Chronic Obstructive Pulmonary Disease
Conditions
Keywords
Symbicort, Safety, Efficacy, COPD, Japanese
Brief summary
The purpose of this study is to evaluate the safety and efficacy of Symbicort Turbuhaler compared to standard COPD treatment during one year in Japanese patients with COPD.
Interventions
DRUGSymbicort Turbuhaler (Budesonide/formoterol)
2 x 160/4.5 microgram, inhalation, bid, 52 weeks
DRUGDrug: any available COPD treatment; investigator to decide
According to investigator decision, 52 weeks, Standard COPD treatment according to investigator decision
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A current clinical diagnosis of COPD according to the guidelines (GOLD, JPS) * Documented COPD symptoms for more than 2 years * Pre-bronchodilator FEV1≦50% of predicted normal value, and post-bronchodilator FEV1/FVC\<70%
Exclusion criteria
* History and/or current clinical diagnosis of asthma and atopic diseases such as allergic rhinitis * Subjects with significant or unstable ischemic heart disease, arrhythmia, cardiomyopathy, heart failure, uncontrolled hypertension as defined by the investigator, or any other relevant cardiovascular disorder as judged by the investigator * COPD exacerbation during the run-in period or within 4 weeks prior to registration, requiring hospitalization and/or treatment with systemic steroids.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ECG Variables - RR Interval | Baseline and 52 week after | Change from baseline |
| Clinical Laboratory Test: Clinical Chemistry- S-Potassium | Baseline and 52 week after | Change from baseline |
| Clinical Laboratory Test: Clinical Chemistry- S- Calcium | Baseline and 52 week after | Change from baseline |
| Clinical Laboratory Test: Clinical Chemistry- S-Albumin | Baseline and 52 week after | Change from baseline |
| Clinical Laboratory Test: Clinical Chemistry- S-Protein, Total | Baseline and 52 week after | Change from baseline |
| Clinical Laboratory Test: Clinical Chemistry- S-C-Reactive Protein | Baseline and 52 week after | Change from baseline |
| Clinical Laboratory Test: Clinical Chemistry- S-Urea Nitrogen | Baseline and 52 week after | Change from baseline |
| Vital Signs- Sitting Systolic Blood Pressure(SBP) | Baseline and 52 week after | Change from baseline |
| Vital Signs- Sitting Diastolic Blood Pressure(DBP) | Baseline and 52 week after | Change from baseline |
| Vital Signs- Pulse Rate | Baseline and 52 week after | Change from baseline |
| ECG Variables - Heart Rate | Baseline and 52 week after | Change from baseline |
| ECG Variables - QT Interval | Baseline and 52 week after | Change from baseline |
| ECG Variables - QTcB Interval | Baseline and 52 week after | Change from baseline |
| ECG Variables - QTcF Interval | Baseline and 52 week after | Change from baseline |
| Clinical Laboratory Test: Haematology -Erythrocytes | Baseline and 52 week after | Mean change from Baseline |
| Clinical Laboratory Test: Haematology -Haemoglobin | Baseline and 52 week after | Change from baseline |
| Clinical Laboratory Test: Haematology -Leucocytes | Baseline and 52 week after | Change from baseline |
| Clinical Laboratory Test: Haematology -Platelet Count | Baseline and 52 week after | Change from baseline |
| Clinical Laboratory Test: Haematology -Eosinophils | Baseline and 52 week after | Change from baseline |
| Clinical Laboratory Test: Haematology -Basophils | Baseline and 52 week after | Change from baseline |
| Clinical Laboratory Test: Haematology -Lymphocytes | Baseline and 52 week after | Change from baseline |
| Clinical Laboratory Test: Haematology -Monocytes | Baseline and 52 week after | Change from baseline |
| Clinical Laboratory Test: Haematology -Neutrophils | Baseline and 52 week after | Change from baseline |
| Clinical Laboratory Test: Clinical Chemistry- S-Alanine Aminotransferase | Baseline and 52 week after | Change from baseline |
