Trial Outcomes & Findings for A Safety and Efficacy Study of Symbicort Turbuhaler Compared With Standard Chronic Obstructive Pulmonary Disease (COPD) Treatment in Japan (NCT NCT01070784)
NCT ID: NCT01070784
Last Updated: 2014-04-29
Results Overview
Mean change from Baseline
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
328 participants
Primary outcome timeframe
Baseline and 52 week after
Results posted on
2014-04-29
Participant Flow
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.
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.
Participant milestones
| Measure |
Symbicort Turbuhaler
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
|
COPD Standard Therapy
Standard COPD treatment according to JRS guideline and GOLD guideline
|
|---|---|---|
|
Overall Study
STARTED
|
130
|
130
|
|
Overall Study
COMPLETED
|
110
|
112
|
|
Overall Study
NOT COMPLETED
|
20
|
18
|
Reasons for withdrawal
| Measure |
Symbicort Turbuhaler
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
|
COPD Standard Therapy
Standard COPD treatment according to JRS guideline and GOLD guideline
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
9
|
|
Overall Study
Adverse Event
|
14
|
9
|
Baseline Characteristics
A Safety and Efficacy Study of Symbicort Turbuhaler Compared With Standard Chronic Obstructive Pulmonary Disease (COPD) Treatment in Japan
Baseline characteristics by cohort
| Measure |
Symbicort Turbuhaler
n=130 Participants
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
|
COPD Standard Therapy
n=130 Participants
Standard COPD treatment according to JRS guideline and GOLD guideline
|
Total
n=260 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.1 Years
n=5 Participants
|
71.5 Years
n=7 Participants
|
70.8 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
125 Participants
n=5 Participants
|
126 Participants
n=7 Participants
|
251 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 52 week afterMean change from Baseline
Outcome measures
| Measure |
Arm 1 - Symbicort Turbuhaler
n=124 Participants
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
|
Arm 2 - COPD Standard Therapy
n=120 Participants
Standard COPD treatment according to JRS guideline and GOLD guideline
|
|---|---|---|
|
Clinical Laboratory Test: Haematology -Erythrocytes
|
-7.6 *10000/μl
Standard Deviation 23.9
|
-0.1 *10000/μl
Standard Deviation 22.9
|
PRIMARY outcome
Timeframe: Baseline and 52 week afterChange from baseline
Outcome measures
| Measure |
Arm 1 - Symbicort Turbuhaler
n=124 Participants
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
|
Arm 2 - COPD Standard Therapy
n=120 Participants
Standard COPD treatment according to JRS guideline and GOLD guideline
|
|---|---|---|
|
Clinical Laboratory Test: Haematology -Haemoglobin
|
-0.22 g/dL
Standard Deviation 0.74
|
-0.05 g/dL
Standard Deviation 0.75
|
PRIMARY outcome
Timeframe: Baseline and 52 week afterChange from baseline
Outcome measures
| Measure |
Arm 1 - Symbicort Turbuhaler
n=123 Participants
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
|
Arm 2 - COPD Standard Therapy
n=120 Participants
Standard COPD treatment according to JRS guideline and GOLD guideline
|
|---|---|---|
|
Clinical Laboratory Test: Haematology -Leucocytes
|
160.8 /microliter(mcl)
Standard Deviation 1704.0
|
-184.8 /microliter(mcl)
Standard Deviation 1238.2
|
PRIMARY outcome
Timeframe: Baseline and 52 week afterChange from baseline
Outcome measures
| Measure |
Arm 1 - Symbicort Turbuhaler
n=120 Participants
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
|
Arm 2 - COPD Standard Therapy
n=117 Participants
Standard COPD treatment according to JRS guideline and GOLD guideline
|
|---|---|---|
|
Clinical Laboratory Test: Haematology -Platelet Count
|
0.86 *10000/μl
Standard Deviation 3.03
|
0.12 *10000/μl
Standard Deviation 4.04
|
PRIMARY outcome
Timeframe: Baseline and 52 week afterChange from baseline
Outcome measures
| Measure |
Arm 1 - Symbicort Turbuhaler
n=123 Participants
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
|
Arm 2 - COPD Standard Therapy
n=120 Participants
