| Primary | Clinical Laboratory Test: Haematology -Erythrocytes | Mean change from Baseline | All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population. | Posted | | Mean | Standard Deviation | erythrocytes counts x10000/μl | | Baseline and week 52 | | | | ID | Title | Description |
|---|
| OG000 | Arm 1 - Formoterol | Formoterol 9 μg twice daily | | OG001 | Arm 2 - Standard Treatment | Standard COPD (JRS guideline and GOLD) treatment |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-6.25± 23.8
- OG001-5.2± 27.5
|
|
| |
| Primary | Clinical Laboratory Test: Haematology -Haemoglobin | | All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population. | Posted | | Mean | Standard Deviation | g/dL | | Baseline and week 52 | | | | ID | Title | Description |
|---|
| OG000 | Arm 1 - Formoterol | Formoterol 9 μg twice daily | | OG001 | Arm 2 - Standard Treatment | Standard COPD (JRS guideline and GOLD) treatment |
| |
| Primary | Clinical Laboratory Test: Haematology-Leucocytes | | All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population. | Posted | | Mean | Standard Deviation | leukocyte count/µL | | Baseline and week 52 | | | | ID | Title | Description |
|---|
| OG000 | Arm 1 - Formoterol | Formoterol 9 μg twice daily | | OG001 | Arm 2 - Standard Treatment | Standard COPD (JRS guideline and GOLD) treatment |
| |
| Primary | Clinical Laboratory Test: Haematology-Platelet Count | | All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population. | Posted | | Mean | Standard Deviation | Platelet Count x10000/μl | | Baseline and week 52 | | | | ID | Title | Description |
|---|
| OG000 | Arm 1 - Formoterol | Formoterol 9 μg twice daily | | OG001 | Arm 2 - Standard Treatment | Standard COPD (JRS guideline and GOLD) treatment |
| |
| Primary | Clinical Laboratory Test: Haematology Eosinophils | | All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population. | Posted | | Mean | Standard Deviation | percentage of Eosinophil | | baseline and week 52 | | | | ID | Title | Description |
|---|
| OG000 | Arm 1 - Formoterol | Formoterol 9 μg twice daily | | OG001 | Arm 2 - Standard Treatment | Standard COPD (JRS guideline and GOLD) treatment |
| |
| Primary | Clinical Laboratory Test: Haematology Basophil | | All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population. | Posted | | Mean | Standard Deviation | percentage of Basophil | | Baseline and week 52 | | | | ID | Title | Description |
|---|
| OG000 | Arm 1 - Formoterol | Formoterol 9 μg twice daily | | OG001 | Arm 2 - Standard Treatment | Standard COPD (JRS guideline and GOLD) treatment |
| |
| Primary | Clinical Laboratory Test: Haematology-Lymphocytes | | All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population. | Posted | | Mean | Standard Deviation | percentage of Lymphocyte | | Baseline and week 52 | | | | ID | Title | Description |
|---|
| OG000 | Arm 1 - Formoterol | Formoterol 9 μg twice daily | | OG001 | Arm 2 - Standard Treatment | Standard COPD (JRS guideline and GOLD) treatment |
| |
| Primary | Clinical Laboratory Test: Haematology-Monocytes | | All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population. | Posted | | Mean | Standard Deviation | percentage of Monocyte | | Baseline and week 52 | | | | ID | Title | Description |
|---|
| OG000 | Arm 1 - Formoterol | Formoterol 9 μg twice daily | | OG001 | Arm 2 - Standard Treatment | Standard COPD (JRS guideline and GOLD) treatment |
| |
| Primary | Clinical Laboratory Test: Haematology -Neutrophils | | All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population. | Posted | | Mean | Standard Deviation | percentage of Neutrophil | | Baseline and week 52 | | | | ID | Title | Description |
|---|
| OG000 | Arm 1 - Formoterol | Formoterol 9 μg twice daily | | OG001 | Arm 2 - Standard Treatment | Standard COPD (JRS guideline and GOLD) treatment |
| |
| Primary | Clinical Laboratory Test: Clinical Chemistry- S-Alanine Aminotransferase | | All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population. | Posted | | Mean | Standard Deviation | U/l | | Baseline and week 52 | | | | ID | Title | Description |
|---|
| OG000 | Arm 1 - Formoterol | Formoterol 9 μg twice daily | | OG001 | Arm 2 - Standard Treatment | Standard COPD (JRS guideline and GOLD) treatment |
| |
| Primary | Clinical Laboratory Test: Clinical Chemistry-S-Aspartate Aminotransferase | | All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population. | Posted | | Mean | Standard Deviation | U/l | | Baseline and week 52 | | | | ID | Title | Description |