| Clinical Laboratory Test: Clinical Chemistry- S-Aspartate Aminotransferase | Baseline and 52 week after | Change from baseline |
| Clinical Laboratory Test: Clinical Chemistry- S-Alkaline Phosphatase (ALP) | Baseline and 52 week after | Change from baseline |
| Clinical Laboratory Test: Clinical Chemistry- S-Creatinine | Baseline and 52 week after | Change from baseline |
| Clinical Laboratory Test: Clinical Chemistry- S-Total Bilirubin | Baseline and 52 week after | Change from baseline |
| Clinical Laboratory Test: Clinical Chemistry- S-Sodium | Baseline and 52 week after | Change from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health Related Quality of Life (HRQL) Based on the St. George's Respiratory Questionnaire (SGRQ) | Daily during run-in period and daily 52-week randomization treatment | 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). |
| Morning Peak Expiratory Flow (PEF) Measured at Home | Daily during run-in period and daily 52-week randomization treatment | The change from Run-in period average to 52-week randomization Treatment period average for each treatment group |
| Chronic Obstructive Pulmonary Disease (COPD) symptoms_Night-time Awakening | Daily during run-in period and daily during 52-week randomization treatment | 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 |
| Chronic Obstructive Pulmonary Disease (COPD) symptoms_Breathlessness | Daily during run-in period and daily during 52-week randomization treatment | 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 |
| Chronic Obstructive Pulmonary Disease (COPD) symptoms_cough | Daily during run-in period and daily during 52-week randomization treatment | 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 |
| Forced Expiratory Volume in 1 Second (FEV1) Measured With the Spirometer at the Clinic | Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization | 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. |
| Forced Vital Capacity (FVC) Measured With the Spirometer at the Clinic | Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization | 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. |
| Time to First COPD Exacerbation | Daily during 52-week randomization treatment | 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. |
| Number of COPD Exacerbations Over the Study Treatment Period | Daily during 52-week randomization treatment | 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 |
| Rescue Medication Use | Daily during 52-week randomization treatment | The change from run-in period and daily during 52-week randomization treatment |
| Morning FEV1 Measured by the Subjects at Home | Daily during run-in period and daily 52-week randomization treatment | The change from run-in period and daily during 52-week randomization treatment |
| Evening FEV1 Measured by the Subjects at Home | Daily during run-in period and daily 52-week randomization treatment | The change from run-in period and daily during 52-week randomization treatment |
| Evening Peak Expiratory Flow (PEF) Measured at Home | Daily during run-in period and daily 52-week randomization treatment | The change from Run-in period average to 52-week randomization Treatment period average for each treatment group |
Countries
Japan
Participant flow
Recruitment details
The first participant entered the study on 28 January 2010, and the last participant completed the study on 24 October 2011. A total of 328 participants were enrolled at 60 centres in Japan, and 260 participants who fulfilled the randomisation criteria were randomised.
Pre-assignment details
The study starts with an enrolment visit, Visit 1 prior to any other study-related activity. At Visit 2, the lung function will be measured to assess the eligibility of the patients. Subjects who fulfil all eligibility criteria will begin the 2-week run-in period.During the period, the previous treatment will be continued to record the baseline.