Standard COPD treatment according to JRS guideline and GOLD guideline
|
|---|---|---|
|
Clinical Laboratory Test: Haematology -Eosinophils
|
-0.52 percentage of Eosinophils
Standard Deviation 2.68
|
0.14 percentage of Eosinophils
Standard Deviation 1.91
|
PRIMARY outcome
Timeframe: Baseline and 52 week afterChange from baseline
Outcome measures
| Measure |
Arm 1 - Symbicort Turbuhaler
n=123 Participants
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
|
Arm 2 - COPD Standard Therapy
n=120 Participants
Standard COPD treatment according to JRS guideline and GOLD guideline
|
|---|---|---|
|
Clinical Laboratory Test: Haematology -Basophils
|
-0.06 percentage of Basophils
Standard Deviation 0.37
|
-0.06 percentage of Basophils
Standard Deviation 0.35
|
PRIMARY outcome
Timeframe: Baseline and 52 week afterChange from baseline
Outcome measures
| Measure |
Arm 1 - Symbicort Turbuhaler
n=123 Participants
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
|
Arm 2 - COPD Standard Therapy
n=120 Participants
Standard COPD treatment according to JRS guideline and GOLD guideline
|
|---|---|---|
|
Clinical Laboratory Test: Haematology -Lymphocytes
|
-5.47 percentage of Lymphocytes
Standard Deviation 6.56
|
-3.24 percentage of Lymphocytes
Standard Deviation 7.00
|
PRIMARY outcome
Timeframe: Baseline and 52 week afterChange from baseline
Outcome measures
| Measure |
Arm 1 - Symbicort Turbuhaler
n=123 Participants
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
|
Arm 2 - COPD Standard Therapy
n=120 Participants
Standard COPD treatment according to JRS guideline and GOLD guideline
|
|---|---|---|
|
Clinical Laboratory Test: Haematology -Monocytes
|
0.29 percentage of Monocytes
Standard Deviation 1.41
|
-0.03 percentage of Monocytes
Standard Deviation 1.35
|
PRIMARY outcome
Timeframe: Baseline and 52 week afterChange from baseline
Outcome measures
| Measure |
Arm 1 - Symbicort Turbuhaler
n=111 Participants
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
|
Arm 2 - COPD Standard Therapy
n=97 Participants
Standard COPD treatment according to JRS guideline and GOLD guideline
|
|---|---|---|
|
Clinical Laboratory Test: Haematology -Neutrophils
|
5.78 percentage of Neutrophils
Standard Deviation 7.16
|
2.92 percentage of Neutrophils
Standard Deviation 7.64
|
PRIMARY outcome
Timeframe: Baseline and 52 week afterChange from baseline
Outcome measures
| Measure |
Arm 1 - Symbicort Turbuhaler
n=124 Participants
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
|
Arm 2 - COPD Standard Therapy
n=119 Participants
Standard COPD treatment according to JRS guideline and GOLD guideline
|
|---|---|---|
|
Clinical Laboratory Test: Clinical Chemistry- S-Alanine Aminotransferase
|
0.5 U/L
Standard Deviation 7.6
|
1.5 U/L
Standard Deviation 6.6
|
PRIMARY outcome
Timeframe: Baseline and 52 week afterChange from baseline
Outcome measures
| Measure |
Arm 1 - Symbicort Turbuhaler
n=124 Participants
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
|
Arm 2 - COPD Standard Therapy
n=119 Participants
Standard COPD treatment according to JRS guideline and GOLD guideline
|
|---|---|---|
|
Clinical Laboratory Test: Clinical Chemistry- S-Aspartate Aminotransferase
|
0.0 U/L
Standard Deviation 7.6
|
1.1 U/L
Standard Deviation 6.5
|
PRIMARY outcome
Timeframe: Baseline and 52 week afterChange from baseline
Outcome measures
| Measure |
Arm 1 - Symbicort Turbuhaler
n=124 Participants
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
|
Arm 2 - COPD Standard Therapy
n=119 Participants
Standard COPD treatment according to JRS guideline and GOLD guideline
|
|---|---|---|
|
Clinical Laboratory Test: Clinical Chemistry- S-Alkaline Phosphatase (ALP)
|
1.3 U/L
Standard Deviation 38.4
|
8.2 U/L
Standard Deviation 45.9
|
PRIMARY outcome
Timeframe: Baseline and 52 week afterChange from baseline
Outcome measures
| Measure |
Arm 1 - Symbicort Turbuhaler
n=124 Participants
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
|
Arm 2 - COPD Standard Therapy
n=119 Participants
Standard COPD treatment according to JRS guideline and GOLD guideline