|---|
| OG000 | Arm 1 - Formoterol | Formoterol 9 μg twice daily | | OG001 | Arm 2 - Standard Treatment | Standard COPD (JRS guideline and GOLD) treatment |
| |
| Primary | Clinical Laboratory Test: Clinical Chemistry-S-Alkaline Phosphatase (ALP) | | All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population. | Posted | | Mean | Standard Deviation | U/l | | Baseline and week 52 | | | | ID | Title | Description |
|---|
| OG000 | Arm 1 - Formoterol | Formoterol 9 μg twice daily | | OG001 | Arm 2 - Standard Treatment | Standard COPD (JRS guideline and GOLD) treatment |
| |
| Primary | Clinical Laboratory Test: Clinical Chemistry-S-Creatinine | | All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline and week 52 | | | | ID | Title | Description |
|---|
| OG000 | Arm 1 - Formoterol | Formoterol 9 μg twice daily | | OG001 | Arm 2 - Standard Treatment | Standard COPD (JRS guideline and GOLD) treatment |
| |
| Primary | Clinical Laboratory Test: Clinical Chemistry-S-Total Bilirubin | | All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline and week 52 | | | | ID | Title | Description |
|---|
| OG000 | Arm 1 - Formoterol | Formoterol 9 μg twice daily | | OG001 | Arm 2 - Standard Treatment | Standard COPD (JRS guideline and GOLD) treatment |
| |
| Primary | Clinical Laboratory Test: Clinical Chemistry-S-Sodium | | All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population. | Posted | | Mean | Standard Deviation | mEq/l | | Baseline and week 52 | | | | ID | Title | Description |
|---|
| OG000 | Arm 1 - Formoterol | Formoterol 9 μg twice daily | | OG001 | Arm 2 - Standard Treatment | Standard COPD (JRS guideline and GOLD) treatment |
| |
| Primary | Clinical Laboratory Test: Clinical Chemistry-S-Potassium | | All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population. | Posted | | Mean | Standard Deviation | mEq/L | | Baseline and week 52 | | | | ID | Title | Description |
|---|
| OG000 | Arm 1 - Formoterol | Formoterol 9 μg twice daily | | OG001 | Arm 2 - Standard Treatment | Standard COPD (JRS guideline and GOLD) treatment |
| |
| Primary | Clinical Laboratory Test: Clinical Chemistry-S- Calcium | | All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population. | Posted | | Mean | Standard Deviation | mg/dl | | Baseline and week 52 | | | | ID | Title | Description |
|---|
| OG000 | Arm 1 - Formoterol | Formoterol 9 μg twice daily | | OG001 | Arm 2 - Standard Treatment | Standard COPD (JRS guideline and GOLD) treatment |
| |
| Primary | Clinical Laboratory Test: Clinical Chemistry-S-Albumin | | All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population. | Posted | | Mean | Standard Deviation | g/dl | | Baseline and week 52 | | | | ID | Title | Description |
|---|
| OG000 | Arm 1 - Formoterol | Formoterol 9 μg twice daily | | OG001 | Arm 2 - Standard Treatment | Standard COPD (JRS guideline and GOLD) treatment |
| |
| Primary | Clinical Laboratory Test: Clinical Chemistry-S-Total Protein | | All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population. | Posted | | Mean | Standard Deviation | g/dl | | Baseline and week 52 | | | | ID | Title | Description |
|---|
| OG000 | Arm 1 - Formoterol | Formoterol 9 μg twice daily | | OG001 | Arm 2 - Standard Treatment | Standard COPD (JRS guideline and GOLD) treatment |
| |
| Primary | Clinical Laboratory Test: Clinical Chemistry - S-Blood Urea Nitrogen (BUN) | | All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population. | Posted | | Mean | Standard Deviation | mg/dl | | Baseline and week 52 | | | | ID | Title | Description |
|---|
| OG000 | Arm 1 - Formoterol | Formoterol 9 μg twice daily | | OG001 | Arm 2 - Standard Treatment | Standard COPD (JRS guideline and GOLD) treatment |
| |
| Primary | Vital Signs- Sitting SBP | | All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population. | Posted | | Mean | Standard Deviation | mmHg | | Baseline and week 52 | | | | ID | Title | Description |
|---|
| OG000 | Arm 1 - Formoterol | Formoterol 9 μg twice daily | | OG001 | Arm 2 - Standard Treatment | Standard COPD (JRS guideline and GOLD) treatment |
| |
| Primary | Vital Signs- Sitting DBP | | All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population. | Posted | | Mean | Standard Deviation | mmHg | | Baseline and week 52 | | | | ID | Title | Description |
|---|