Participants by arm
| Arm | Count |
|---|---|
| Symbicort Turbuhaler Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily | 130 |
| COPD Standard Therapy Standard COPD treatment according to JRS guideline and GOLD guideline | 130 |
| Total | 260 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 14 | 9 |
| Overall Study | Withdrawal by Subject | 6 | 9 |
Baseline characteristics
| Characteristic | Symbicort Turbuhaler | COPD Standard Therapy | Total |
|---|---|---|---|
| Age, Continuous | 70.1 Years | 71.5 Years | 70.8 Years |
| Sex: Female, Male Female | 5 Participants | 4 Participants | 9 Participants |
| Sex: Female, Male Male | 125 Participants | 126 Participants | 251 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 75 / 130 | 72 / 130 |
| serious Total, serious adverse events | 25 / 130 | 34 / 130 |
Outcome results
Primary
Clinical Laboratory Test: Clinical Chemistry- S-Alanine Aminotransferase
Change from baseline
Time frame: Baseline and 52 week after
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 - Symbicort Turbuhaler | Clinical Laboratory Test: Clinical Chemistry- S-Alanine Aminotransferase | 0.5 U/L | Standard Deviation 7.6 |
| Arm 2 - COPD Standard Therapy | Clinical Laboratory Test: Clinical Chemistry- S-Alanine Aminotransferase | 1.5 U/L | Standard Deviation 6.6 |
Primary
Clinical Laboratory Test: Clinical Chemistry- S-Albumin
Change from baseline
Time frame: Baseline and 52 week after
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 - Symbicort Turbuhaler | Clinical Laboratory Test: Clinical Chemistry- S-Albumin | 0.03 g/dL | Standard Deviation 0.24 |
| Arm 2 - COPD Standard Therapy | Clinical Laboratory Test: Clinical Chemistry- S-Albumin | 0.04 g/dL | Standard Deviation 0.26 |
Primary
Clinical Laboratory Test: Clinical Chemistry- S-Alkaline Phosphatase (ALP)
Change from baseline
Time frame: Baseline and 52 week after
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 - Symbicort Turbuhaler | Clinical Laboratory Test: Clinical Chemistry- S-Alkaline Phosphatase (ALP) | 1.3 U/L | Standard Deviation 38.4 |
| Arm 2 - COPD Standard Therapy | Clinical Laboratory Test: Clinical Chemistry- S-Alkaline Phosphatase (ALP) | 8.2 U/L | Standard Deviation 45.9 |
Primary
Clinical Laboratory Test: Clinical Chemistry- S-Aspartate Aminotransferase
Change from baseline
Time frame: Baseline and 52 week after
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 - Symbicort Turbuhaler | Clinical Laboratory Test: Clinical Chemistry- S-Aspartate Aminotransferase | 0.0 U/L | Standard Deviation 7.6 |
| Arm 2 - COPD Standard Therapy | Clinical Laboratory Test: Clinical Chemistry- S-Aspartate Aminotransferase | 1.1 U/L | Standard Deviation 6.5 |
Primary
Clinical Laboratory Test: Clinical Chemistry- S- Calcium
Change from baseline
Time frame: Baseline and 52 week after
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 - Symbicort Turbuhaler | Clinical Laboratory Test: Clinical Chemistry- S- Calcium | 0.02 mg/dL | Standard Deviation 0.34 |
| Arm 2 - COPD Standard Therapy | Clinical Laboratory Test: Clinical Chemistry- S- Calcium | 0.01 mg/dL | Standard Deviation 0.33 |
Primary
Clinical Laboratory Test: Clinical Chemistry- S-C-Reactive Protein
Change from baseline
Time frame: Baseline and 52 week after
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 - Symbicort Turbuhaler | Clinical Laboratory Test: Clinical Chemistry- S-C-Reactive Protein | 0.243 mg/dL | Standard Deviation 1.291 |
| Arm 2 - COPD Standard Therapy | Clinical Laboratory Test: Clinical Chemistry- S-C-Reactive Protein | 0.224 mg/dL | Standard Deviation 1.423 |
Primary
Clinical Laboratory Test: Clinical Chemistry- S-Creatinine
Change from baseline
Time frame: Baseline and 52 week after
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 - Symbicort Turbuhaler | Clinical Laboratory Test: Clinical Chemistry- S-Creatinine | 0.003 mg/dL | Standard Deviation 0.106 |