|
|---|---|---|
|
Clinical Laboratory Test: Clinical Chemistry- S-Creatinine
|
0.003 mg/dL
Standard Deviation 0.106
|
-0.017 mg/dL
Standard Deviation 0.091
|
PRIMARY outcome
Timeframe: Baseline and 52 week afterChange from baseline
Outcome measures
| Measure |
Arm 1 - Symbicort Turbuhaler
n=124 Participants
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
|
Arm 2 - COPD Standard Therapy
n=119 Participants
Standard COPD treatment according to JRS guideline and GOLD guideline
|
|---|---|---|
|
Clinical Laboratory Test: Clinical Chemistry- S-Total Bilirubin
|
0.05 mg/dL
Standard Deviation 0.25
|
0.00 mg/dL
Standard Deviation 0.18
|
PRIMARY outcome
Timeframe: Baseline and 52 week afterChange from baseline
Outcome measures
| Measure |
Arm 1 - Symbicort Turbuhaler
n=124 Participants
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
|
Arm 2 - COPD Standard Therapy
n=119 Participants
Standard COPD treatment according to JRS guideline and GOLD guideline
|
|---|---|---|
|
Clinical Laboratory Test: Clinical Chemistry- S-Sodium
|
-0.8 mEq/L
Standard Deviation 2.0
|
-0.6 mEq/L
Standard Deviation 1.7
|
PRIMARY outcome
Timeframe: Baseline and 52 week afterChange from baseline
Outcome measures
| Measure |
Arm 1 - Symbicort Turbuhaler
n=124 Participants
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
|
Arm 2 - COPD Standard Therapy
n=119 Participants
Standard COPD treatment according to JRS guideline and GOLD guideline
|
|---|---|---|
|
Clinical Laboratory Test: Clinical Chemistry- S-Potassium
|
-0.11 mEq/L
Standard Deviation 0.34
|
-0.08 mEq/L
Standard Deviation 0.37
|
PRIMARY outcome
Timeframe: Baseline and 52 week afterChange from baseline
Outcome measures
| Measure |
Arm 1 - Symbicort Turbuhaler
n=124 Participants
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
|
Arm 2 - COPD Standard Therapy
n=119 Participants
Standard COPD treatment according to JRS guideline and GOLD guideline
|
|---|---|---|
|
Clinical Laboratory Test: Clinical Chemistry- S- Calcium
|
0.02 mg/dL
Standard Deviation 0.34
|
0.01 mg/dL
Standard Deviation 0.33
|
PRIMARY outcome
Timeframe: Baseline and 52 week afterChange from baseline
Outcome measures
| Measure |
Arm 1 - Symbicort Turbuhaler
n=124 Participants
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
|
Arm 2 - COPD Standard Therapy
n=119 Participants
Standard COPD treatment according to JRS guideline and GOLD guideline
|
|---|---|---|
|
Clinical Laboratory Test: Clinical Chemistry- S-Albumin
|
0.03 g/dL
Standard Deviation 0.24
|
0.04 g/dL
Standard Deviation 0.26
|
PRIMARY outcome
Timeframe: Baseline and 52 week afterChange from baseline
Outcome measures
| Measure |
Arm 1 - Symbicort Turbuhaler
n=124 Participants
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
|
Arm 2 - COPD Standard Therapy
n=119 Participants
Standard COPD treatment according to JRS guideline and GOLD guideline
|
|---|---|---|
|
Clinical Laboratory Test: Clinical Chemistry- S-Protein, Total
|
0.01 g/dL
Standard Deviation 0.35
|
0.02 g/dL
Standard Deviation 0.37
|
PRIMARY outcome
Timeframe: Baseline and 52 week afterChange from baseline
Outcome measures
| Measure |
Arm 1 - Symbicort Turbuhaler
n=124 Participants
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
|
Arm 2 - COPD Standard Therapy
n=119 Participants
Standard COPD treatment according to JRS guideline and GOLD guideline
|
|---|---|---|
|
Clinical Laboratory Test: Clinical Chemistry- S-C-Reactive Protein
|
0.243 mg/dL
Standard Deviation 1.291
|
0.224 mg/dL
Standard Deviation 1.423
|
PRIMARY outcome
Timeframe: Baseline and 52 week afterChange from baseline
Outcome measures
| Measure |
Arm 1 - Symbicort Turbuhaler
n=124 Participants
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
|
Arm 2 - COPD Standard Therapy
n=119 Participants
Standard COPD treatment according to JRS guideline and GOLD guideline
|
|---|---|---|
|
Clinical Laboratory Test: Clinical Chemistry- S-Urea Nitrogen
|
-0.51 mg/dL
Standard Deviation 4.09
|
-0.64 mg/dL
Standard Deviation 3.32
|
PRIMARY outcome
Timeframe: Baseline and 52 week afterChange from baseline