| OG000 | Arm 1 - Formoterol | Formoterol 9 μg twice daily | | OG001 | Arm 2 - Standard Treatment | Standard COPD (JRS guideline and GOLD) treatment |
| |
| Primary | Vital Signs - Pulse Rate | | All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population. | Posted | | Mean | Standard Deviation | beats/minute | | Baseline and week 52 | | | | ID | Title | Description |
|---|
| OG000 | Arm 1 - Formoterol | Formoterol 9 μg twice daily | | OG001 | Arm 2 - Standard Treatment | Standard COPD (JRS guideline and GOLD) treatment |
| |
| Primary | ECG Variables - Heart Rate | | All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population. | Posted | | Mean | Standard Deviation | beats/min | | Baseline and week 52 | | | | ID | Title | Description |
|---|
| OG000 | Arm 1 - Formoterol | Formoterol 9 μg twice daily | | OG001 | Arm 2 - Standard Treatment | Standard COPD (JRS guideline and GOLD) treatment |
| |
| Primary | ECG Variables - QT Interval | | All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population. | Posted | | Mean | Standard Deviation | milisecond | | Baseline and week 52 | | | | ID | Title | Description |
|---|
| OG000 | Arm 1 - Formoterol | Formoterol 9 μg twice daily | | OG001 | Arm 2 - Standard Treatment | Standard COPD (JRS guideline and GOLD) treatment |
| |
| Primary | ECG Variables - QTcB Interval | | All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population. | Posted | | Mean | Standard Deviation | milisecond | | Baseline and week 52 | | | | ID | Title | Description |
|---|
| OG000 | Arm 1 - Formoterol | Formoterol 9 μg twice daily | | OG001 | Arm 2 - Standard Treatment | Standard COPD (JRS guideline and GOLD) treatment |
| |
| Primary | ECG Variables QTcF Interval | | All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population. | Posted | | Mean | Standard Deviation | milisecond | | Baseline and week 52 | | | | ID | Title | Description |
|---|
| OG000 | Arm 1 - Formoterol | Formoterol 9 μg twice daily | | OG001 | Arm 2 - Standard Treatment | Standard COPD (JRS guideline and GOLD) treatment |
| |
| Primary | ECG Variables RR Interval | | All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population. | Posted | | Mean | Standard Deviation | milisecond | | Baseline and week 52 | | | | ID | Title | Description |
|---|
| OG000 | Arm 1 - Formoterol | Formoterol 9 μg twice daily | | OG001 | Arm 2 - Standard Treatment | Standard COPD (JRS guideline and GOLD) treatment |
| |
| Secondary | Forced Expiratory Volume in One Second (FEV1) | The ratio of the average value of available data for mean from Weeks 0, 4, 8, 17, 26, 34, 43 and 52 to the baseline for each treatment group | All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS). | 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 - Formoterol | Formoterol 9 μg twice daily | | OG001 | Arm 2 - Standard Treatment | Standard COPD (JRS guideline and GOLD) treatment |
| |
| Secondary | Forced Vital Capacity (FVC) | 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 | All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS). | 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 - Formoterol | Formoterol 9 μg twice daily | | OG001 | Arm 2 - Standard Treatment | Standard COPD (JRS guideline and GOLD) treatment |
| |
| Secondary | Morning Peak Expiratory Flow(PEF) | The change from Run-in period average to Treatment period average for each treatment group | All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS). | Posted | | Mean | Standard Deviation | Liter/minute (L/min) | | Daily during run-in period (14 - 18 days before Randomisation visit)and daily during 52-week randomization treatment | | | | ID | Title | Description |
|---|
| OG000 | Arm 1 - Formoterol | Formoterol 9 μg twice daily | | OG001 | Arm 2 - Standard Treatment | Standard COPD (JRS guideline and GOLD) treatment |
| |
| Secondary | Evening Peak Expiratory Flow (PEF) | The change from Run-in period average to Treatment period average for each treatment group | All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS). | Posted | | Mean | Standard Deviation | Liter/minute (L/min) | | Daily during run-in period (14 - 18 days before Randomisation visit) and daily during 52-week randomization treatment | | | | ID | Title | Description |
|---|
| OG000 | Arm 1 - Formoterol | Formoterol 9 μg twice daily | | OG001 | Arm 2 - Standard Treatment | Standard COPD (JRS guideline and GOLD) treatment |
| |