| Arm 2 - COPD Standard Therapy | Clinical Laboratory Test: Clinical Chemistry- S-Creatinine | -0.017 mg/dL | Standard Deviation 0.091 |
Primary
Clinical Laboratory Test: Clinical Chemistry- S-Potassium
Change from baseline
Time frame: Baseline and 52 week after
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 - Symbicort Turbuhaler | Clinical Laboratory Test: Clinical Chemistry- S-Potassium | -0.11 mEq/L | Standard Deviation 0.34 |
| Arm 2 - COPD Standard Therapy | Clinical Laboratory Test: Clinical Chemistry- S-Potassium | -0.08 mEq/L | Standard Deviation 0.37 |
Primary
Clinical Laboratory Test: Clinical Chemistry- S-Protein, Total
Change from baseline
Time frame: Baseline and 52 week after
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 - Symbicort Turbuhaler | Clinical Laboratory Test: Clinical Chemistry- S-Protein, Total | 0.01 g/dL | Standard Deviation 0.35 |
| Arm 2 - COPD Standard Therapy | Clinical Laboratory Test: Clinical Chemistry- S-Protein, Total | 0.02 g/dL | Standard Deviation 0.37 |
Primary
Clinical Laboratory Test: Clinical Chemistry- S-Sodium
Change from baseline
Time frame: Baseline and 52 week after
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 - Symbicort Turbuhaler | Clinical Laboratory Test: Clinical Chemistry- S-Sodium | -0.8 mEq/L | Standard Deviation 2 |
| Arm 2 - COPD Standard Therapy | Clinical Laboratory Test: Clinical Chemistry- S-Sodium | -0.6 mEq/L | Standard Deviation 1.7 |
Primary
Clinical Laboratory Test: Clinical Chemistry- S-Total Bilirubin
Change from baseline
Time frame: Baseline and 52 week after
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 - Symbicort Turbuhaler | Clinical Laboratory Test: Clinical Chemistry- S-Total Bilirubin | 0.05 mg/dL | Standard Deviation 0.25 |
| Arm 2 - COPD Standard Therapy | Clinical Laboratory Test: Clinical Chemistry- S-Total Bilirubin | 0.00 mg/dL | Standard Deviation 0.18 |
Primary
Clinical Laboratory Test: Clinical Chemistry- S-Urea Nitrogen
Change from baseline
Time frame: Baseline and 52 week after
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 - Symbicort Turbuhaler | Clinical Laboratory Test: Clinical Chemistry- S-Urea Nitrogen | -0.51 mg/dL | Standard Deviation 4.09 |
| Arm 2 - COPD Standard Therapy | Clinical Laboratory Test: Clinical Chemistry- S-Urea Nitrogen | -0.64 mg/dL | Standard Deviation 3.32 |
Primary
Clinical Laboratory Test: Haematology -Basophils
Change from baseline
Time frame: Baseline and 52 week after
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 - Symbicort Turbuhaler | Clinical Laboratory Test: Haematology -Basophils | -0.06 percentage of Basophils | Standard Deviation 0.37 |
| Arm 2 - COPD Standard Therapy | Clinical Laboratory Test: Haematology -Basophils | -0.06 percentage of Basophils | Standard Deviation 0.35 |
Primary
Clinical Laboratory Test: Haematology -Eosinophils
Change from baseline
Time frame: Baseline and 52 week after
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 - Symbicort Turbuhaler | Clinical Laboratory Test: Haematology -Eosinophils | -0.52 percentage of Eosinophils | Standard Deviation 2.68 |
| Arm 2 - COPD Standard Therapy | Clinical Laboratory Test: Haematology -Eosinophils | 0.14 percentage of Eosinophils | Standard Deviation 1.91 |
Primary
Clinical Laboratory Test: Haematology -Erythrocytes
Mean change from Baseline
Time frame: Baseline and 52 week after
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 - Symbicort Turbuhaler | Clinical Laboratory Test: Haematology -Erythrocytes | -7.6 *10000/μl | Standard Deviation 23.9 |
| Arm 2 - COPD Standard Therapy | Clinical Laboratory Test: Haematology -Erythrocytes | -0.1 *10000/μl | Standard Deviation 22.9 |
Primary
Clinical Laboratory Test: Haematology -Haemoglobin
Change from baseline
Time frame: Baseline and 52 week after