Outcome measures
| Measure |
Arm 1 - Symbicort Turbuhaler
n=126 Participants
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
|
Arm 2 - COPD Standard Therapy
n=125 Participants
Standard COPD treatment according to JRS guideline and GOLD guideline
|
|---|---|---|
|
Vital Signs- Sitting Systolic Blood Pressure(SBP)
|
-0.8 mmHg
Standard Deviation 16.2
|
-3.2 mmHg
Standard Deviation 15.0
|
PRIMARY outcome
Timeframe: Baseline and 52 week afterChange from baseline
Outcome measures
| Measure |
Arm 1 - Symbicort Turbuhaler
n=126 Participants
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
|
Arm 2 - COPD Standard Therapy
n=125 Participants
Standard COPD treatment according to JRS guideline and GOLD guideline
|
|---|---|---|
|
Vital Signs- Sitting Diastolic Blood Pressure(DBP)
|
-0.8 mmHg
Standard Deviation 11.2
|
-1.3 mmHg
Standard Deviation 10.7
|
PRIMARY outcome
Timeframe: Baseline and 52 week afterChange from baseline
Outcome measures
| Measure |
Arm 1 - Symbicort Turbuhaler
n=126 Participants
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
|
Arm 2 - COPD Standard Therapy
n=125 Participants
Standard COPD treatment according to JRS guideline and GOLD guideline
|
|---|---|---|
|
Vital Signs- Pulse Rate
|
3.2 beats/minute
Standard Deviation 11.1
|
3.1 beats/minute
Standard Deviation 11.5
|
PRIMARY outcome
Timeframe: Baseline and 52 week afterChange from baseline
Outcome measures
| Measure |
Arm 1 - Symbicort Turbuhaler
n=125 Participants
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
|
Arm 2 - COPD Standard Therapy
n=121 Participants
Standard COPD treatment according to JRS guideline and GOLD guideline
|
|---|---|---|
|
ECG Variables - Heart Rate
|
3.6 beats/minute
Standard Deviation 11.4
|
3.4 beats/minute
Standard Deviation 10.9
|
PRIMARY outcome
Timeframe: Baseline and 52 week afterChange from baseline
Outcome measures
| Measure |
Arm 1 - Symbicort Turbuhaler
n=125 Participants
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
|
Arm 2 - COPD Standard Therapy
n=121 Participants
Standard COPD treatment according to JRS guideline and GOLD guideline
|
|---|---|---|
|
ECG Variables - QT Interval
|
-4.5 ms
Standard Deviation 23.1
|
-7.5 ms
Standard Deviation 21.2
|
PRIMARY outcome
Timeframe: Baseline and 52 week afterChange from baseline
Outcome measures
| Measure |
Arm 1 - Symbicort Turbuhaler
n=125 Participants
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
|
Arm 2 - COPD Standard Therapy
n=121 Participants
Standard COPD treatment according to JRS guideline and GOLD guideline
|
|---|---|---|
|
ECG Variables - QTcB Interval
|
3.6 ms
Standard Deviation 20.9
|
2.4 ms
Standard Deviation 22.6
|
PRIMARY outcome
Timeframe: Baseline and 52 week afterChange from baseline
Outcome measures
| Measure |
Arm 1 - Symbicort Turbuhaler
n=125 Participants
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
|
Arm 2 - COPD Standard Therapy
n=121 Participants
Standard COPD treatment according to JRS guideline and GOLD guideline
|
|---|---|---|
|
ECG Variables - QTcF Interval
|
0.7 ms
Standard Deviation 16.3
|
-1.1 ms
Standard Deviation 17.4
|
PRIMARY outcome
Timeframe: Baseline and 52 week afterChange from baseline
Outcome measures
| Measure |
Arm 1 - Symbicort Turbuhaler
n=125 Participants
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
|
Arm 2 - COPD Standard Therapy
n=121 Participants
Standard COPD treatment according to JRS guideline and GOLD guideline
|
|---|---|---|
|
ECG Variables - RR Interval
|
-30.9 ms
Standard Deviation 121.4
|
-43.8 ms
Standard Deviation 115.1
|
SECONDARY outcome
Timeframe: Daily during run-in period and daily during 52-week randomization treatmentThere 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
Outcome measures
| Measure |
Arm 1 - Symbicort Turbuhaler
n=130 Participants
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
|
Arm 2 - COPD Standard Therapy
n=130 Participants
Standard COPD treatment according to JRS guideline and GOLD guideline
|
|---|---|---|
|
Chronic Obstructive Pulmonary Disease (COPD) symptoms_Night-time Awakening
|
0.0 units on a scale
