guideline

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Symbicort Turbuhaler	Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily			25	130	75	130
EG001	COPD Standard Therapy	Standard COPD treatment according to JRS guideline and GOLD guideline			34	130	72	130

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Arteriosclerosis Obliterans	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected130 at risk EG0011 affected130 at risk
Prostatitis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected130 at risk EG0010 affected130 at risk
Benign Prostatic Hyperplasia	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected130 at risk EG0010 affected130 at risk
Haematuria	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected130 at risk EG0010 affected130 at risk
Computerised Tomogram Thorax Abnormal	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected130 at risk EG0011 affected130 at risk
Pyrexia	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected130 at risk EG0010 affected130 at risk
Inguinal Hernia	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected130 at risk EG0011 affected130 at risk
Intervertebral Disc Protrusion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected130 at risk EG0010 affected130 at risk
Synovial Cyst	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected130 at risk EG0010 affected130 at risk
Optic Ischaemic Neuropathy	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected130 at risk EG0011 affected130 at risk
Angle Closure Glaucoma	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected130 at risk EG0011 affected130 at risk
Cataract	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected130 at risk EG0012 affected130 at risk
Heat Illness	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected130 at risk EG0011 affected130 at risk
Tendon Rupture	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected130 at risk EG0010 affected130 at risk
Spinal Compression Fracture	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected130 at risk EG0010 affected130 at risk
Syncope	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected130 at risk EG0010 affected130 at risk
Loss Consciousness	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected130 at risk EG0010 affected130 at risk
Cerebral Infarction	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected130 at risk EG0010 affected130 at risk
Prostate Cancer	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected130 at risk EG0011 affected130 at risk
Gastric Adenoma	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1		EG0001 affected130 at risk EG0010 affected130 at risk
Laryngeal Cancer	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected130 at risk EG0011 affected130 at risk
Lung Neoplasm Malignant	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected130 at risk EG0011 affected130 at risk
Pulmonary Tuberculosis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected130 at risk EG0012 affected130 at risk
Bronchitis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1		EG0001 affected130 at risk EG0012 affected130 at risk
Pneumonia Bacterial	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected130 at risk EG0015 affected130 at risk
Pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0006 affected130 at risk EG0015 affected130 at risk
Organising Pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected130 at risk EG0011 affected130 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected130 at risk EG0011 affected130 at risk
Chronic Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected130 at risk EG0011 affected130 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 affected130 at risk EG0011 affected130 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected130 at risk EG0010 affected130 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0008 affected130 at risk EG00120 affected130 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Insomnia	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0007 affected130 at risk EG0011 affected130 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0007 affected130 at risk EG0011 affected130 at risk
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0007 affected130 at risk EG0017 affected130 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0006 affected130 at risk EG00110 affected130 at risk
Constipation	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00010 affected130 at risk EG00113 affected130 at risk
Pneumonia	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0009 affected130 at risk EG0013 affected130 at risk
Pharyngitis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0009 affected130 at risk EG0013 affected130 at risk
Bronchitis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG00015 affected130 at risk EG00113 affected130 at risk
Nasopharyngitis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG00055 affected130 at risk EG00151 affected130 at risk

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D000069502	Budesonide, Formoterol Fumarate Drug Combination
D019819	Budesonide
D000068759	Formoterol Fumarate

ID	Term
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals
D000588	Amines
D011282	Pregnenediones
D011283	Pregnenes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D004338	Drug Combinations
D004364	Pharmaceutical Preparations