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 - Symbicort Turbuhaler | Clinical Laboratory Test: Haematology -Haemoglobin | -0.22 g/dL | Standard Deviation 0.74 |
| Arm 2 - COPD Standard Therapy | Clinical Laboratory Test: Haematology -Haemoglobin | -0.05 g/dL | Standard Deviation 0.75 |
Primary
Clinical Laboratory Test: Haematology -Leucocytes
Change from baseline
Time frame: Baseline and 52 week after
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 - Symbicort Turbuhaler | Clinical Laboratory Test: Haematology -Leucocytes | 160.8 /microliter(mcl) | Standard Deviation 1704 |
| Arm 2 - COPD Standard Therapy | Clinical Laboratory Test: Haematology -Leucocytes | -184.8 /microliter(mcl) | Standard Deviation 1238.2 |
Primary
Clinical Laboratory Test: Haematology -Lymphocytes
Change from baseline
Time frame: Baseline and 52 week after
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 - Symbicort Turbuhaler | Clinical Laboratory Test: Haematology -Lymphocytes | -5.47 percentage of Lymphocytes | Standard Deviation 6.56 |
| Arm 2 - COPD Standard Therapy | Clinical Laboratory Test: Haematology -Lymphocytes | -3.24 percentage of Lymphocytes | Standard Deviation 7 |
Primary
Clinical Laboratory Test: Haematology -Monocytes
Change from baseline
Time frame: Baseline and 52 week after
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 - Symbicort Turbuhaler | Clinical Laboratory Test: Haematology -Monocytes | 0.29 percentage of Monocytes | Standard Deviation 1.41 |
| Arm 2 - COPD Standard Therapy | Clinical Laboratory Test: Haematology -Monocytes | -0.03 percentage of Monocytes | Standard Deviation 1.35 |
Primary
Clinical Laboratory Test: Haematology -Neutrophils
Change from baseline
Time frame: Baseline and 52 week after
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 - Symbicort Turbuhaler | Clinical Laboratory Test: Haematology -Neutrophils | 5.78 percentage of Neutrophils | Standard Deviation 7.16 |
| Arm 2 - COPD Standard Therapy | Clinical Laboratory Test: Haematology -Neutrophils | 2.92 percentage of Neutrophils | Standard Deviation 7.64 |
Primary
Clinical Laboratory Test: Haematology -Platelet Count
Change from baseline
Time frame: Baseline and 52 week after
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 - Symbicort Turbuhaler | Clinical Laboratory Test: Haematology -Platelet Count | 0.86 *10000/μl | Standard Deviation 3.03 |
| Arm 2 - COPD Standard Therapy | Clinical Laboratory Test: Haematology -Platelet Count | 0.12 *10000/μl | Standard Deviation 4.04 |
Primary
ECG Variables - Heart Rate
Change from baseline
Time frame: Baseline and 52 week after
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 - Symbicort Turbuhaler | ECG Variables - Heart Rate | 3.6 beats/minute | Standard Deviation 11.4 |
| Arm 2 - COPD Standard Therapy | ECG Variables - Heart Rate | 3.4 beats/minute | Standard Deviation 10.9 |
Primary
ECG Variables - QTcB Interval
Change from baseline
Time frame: Baseline and 52 week after
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 - Symbicort Turbuhaler | ECG Variables - QTcB Interval | 3.6 ms | Standard Deviation 20.9 |
| Arm 2 - COPD Standard Therapy | ECG Variables - QTcB Interval | 2.4 ms | Standard Deviation 22.6 |
Primary
ECG Variables - QTcF Interval
Change from baseline
Time frame: Baseline and 52 week after
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 - Symbicort Turbuhaler | ECG Variables - QTcF Interval | 0.7 ms | Standard Deviation 16.3 |
| Arm 2 - COPD Standard Therapy | ECG Variables - QTcF Interval | -1.1 ms | Standard Deviation 17.4 |
Primary
ECG Variables - QT Interval
Change from baseline
Time frame: Baseline and 52 week after
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 - Symbicort Turbuhaler | ECG Variables - QT Interval | -4.5 ms | Standard Deviation 23.1 |
| Arm 2 - COPD Standard Therapy | ECG Variables - QT Interval | -7.5 ms | Standard Deviation 21.2 |
Primary
ECG Variables - RR Interval
Change from baseline