| Secondary | Night-time Awakening Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms | There are 5 alternatives (scored 0 to 4, with 4 being the most severe condition). The change from Run-in period average to Treatment period average for each treatment group | All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS). | Posted | | Median | Standard Deviation | units on a scale | | Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment | | | | ID | Title | Description |
|---|
| OG000 | Arm 1 - Formoterol | Formoterol 9 μg twice daily | | OG001 | Arm 2 - Standard Treatment | Standard COPD (JRS guideline and GOLD) treatment |
| |
| Secondary | Daytime Breathlessness Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms | There are 5 alternatives (scored 0 to 4, with 4 being the most severe condition). The change from Run-in period average to Treatment period average for each treatment group | All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS). | Posted | | Mean | Standard Deviation | units on a scale | | Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment | | | | ID | Title | Description |
|---|
| OG000 | Arm 1 - Formoterol | Formoterol 9 μg twice daily | | OG001 | Arm 2 - Standard Treatment | Standard COPD (JRS guideline and GOLD) treatment |
| |
| Secondary | Daytime Cough Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms | There are 5 alternatives (scored 0 to 4, with 4 being the most severe condition). The change from Run-in period average to Treatment period average for each treatment group | All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS). | Posted | | Mean | Standard Deviation | units on a scale | | Daily during run-in period (14 - 18 days before Randomisation visit) and daily during 52-week randomization treatment | | | | ID | Title | Description |
|---|
| OG000 | Arm 1 - Formoterol | Formoterol 9 μg twice daily | | OG001 | Arm 2 - Standard Treatment | Standard COPD (JRS guideline and GOLD) treatment |
| |
| Secondary | Total Chronic Obstructive Pulmonary Disease (COPD) Symptom Score | The Total COPD Symptom score is the sum of the measures night-time awakening, breathlessness and cough, ranges from 0 to 12 with 12 being the most severe. The change from Run-in period average to Treatment period average for each treatment group. | All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS). | Posted | | Mean | Standard Deviation | units on a scale | | Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment | | | | ID | Title | Description |
|---|
| OG000 | Arm 1 - Formoterol | Formoterol 9 μg twice daily | | OG001 | Arm 2 - Standard Treatment | Standard COPD (JRS guideline and GOLD) treatment |
| |
| Secondary | Number of COPD Exacerbations Over the 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 was presented here. | All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS). | Posted | | Number | | number of exacerbations | | Daily during 52-week randomization treatment | | | | ID | Title | Description |
|---|
| OG000 | Arm 1 - Formoterol | Formoterol 9 μg twice daily | | OG001 | Arm 2 - Standard Treatment | Standard COPD (JRS guideline and GOLD) treatment |
| |
| Secondary | Use of SABA (Salbutamol) as Reliever Medication | The change from Run-in period average to Treatment period average for each treatment group. | All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS). | Posted | | Mean | Standard Deviation | Times/Day | | Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment | | | | ID | Title | Description |
|---|
| OG000 | Arm 1 - Formoterol | Formoterol 9 μg twice daily | | OG001 | Arm 2 - Standard Treatment | Standard COPD (JRS guideline and GOLD) treatment |
| |
| Secondary | St George's Respiratory Questionnaire (SGRQ) Total Score | SGRQ total score shows the impact of COPD on patient's health status, and expressed as a percentage of impairment with scale from 0 (best health status) to 100 (worst possible status). A negative rate of decline shows decreasing SGRQ total score (or improved health) over time, while a positive value shows increasing score (or worsen health). The change from Run-in period average to Treatment period average for each treatment group | All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS). | Posted | | Mean | Standard Deviation | units on a scale | | Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment | | | | ID | Title | Description |
|---|
| OG000 | Arm 1 - Formoterol | Formoterol 9 μg twice daily | | OG001 | Arm 2 - Standard Treatment | Standard COPD (JRS guideline and GOLD) treatment |
| |