Standard Deviation 0.5
|
-0.1 units on a scale
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Daily during run-in period and daily during 52-week randomization treatmentThere 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
Outcome measures
| Measure |
Arm 1 - Symbicort Turbuhaler
n=130 Participants
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
|
Arm 2 - COPD Standard Therapy
n=130 Participants
Standard COPD treatment according to JRS guideline and GOLD guideline
|
|---|---|---|
|
Chronic Obstructive Pulmonary Disease (COPD) symptoms_Breathlessness
|
-0.2 units on a scale
Standard Deviation 0.7
|
-0.1 units on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Daily during run-in period and daily during 52-week randomization treatmentThere 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
Outcome measures
| Measure |
Arm 1 - Symbicort Turbuhaler
n=130 Participants
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
|
Arm 2 - COPD Standard Therapy
n=130 Participants
Standard COPD treatment according to JRS guideline and GOLD guideline
|
|---|---|---|
|
Chronic Obstructive Pulmonary Disease (COPD) symptoms_cough
|
-0.2 units on a scale
Standard Deviation 0.7
|
-0.2 units on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomizationThe 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.
Outcome measures
| Measure |
Arm 1 - Symbicort Turbuhaler
n=129 Participants
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
|
Arm 2 - COPD Standard Therapy
n=129 Participants
Standard COPD treatment according to JRS guideline and GOLD guideline
|
|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1) Measured With the Spirometer at the Clinic
|
104.25 percentage of Baseline
Interval 60.8 to 182.9
|
98.43 percentage of Baseline
Interval 35.8 to 168.2
|
SECONDARY outcome
Timeframe: Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomizationThe 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.
Outcome measures
| Measure |
Arm 1 - Symbicort Turbuhaler
n=129 Participants
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
|
Arm 2 - COPD Standard Therapy
n=129 Participants
Standard COPD treatment according to JRS guideline and GOLD guideline
|
|---|---|---|
|
Forced Vital Capacity (FVC) Measured With the Spirometer at the Clinic
|
102.51 percentage of Baseline
Interval 77.8 to 141.5
|
100.04 percentage of Baseline
Interval 67.6 to 158.2
|
SECONDARY outcome
Timeframe: Daily during 52-week randomization treatmentA 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.
Outcome measures
| Measure |
Arm 1 - Symbicort Turbuhaler
n=130 Participants
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
|
Arm 2 - COPD Standard Therapy
n=130 Participants
Standard COPD treatment according to JRS guideline and GOLD guideline
|
|---|---|---|
|
Time to First COPD Exacerbation
|
20.0 Percentage of participants
|
31.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Daily during 52-week randomization treatmentA 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
Outcome measures
| Measure |
Arm 1 - Symbicort Turbuhaler
n=130 Participants
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
|
Arm 2 - COPD Standard Therapy
n=130 Participants
Standard COPD treatment according to JRS guideline and GOLD guideline
|
|---|---|---|
|
Number of COPD Exacerbations Over the Study Treatment Period
|
41 event
|
105 event
|
SECONDARY outcome
Timeframe: Daily during 52-week randomization treatmentThe change from run-in period and daily during 52-week randomization treatment
Outcome measures
| Measure |
Arm 1 - Symbicort Turbuhaler
n=130 Participants
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
|
Arm 2 - COPD Standard Therapy
n=130 Participants
Standard COPD treatment according to JRS guideline and GOLD guideline
|
|---|---|---|
|
Rescue Medication Use
|
-0.2 innhalation/day
Standard Deviation 1.0
|
0.0 innhalation/day
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Daily during run-in period and daily 52-week randomization treatmentThe 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).