Time frame: Baseline and 52 week after
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 - Symbicort Turbuhaler | ECG Variables - RR Interval | -30.9 ms | Standard Deviation 121.4 |
| Arm 2 - COPD Standard Therapy | ECG Variables - RR Interval | -43.8 ms | Standard Deviation 115.1 |
Primary
Vital Signs- Pulse Rate
Change from baseline
Time frame: Baseline and 52 week after
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 - Symbicort Turbuhaler | Vital Signs- Pulse Rate | 3.2 beats/minute | Standard Deviation 11.1 |
| Arm 2 - COPD Standard Therapy | Vital Signs- Pulse Rate | 3.1 beats/minute | Standard Deviation 11.5 |
Primary
Vital Signs- Sitting Diastolic Blood Pressure(DBP)
Change from baseline
Time frame: Baseline and 52 week after
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 - Symbicort Turbuhaler | Vital Signs- Sitting Diastolic Blood Pressure(DBP) | -0.8 mmHg | Standard Deviation 11.2 |
| Arm 2 - COPD Standard Therapy | Vital Signs- Sitting Diastolic Blood Pressure(DBP) | -1.3 mmHg | Standard Deviation 10.7 |
Primary
Vital Signs- Sitting Systolic Blood Pressure(SBP)
Change from baseline
Time frame: Baseline and 52 week after
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 - Symbicort Turbuhaler | Vital Signs- Sitting Systolic Blood Pressure(SBP) | -0.8 mmHg | Standard Deviation 16.2 |
| Arm 2 - COPD Standard Therapy | Vital Signs- Sitting Systolic Blood Pressure(SBP) | -3.2 mmHg | Standard Deviation 15 |
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
Time frame: Daily during run-in period and daily during 52-week randomization treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 - Symbicort Turbuhaler | Chronic Obstructive Pulmonary Disease (COPD) symptoms_Breathlessness | -0.2 units on a scale | Standard Deviation 0.7 |
| Arm 2 - COPD Standard Therapy | Chronic Obstructive Pulmonary Disease (COPD) symptoms_Breathlessness | -0.1 units on a scale | Standard Deviation 0.7 |
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
Time frame: Daily during run-in period and daily during 52-week randomization treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 - Symbicort Turbuhaler | Chronic Obstructive Pulmonary Disease (COPD) symptoms_cough | -0.2 units on a scale | Standard Deviation 0.7 |
| Arm 2 - COPD Standard Therapy | Chronic Obstructive Pulmonary Disease (COPD) symptoms_cough | -0.2 units on a scale | Standard Deviation 0.7 |
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
Time frame: Daily during run-in period and daily during 52-week randomization treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 - Symbicort Turbuhaler | Chronic Obstructive Pulmonary Disease (COPD) symptoms_Night-time Awakening | 0.0 units on a scale | Standard Deviation 0.5 |
| Arm 2 - COPD Standard Therapy | Chronic Obstructive Pulmonary Disease (COPD) symptoms_Night-time Awakening | -0.1 units on a scale | Standard Deviation 0.4 |
Secondary
Evening FEV1 Measured by the Subjects at Home
The change from run-in period and daily during 52-week randomization treatment
Time frame: Daily during run-in period and daily 52-week randomization treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 - Symbicort Turbuhaler | Evening FEV1 Measured by the Subjects at Home | 0.006 Liter(L) | Standard Deviation 0.142 |
| Arm 2 - COPD Standard Therapy | Evening FEV1 Measured by the Subjects at Home | 0.010 Liter(L) | Standard Deviation 0.156 |
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
Time frame: Daily during run-in period and daily 52-week randomization treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 - Symbicort Turbuhaler | Evening Peak Expiratory Flow (PEF) Measured at Home | 2.7 Liter/minute(L/min) | Standard Deviation 30 |
| Arm 2 - COPD Standard Therapy | Evening Peak Expiratory Flow (PEF) Measured at Home | 5.2 Liter/minute(L/min) | Standard Deviation 29.3 |
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.
Time frame: Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Arm 1 - Symbicort Turbuhaler | Forced Expiratory Volume in 1 Second (FEV1) Measured With the Spirometer at the Clinic | 104.25 percentage of Baseline |
| Arm 2 - COPD Standard Therapy | Forced Expiratory Volume in 1 Second (FEV1) Measured With the Spirometer at the Clinic | 98.43 percentage of Baseline |
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.
Time frame: Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Arm 1 - Symbicort Turbuhaler | Forced Vital Capacity (FVC) Measured With the Spirometer at the Clinic | 102.51 percentage of Baseline |
| Arm 2 - COPD Standard Therapy | Forced Vital Capacity (FVC) Measured With the Spirometer at the Clinic | 100.04 percentage of Baseline |
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).
Time frame: Daily during run-in period and daily 52-week randomization treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 - Symbicort Turbuhaler | Health Related Quality of Life (HRQL) Based on the St. George's Respiratory Questionnaire (SGRQ) | -2.03 units on a scale | Standard Deviation 8.56 |
| Arm 2 - COPD Standard Therapy | Health Related Quality of Life (HRQL) Based on the St. George's Respiratory Questionnaire (SGRQ) | -0.42 units on a scale | Standard Deviation 7.47 |
Secondary
Morning FEV1 Measured by the Subjects at Home
The change from run-in period and daily during 52-week randomization treatment
Time frame: Daily during run-in period and daily 52-week randomization treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 - Symbicort Turbuhaler | Morning FEV1 Measured by the Subjects at Home | 0.017 Liter(L) | Standard Deviation 0.147 |
| Arm 2 - COPD Standard Therapy | Morning FEV1 Measured by the Subjects at Home | 0.006 Liter(L) | Standard Deviation 0.171 |
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
Time frame: Daily during run-in period and daily 52-week randomization treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 - Symbicort Turbuhaler | Morning Peak Expiratory Flow (PEF) Measured at Home | 5.9 Liter/minute(L/min) | Standard Deviation 31.8 |
| Arm 2 - COPD Standard Therapy | Morning Peak Expiratory Flow (PEF) Measured at Home | 5.7 Liter/minute(L/min) | Standard Deviation 30.9 |
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
Time frame: Daily during 52-week randomization treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1 - Symbicort Turbuhaler | Number of COPD Exacerbations Over the Study Treatment Period | 41 event |
| Arm 2 - COPD Standard Therapy | Number of COPD Exacerbations Over the Study Treatment Period | 105 event |
Secondary
Rescue Medication Use
The change from run-in period and daily during 52-week randomization treatment
Time frame: Daily during 52-week randomization treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 - Symbicort Turbuhaler | Rescue Medication Use | -0.2 innhalation/day | Standard Deviation 1 |
| Arm 2 - COPD Standard Therapy | Rescue Medication Use | 0.0 innhalation/day | Standard Deviation 1.4 |
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.
Time frame: Daily during 52-week randomization treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1 - Symbicort Turbuhaler | Time to First COPD Exacerbation | 20.0 Percentage of participants |
| Arm 2 - COPD Standard Therapy | Time to First COPD Exacerbation | 31.5 Percentage of participants |