Outcome measures
| Measure |
Arm 1 - Symbicort Turbuhaler
n=130 Participants
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
|
Arm 2 - COPD Standard Therapy
n=130 Participants
Standard COPD treatment according to JRS guideline and GOLD guideline
|
|---|---|---|
|
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
|
-0.42 units on a scale
Standard Deviation 7.47
|
SECONDARY outcome
Timeframe: Daily during run-in period and daily 52-week randomization treatmentThe change from Run-in period average to 52-week randomization Treatment period average for each treatment group
Outcome measures
| Measure |
Arm 1 - Symbicort Turbuhaler
n=126 Participants
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
|
Arm 2 - COPD Standard Therapy
n=123 Participants
Standard COPD treatment according to JRS guideline and GOLD guideline
|
|---|---|---|
|
Morning Peak Expiratory Flow (PEF) Measured at Home
|
5.9 Liter/minute(L/min)
Standard Deviation 31.8
|
5.7 Liter/minute(L/min)
Standard Deviation 30.9
|
SECONDARY outcome
Timeframe: Daily during run-in period and daily 52-week randomization treatmentThe change from Run-in period average to 52-week randomization Treatment period average for each treatment group
Outcome measures
| Measure |
Arm 1 - Symbicort Turbuhaler
n=125 Participants
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
|
Arm 2 - COPD Standard Therapy
n=122 Participants
Standard COPD treatment according to JRS guideline and GOLD guideline
|
|---|---|---|
|
Evening Peak Expiratory Flow (PEF) Measured at Home
|
2.7 Liter/minute(L/min)
Standard Deviation 30.0
|
5.2 Liter/minute(L/min)
Standard Deviation 29.3
|
SECONDARY outcome
Timeframe: Daily during run-in period and daily 52-week randomization treatmentThe change from run-in period and daily during 52-week randomization treatment
Outcome measures
| Measure |
Arm 1 - Symbicort Turbuhaler
n=126 Participants
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
|
Arm 2 - COPD Standard Therapy
n=123 Participants
Standard COPD treatment according to JRS guideline and GOLD guideline
|
|---|---|---|
|
Morning FEV1 Measured by the Subjects at Home
|
0.017 Liter(L)
Standard Deviation 0.147
|
0.006 Liter(L)
Standard Deviation 0.171
|
SECONDARY outcome
Timeframe: Daily during run-in period and daily 52-week randomization treatmentThe change from run-in period and daily during 52-week randomization treatment
Outcome measures
| Measure |
Arm 1 - Symbicort Turbuhaler
n=125 Participants
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
|
Arm 2 - COPD Standard Therapy
n=122 Participants
Standard COPD treatment according to JRS guideline and GOLD guideline
|
|---|---|---|
|
Evening FEV1 Measured by the Subjects at Home
|
0.006 Liter(L)
Standard Deviation 0.142
|
0.010 Liter(L)
Standard Deviation 0.156
|
Adverse Events
Symbicort Turbuhaler
Serious events: 25 serious events
Other events: 75 other events
Deaths: 0 deaths
COPD Standard Therapy
Serious events: 34 serious events
Other events: 72 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Symbicort Turbuhaler
n=130 participants at risk
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
|
COPD Standard Therapy
n=130 participants at risk
Standard COPD treatment according to JRS guideline and GOLD guideline
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Arteriosclerosis Obliterans
|
0.00%
0/130
|
0.77%
1/130
|
|
Respiratory, thoracic and mediastinal disorders
Prostatitis
|
0.77%
1/130
|
0.00%
0/130
|
|
Respiratory, thoracic and mediastinal disorders
Benign Prostatic Hyperplasia
|
0.77%
1/130
|
0.00%
0/130
|
|
Respiratory, thoracic and mediastinal disorders
Haematuria
|
0.77%
1/130
|
0.00%
0/130
|
|
Respiratory, thoracic and mediastinal disorders
Computerised Tomogram Thorax Abnormal
|
0.00%
0/130
|
0.77%
1/130
|
|
Respiratory, thoracic and mediastinal disorders
Pyrexia
|
0.77%
1/130
|
0.00%
0/130
|
|
Respiratory, thoracic and mediastinal disorders
Inguinal Hernia
|
0.00%
0/130
|
0.77%
1/130
|
|
Respiratory, thoracic and mediastinal disorders
Intervertebral Disc Protrusion
|
0.77%
1/130
|
0.00%
0/130
|
|
Respiratory, thoracic and mediastinal disorders
Synovial Cyst
|
0.77%
1/130
|
0.00%
0/130
|
|
Respiratory, thoracic and mediastinal disorders
Optic Ischaemic Neuropathy
|
0.00%
0/130
|
0.77%
1/130
|
|
Respiratory, thoracic and mediastinal disorders
Angle Closure Glaucoma
|
0.00%
0/130
|
0.77%
1/130
|
|
Respiratory, thoracic and mediastinal disorders
Cataract
|
0.00%
0/130
|
1.5%
2/130
|
|
Respiratory, thoracic and mediastinal disorders
Heat Illness
|
0.00%
0/130
|
0.77%
1/130
|
|
Respiratory, thoracic and mediastinal disorders
Tendon Rupture
|
0.77%
1/130
|
0.00%
0/130
|
|
Respiratory, thoracic and mediastinal disorders
Spinal Compression Fracture
|
0.77%
1/130
|
0.00%
0/130
|
|
Respiratory, thoracic and mediastinal disorders
Syncope
|
0.77%
1/130
|
0.00%
0/130
|
|
Respiratory, thoracic and mediastinal disorders
Loss Consciousness
|
0.77%
1/130
|
0.00%
0/130
|
|
Respiratory, thoracic and mediastinal disorders
Cerebral Infarction
|
1.5%
2/130
|
0.00%
0/130
|
|
Respiratory, thoracic and mediastinal disorders
Prostate Cancer
|
0.00%
0/130
|
0.77%
1/130
|
|
Respiratory, thoracic and mediastinal disorders
Gastric Adenoma
|
0.77%
1/130
|
0.00%
0/130
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Cancer
|
0.00%
0/130
|
0.77%
1/130
|
|
Respiratory, thoracic and mediastinal disorders
Lung Neoplasm Malignant
|
1.5%
2/130
|
0.77%
1/130
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Tuberculosis
|
0.00%
0/130
|
1.5%
2/130
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.77%
1/130
|
1.5%
2/130
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Bacterial
|
0.00%
0/130
|
3.8%
5/130
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
4.6%
6/130
|
3.8%
5/130
|
|
Respiratory, thoracic and mediastinal disorders
Organising Pneumonia
|
0.00%
0/130
|
0.77%
1/130
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/130
|
0.77%
1/130
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Respiratory Failure
|
0.00%
0/130
|
0.77%
1/130
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/130
|
0.77%
1/130
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.5%
2/130
|
0.00%
0/130
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
6.2%
8/130
|
15.4%
20/130
|
Other adverse events
| Measure |
Symbicort Turbuhaler
n=130 participants at risk
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
|
COPD Standard Therapy
n=130 participants at risk
Standard COPD treatment according to JRS guideline and GOLD guideline
|
|---|---|---|
|
Psychiatric disorders
Insomnia
|
5.4%
7/130
|
0.77%
1/130
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.4%
7/130
|
0.77%
1/130
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
5.4%
7/130
|
5.4%
7/130
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
4.6%
6/130
|
7.7%
10/130
|
|
Gastrointestinal disorders
Constipation
|
7.7%
10/130
|
10.0%
13/130
|
|
Infections and infestations
Pneumonia
|
6.9%
9/130
|
2.3%
3/130
|
|
Infections and infestations
Pharyngitis
|
6.9%
9/130
|
2.3%
3/130
|
|
Infections and infestations
Bronchitis
|
11.5%
15/130
|
10.0%
13/130
|
|
Infections and infestations
Nasopharyngitis
|
42.3%
55/130
|
39.2%
51/130
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER