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Trial record 14 of 183 for:    Foradil Combi OR symbicort OR (Budesonide AND formeterol)

A Safety and Efficacy Study of Symbicort Turbuhaler Compared With Standard Chronic Obstructive Pulmonary Disease (COPD) Treatment in Japan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01070784
Recruitment Status : Completed
First Posted : February 18, 2010
Results First Posted : December 5, 2013
Last Update Posted : April 29, 2014
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Obstructive Pulmonary Disease
Interventions Drug: Symbicort Turbuhaler (Budesonide/formoterol)
Drug: Drug: any available COPD treatment; investigator to decide
Enrollment 328
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.
Arm/Group Title Symbicort Turbuhaler COPD Standard Therapy
Hide Arm/Group Description Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily Standard COPD treatment according to JRS guideline and GOLD guideline
Period Title: Overall Study
Started 130 130
Completed 110 112
Not Completed 20 18
Reason Not Completed
Withdrawal by Subject             6             9
Adverse Event             14             9
Arm/Group Title Symbicort Turbuhaler COPD Standard Therapy Total
Hide Arm/Group Description Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily Standard COPD treatment according to JRS guideline and GOLD guideline Total of all reporting groups
Overall Number of Baseline Participants 130 130 260
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 130 participants 130 participants 260 participants
70.1
(40 to 87)
71.5
(54 to 85)
70.8
(40 to 87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 130 participants 130 participants 260 participants
Female
5
   3.8%
4
   3.1%
9
   3.5%
Male
125
  96.2%
126
  96.9%
251
  96.5%
1.Primary Outcome
Title Clinical Laboratory Test: Haematology -Erythrocytes
Hide Description Mean change from Baseline
Time Frame Baseline and 52 week after
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Symbicort Turbuhaler Arm 2 - COPD Standard Therapy
Hide Arm/Group Description:
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
Standard COPD treatment according to JRS guideline and GOLD guideline
Overall Number of Participants Analyzed 124 120
Mean (Standard Deviation)
Unit of Measure: *10000/μl
-7.6  (23.9) -0.1  (22.9)
2.Primary Outcome
Title Clinical Laboratory Test: Haematology -Haemoglobin
Hide Description Change from baseline
Time Frame Baseline and 52 week after
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Symbicort Turbuhaler Arm 2 - COPD Standard Therapy
Hide Arm/Group Description:
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
Standard COPD treatment according to JRS guideline and GOLD guideline
Overall Number of Participants Analyzed 124 120
Mean (Standard Deviation)
Unit of Measure: g/dL
-0.22  (0.74) -0.05  (0.75)
3.Primary Outcome
Title Clinical Laboratory Test: Haematology -Leucocytes
Hide Description Change from baseline
Time Frame Baseline and 52 week after
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Symbicort Turbuhaler Arm 2 - COPD Standard Therapy
Hide Arm/Group Description:
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
Standard COPD treatment according to JRS guideline and GOLD guideline
Overall Number of Participants Analyzed 123 120
Mean (Standard Deviation)
Unit of Measure: /microliter(mcl)
160.8  (1704.0) -184.8  (1238.2)
4.Primary Outcome
Title Clinical Laboratory Test: Haematology -Platelet Count
Hide Description Change from baseline
Time Frame Baseline and 52 week after
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Symbicort Turbuhaler Arm 2 - COPD Standard Therapy
Hide Arm/Group Description:
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
Standard COPD treatment according to JRS guideline and GOLD guideline
Overall Number of Participants Analyzed 120 117
Mean (Standard Deviation)
Unit of Measure: *10000/μl
0.86  (3.03) 0.12  (4.04)
5.Primary Outcome
Title Clinical Laboratory Test: Haematology -Eosinophils
Hide Description Change from baseline
Time Frame Baseline and 52 week after
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Symbicort Turbuhaler Arm 2 - COPD Standard Therapy
Hide Arm/Group Description:
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
Standard COPD treatment according to JRS guideline and GOLD guideline
Overall Number of Participants Analyzed 123 120
Mean (Standard Deviation)
Unit of Measure: percentage of Eosinophils
-0.52  (2.68) 0.14  (1.91)
6.Primary Outcome
Title Clinical Laboratory Test: Haematology -Basophils
Hide Description Change from baseline
Time Frame Baseline and 52 week after
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Symbicort Turbuhaler Arm 2 - COPD Standard Therapy
Hide Arm/Group Description:
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
Standard COPD treatment according to JRS guideline and GOLD guideline
Overall Number of Participants Analyzed 123 120
Mean (Standard Deviation)
Unit of Measure: percentage of Basophils
-0.06  (0.37) -0.06  (0.35)
7.Primary Outcome
Title Clinical Laboratory Test: Haematology -Lymphocytes
Hide Description Change from baseline
Time Frame Baseline and 52 week after
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Symbicort Turbuhaler Arm 2 - COPD Standard Therapy
Hide Arm/Group Description:
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
Standard COPD treatment according to JRS guideline and GOLD guideline
Overall Number of Participants Analyzed 123 120
Mean (Standard Deviation)
Unit of Measure: percentage of Lymphocytes
-5.47  (6.56) -3.24  (7.00)
8.Primary Outcome
Title Clinical Laboratory Test: Haematology -Monocytes
Hide Description Change from baseline
Time Frame Baseline and 52 week after
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Symbicort Turbuhaler Arm 2 - COPD Standard Therapy
Hide Arm/Group Description:
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
Standard COPD treatment according to JRS guideline and GOLD guideline
Overall Number of Participants Analyzed 123 120
Mean (Standard Deviation)
Unit of Measure: percentage of Monocytes
0.29  (1.41) -0.03  (1.35)
9.Primary Outcome
Title Clinical Laboratory Test: Haematology -Neutrophils
Hide Description Change from baseline
Time Frame Baseline and 52 week after
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Symbicort Turbuhaler Arm 2 - COPD Standard Therapy
Hide Arm/Group Description:
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
Standard COPD treatment according to JRS guideline and GOLD guideline
Overall Number of Participants Analyzed 111 97
Mean (Standard Deviation)
Unit of Measure: percentage of Neutrophils
5.78  (7.16) 2.92  (7.64)
10.Primary Outcome
Title Clinical Laboratory Test: Clinical Chemistry- S-Alanine Aminotransferase
Hide Description Change from baseline
Time Frame Baseline and 52 week after
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Symbicort Turbuhaler Arm 2 - COPD Standard Therapy
Hide Arm/Group Description:
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
Standard COPD treatment according to JRS guideline and GOLD guideline
Overall Number of Participants Analyzed 124 119
Mean (Standard Deviation)
Unit of Measure: U/L
0.5  (7.6) 1.5  (6.6)
11.Primary Outcome
Title Clinical Laboratory Test: Clinical Chemistry- S-Aspartate Aminotransferase
Hide Description Change from baseline
Time Frame Baseline and 52 week after
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Symbicort Turbuhaler Arm 2 - COPD Standard Therapy
Hide Arm/Group Description:
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
Standard COPD treatment according to JRS guideline and GOLD guideline
Overall Number of Participants Analyzed 124 119
Mean (Standard Deviation)
Unit of Measure: U/L
0.0  (7.6) 1.1  (6.5)
12.Primary Outcome
Title Clinical Laboratory Test: Clinical Chemistry- S-Alkaline Phosphatase (ALP)
Hide Description Change from baseline
Time Frame Baseline and 52 week after
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Symbicort Turbuhaler Arm 2 - COPD Standard Therapy
Hide Arm/Group Description:
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
Standard COPD treatment according to JRS guideline and GOLD guideline
Overall Number of Participants Analyzed 124 119
Mean (Standard Deviation)
Unit of Measure: U/L
1.3  (38.4) 8.2  (45.9)
13.Primary Outcome
Title Clinical Laboratory Test: Clinical Chemistry- S-Creatinine
Hide Description Change from baseline
Time Frame Baseline and 52 week after
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Symbicort Turbuhaler Arm 2 - COPD Standard Therapy
Hide Arm/Group Description:
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
Standard COPD treatment according to JRS guideline and GOLD guideline
Overall Number of Participants Analyzed 124 119
Mean (Standard Deviation)
Unit of Measure: mg/dL
0.003  (0.106) -0.017  (0.091)
14.Primary Outcome
Title Clinical Laboratory Test: Clinical Chemistry- S-Total Bilirubin
Hide Description Change from baseline
Time Frame Baseline and 52 week after
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Symbicort Turbuhaler Arm 2 - COPD Standard Therapy
Hide Arm/Group Description:
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
Standard COPD treatment according to JRS guideline and GOLD guideline
Overall Number of Participants Analyzed 124 119
Mean (Standard Deviation)
Unit of Measure: mg/dL
0.05  (0.25) 0.00  (0.18)
15.Primary Outcome
Title Clinical Laboratory Test: Clinical Chemistry- S-Sodium
Hide Description Change from baseline
Time Frame Baseline and 52 week after
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Symbicort Turbuhaler Arm 2 - COPD Standard Therapy
Hide Arm/Group Description:
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
Standard COPD treatment according to JRS guideline and GOLD guideline
Overall Number of Participants Analyzed 124 119
Mean (Standard Deviation)
Unit of Measure: mEq/L
-0.8  (2.0) -0.6  (1.7)
16.Primary Outcome
Title Clinical Laboratory Test: Clinical Chemistry- S-Potassium
Hide Description Change from baseline
Time Frame Baseline and 52 week after
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Symbicort Turbuhaler Arm 2 - COPD Standard Therapy
Hide Arm/Group Description:
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
Standard COPD treatment according to JRS guideline and GOLD guideline
Overall Number of Participants Analyzed 124 119
Mean (Standard Deviation)
Unit of Measure: mEq/L
-0.11  (0.34) -0.08  (0.37)
17.Primary Outcome
Title Clinical Laboratory Test: Clinical Chemistry- S- Calcium
Hide Description Change from baseline
Time Frame Baseline and 52 week after
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Symbicort Turbuhaler Arm 2 - COPD Standard Therapy
Hide Arm/Group Description:
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
Standard COPD treatment according to JRS guideline and GOLD guideline
Overall Number of Participants Analyzed 124 119
Mean (Standard Deviation)
Unit of Measure: mg/dL
0.02  (0.34) 0.01  (0.33)
18.Primary Outcome
Title Clinical Laboratory Test: Clinical Chemistry- S-Albumin
Hide Description Change from baseline
Time Frame Baseline and 52 week after
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Symbicort Turbuhaler Arm 2 - COPD Standard Therapy
Hide Arm/Group Description:
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
Standard COPD treatment according to JRS guideline and GOLD guideline
Overall Number of Participants Analyzed 124 119
Mean (Standard Deviation)
Unit of Measure: g/dL
0.03  (0.24) 0.04  (0.26)
19.Primary Outcome
Title Clinical Laboratory Test: Clinical Chemistry- S-Protein, Total
Hide Description Change from baseline
Time Frame Baseline and 52 week after
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Symbicort Turbuhaler Arm 2 - COPD Standard Therapy
Hide Arm/Group Description:
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
Standard COPD treatment according to JRS guideline and GOLD guideline
Overall Number of Participants Analyzed 124 119
Mean (Standard Deviation)
Unit of Measure: g/dL
0.01  (0.35) 0.02  (0.37)
20.Primary Outcome
Title Clinical Laboratory Test: Clinical Chemistry- S-C-Reactive Protein
Hide Description Change from baseline
Time Frame Baseline and 52 week after
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Symbicort Turbuhaler Arm 2 - COPD Standard Therapy
Hide Arm/Group Description:
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
Standard COPD treatment according to JRS guideline and GOLD guideline
Overall Number of Participants Analyzed 124 119
Mean (Standard Deviation)
Unit of Measure: mg/dL
0.243  (1.291) 0.224  (1.423)
21.Primary Outcome
Title Clinical Laboratory Test: Clinical Chemistry- S-Urea Nitrogen
Hide Description Change from baseline
Time Frame Baseline and 52 week after
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Symbicort Turbuhaler Arm 2 - COPD Standard Therapy
Hide Arm/Group Description:
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
Standard COPD treatment according to JRS guideline and GOLD guideline
Overall Number of Participants Analyzed 124 119
Mean (Standard Deviation)
Unit of Measure: mg/dL
-0.51  (4.09) -0.64  (3.32)
22.Primary Outcome
Title Vital Signs- Sitting Systolic Blood Pressure(SBP)
Hide Description Change from baseline
Time Frame Baseline and 52 week after
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Symbicort Turbuhaler Arm 2 - COPD Standard Therapy
Hide Arm/Group Description:
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
Standard COPD treatment according to JRS guideline and GOLD guideline
Overall Number of Participants Analyzed 126 125
Mean (Standard Deviation)
Unit of Measure: mmHg
-0.8  (16.2) -3.2  (15.0)
23.Primary Outcome
Title Vital Signs- Sitting Diastolic Blood Pressure(DBP)
Hide Description Change from baseline
Time Frame Baseline and 52 week after
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Symbicort Turbuhaler Arm 2 - COPD Standard Therapy
Hide Arm/Group Description:
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
Standard COPD treatment according to JRS guideline and GOLD guideline
Overall Number of Participants Analyzed 126 125
Mean (Standard Deviation)
Unit of Measure: mmHg
-0.8  (11.2) -1.3  (10.7)
24.Primary Outcome
Title Vital Signs- Pulse Rate
Hide Description Change from baseline
Time Frame Baseline and 52 week after
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Symbicort Turbuhaler Arm 2 - COPD Standard Therapy
Hide Arm/Group Description:
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
Standard COPD treatment according to JRS guideline and GOLD guideline
Overall Number of Participants Analyzed 126 125
Mean (Standard Deviation)
Unit of Measure: beats/minute
3.2  (11.1) 3.1  (11.5)
25.Primary Outcome
Title ECG Variables - Heart Rate
Hide Description Change from baseline
Time Frame Baseline and 52 week after
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Symbicort Turbuhaler Arm 2 - COPD Standard Therapy
Hide Arm/Group Description:
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
Standard COPD treatment according to JRS guideline and GOLD guideline
Overall Number of Participants Analyzed 125 121
Mean (Standard Deviation)
Unit of Measure: beats/minute
3.6  (11.4) 3.4  (10.9)
26.Primary Outcome
Title ECG Variables - QT Interval
Hide Description Change from baseline
Time Frame Baseline and 52 week after
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Symbicort Turbuhaler Arm 2 - COPD Standard Therapy
Hide Arm/Group Description:
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
Standard COPD treatment according to JRS guideline and GOLD guideline
Overall Number of Participants Analyzed 125 121
Mean (Standard Deviation)
Unit of Measure: ms
-4.5  (23.1) -7.5  (21.2)
27.Primary Outcome
Title ECG Variables - QTcB Interval
Hide Description Change from baseline
Time Frame Baseline and 52 week after
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Symbicort Turbuhaler Arm 2 - COPD Standard Therapy
Hide Arm/Group Description:
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
Standard COPD treatment according to JRS guideline and GOLD guideline
Overall Number of Participants Analyzed 125 121
Mean (Standard Deviation)
Unit of Measure: ms
3.6  (20.9) 2.4  (22.6)
28.Primary Outcome
Title ECG Variables - QTcF Interval
Hide Description Change from baseline
Time Frame Baseline and 52 week after
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Symbicort Turbuhaler Arm 2 - COPD Standard Therapy
Hide Arm/Group Description:
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
Standard COPD treatment according to JRS guideline and GOLD guideline
Overall Number of Participants Analyzed 125 121
Mean (Standard Deviation)
Unit of Measure: ms
0.7  (16.3) -1.1  (17.4)
29.Primary Outcome
Title ECG Variables - RR Interval
Hide Description Change from baseline
Time Frame Baseline and 52 week after
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Symbicort Turbuhaler Arm 2 - COPD Standard Therapy
Hide Arm/Group Description:
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
Standard COPD treatment according to JRS guideline and GOLD guideline
Overall Number of Participants Analyzed 125 121
Mean (Standard Deviation)
Unit of Measure: ms
-30.9  (121.4) -43.8  (115.1)
30.Secondary Outcome
Title Chronic Obstructive Pulmonary Disease (COPD) symptoms_Night-time Awakening
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Symbicort Turbuhaler Arm 2 - COPD Standard Therapy
Hide Arm/Group Description:
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
Standard COPD treatment according to JRS guideline and GOLD guideline
Overall Number of Participants Analyzed 130 130
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.0  (0.5) -0.1  (0.4)
31.Secondary Outcome
Title Chronic Obstructive Pulmonary Disease (COPD) symptoms_Breathlessness
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Symbicort Turbuhaler Arm 2 - COPD Standard Therapy
Hide Arm/Group Description:
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
Standard COPD treatment according to JRS guideline and GOLD guideline
Overall Number of Participants Analyzed 130 130
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.2  (0.7) -0.1  (0.7)
32.Secondary Outcome
Title Chronic Obstructive Pulmonary Disease (COPD) symptoms_cough
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Symbicort Turbuhaler Arm 2 - COPD Standard Therapy
Hide Arm/Group Description:
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
Standard COPD treatment according to JRS guideline and GOLD guideline
Overall Number of Participants Analyzed 130 130
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.2  (0.7) -0.2  (0.7)
33.Secondary Outcome
Title Forced Expiratory Volume in 1 Second (FEV1) Measured With the Spirometer at the Clinic
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Symbicort Turbuhaler Arm 2 - COPD Standard Therapy
Hide Arm/Group Description:
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
Standard COPD treatment according to JRS guideline and GOLD guideline
Overall Number of Participants Analyzed 129 129
Geometric Mean (Full Range)
Unit of Measure: percentage of Baseline
104.25
(60.8 to 182.9)
98.43
(35.8 to 168.2)
34.Secondary Outcome
Title Forced Vital Capacity (FVC) Measured With the Spirometer at the Clinic
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Symbicort Turbuhaler Arm 2 - COPD Standard Therapy
Hide Arm/Group Description:
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
Standard COPD treatment according to JRS guideline and GOLD guideline
Overall Number of Participants Analyzed 129 129
Geometric Mean (Full Range)
Unit of Measure: percentage of Baseline
102.51
(77.8 to 141.5)
100.04
(67.6 to 158.2)
35.Secondary Outcome
Title Time to First COPD Exacerbation
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Symbicort Turbuhaler Arm 2 - COPD Standard Therapy
Hide Arm/Group Description:
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
Standard COPD treatment according to JRS guideline and GOLD guideline
Overall Number of Participants Analyzed 130 130
Measure Type: Number
Unit of Measure: Percentage of participants
20.0 31.5
36.Secondary Outcome
Title Number of COPD Exacerbations Over the Study Treatment Period
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Symbicort Turbuhaler Arm 2 - COPD Standard Therapy
Hide Arm/Group Description:
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
Standard COPD treatment according to JRS guideline and GOLD guideline
Overall Number of Participants Analyzed 130 130
Measure Type: Number
Unit of Measure: event
41 105
37.Secondary Outcome
Title Rescue Medication Use
Hide Description The change from run-in period and daily during 52-week randomization treatment
Time Frame Daily during 52-week randomization treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Symbicort Turbuhaler Arm 2 - COPD Standard Therapy
Hide Arm/Group Description:
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
Standard COPD treatment according to JRS guideline and GOLD guideline
Overall Number of Participants Analyzed 130 130
Mean (Standard Deviation)
Unit of Measure: innhalation/day
-0.2  (1.0) 0.0  (1.4)
38.Secondary Outcome
Title Health Related Quality of Life (HRQL) Based on the St. George’s Respiratory Questionnaire (SGRQ)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Symbicort Turbuhaler Arm 2 - COPD Standard Therapy
Hide Arm/Group Description:
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
Standard COPD treatment according to JRS guideline and GOLD guideline
Overall Number of Participants Analyzed 130 130
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.03  (8.56) -0.42  (7.47)
39.Secondary Outcome
Title Morning Peak Expiratory Flow (PEF) Measured at Home
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Symbicort Turbuhaler Arm 2 - COPD Standard Therapy
Hide Arm/Group Description:
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
Standard COPD treatment according to JRS guideline and GOLD guideline
Overall Number of Participants Analyzed 126 123
Mean (Standard Deviation)
Unit of Measure: Liter/minute(L/min)
5.9  (31.8) 5.7  (30.9)
40.Secondary Outcome
Title Evening Peak Expiratory Flow (PEF) Measured at Home
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Symbicort Turbuhaler Arm 2 - COPD Standard Therapy
Hide Arm/Group Description:
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
Standard COPD treatment according to JRS guideline and GOLD guideline
Overall Number of Participants Analyzed 125 122
Mean (Standard Deviation)
Unit of Measure: Liter/minute(L/min)
2.7  (30.0) 5.2  (29.3)
41.Secondary Outcome
Title Morning FEV1 Measured by the Subjects at Home
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Symbicort Turbuhaler Arm 2 - COPD Standard Therapy
Hide Arm/Group Description:
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
Standard COPD treatment according to JRS guideline and GOLD guideline
Overall Number of Participants Analyzed 126 123
Mean (Standard Deviation)
Unit of Measure: Liter(L)
0.017  (0.147) 0.006  (0.171)
42.Secondary Outcome
Title Evening FEV1 Measured by the Subjects at Home
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Symbicort Turbuhaler Arm 2 - COPD Standard Therapy
Hide Arm/Group Description:
Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
Standard COPD treatment according to JRS guideline and GOLD guideline
Overall Number of Participants Analyzed 125 122
Mean (Standard Deviation)
Unit of Measure: Liter(L)
0.006  (0.142) 0.010  (0.156)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Symbicort Turbuhaler COPD Standard Therapy
Hide Arm/Group Description Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily Standard COPD treatment according to JRS guideline and GOLD guideline
All-Cause Mortality
Symbicort Turbuhaler COPD Standard Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Symbicort Turbuhaler COPD Standard Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   25/130 (19.23%)   34/130 (26.15%) 
Respiratory, thoracic and mediastinal disorders     
Arteriosclerosis Obliterans  1  0/130 (0.00%)  1/130 (0.77%) 
Prostatitis  1  1/130 (0.77%)  0/130 (0.00%) 
Benign Prostatic Hyperplasia  1  1/130 (0.77%)  0/130 (0.00%) 
Haematuria  1  1/130 (0.77%)  0/130 (0.00%) 
Computerised Tomogram Thorax Abnormal  1  0/130 (0.00%)  1/130 (0.77%) 
Pyrexia  1  1/130 (0.77%)  0/130 (0.00%) 
Inguinal Hernia  1  0/130 (0.00%)  1/130 (0.77%) 
Intervertebral Disc Protrusion  1  1/130 (0.77%)  0/130 (0.00%) 
Synovial Cyst  1  1/130 (0.77%)  0/130 (0.00%) 
Optic Ischaemic Neuropathy  1  0/130 (0.00%)  1/130 (0.77%) 
Angle Closure Glaucoma  1  0/130 (0.00%)  1/130 (0.77%) 
Cataract  1  0/130 (0.00%)  2/130 (1.54%) 
Heat Illness  1  0/130 (0.00%)  1/130 (0.77%) 
Tendon Rupture  1  1/130 (0.77%)  0/130 (0.00%) 
Spinal Compression Fracture  1  1/130 (0.77%)  0/130 (0.00%) 
Syncope  1  1/130 (0.77%)  0/130 (0.00%) 
Loss Consciousness  1  1/130 (0.77%)  0/130 (0.00%) 
Cerebral Infarction  1  2/130 (1.54%)  0/130 (0.00%) 
Prostate Cancer  1  0/130 (0.00%)  1/130 (0.77%) 
Gastric Adenoma  1/130 (0.77%)  0/130 (0.00%) 
Laryngeal Cancer  1  0/130 (0.00%)  1/130 (0.77%) 
Lung Neoplasm Malignant  1  2/130 (1.54%)  1/130 (0.77%) 
Pulmonary Tuberculosis  1  0/130 (0.00%)  2/130 (1.54%) 
Bronchitis  1/130 (0.77%)  2/130 (1.54%) 
Pneumonia Bacterial  1  0/130 (0.00%)  5/130 (3.85%) 
Pneumonia  1  6/130 (4.62%)  5/130 (3.85%) 
Organising Pneumonia  1  0/130 (0.00%)  1/130 (0.77%) 
Pleurisy  1  0/130 (0.00%)  1/130 (0.77%) 
Chronic Respiratory Failure  1  0/130 (0.00%)  1/130 (0.77%) 
Asthma  1  0/130 (0.00%)  1/130 (0.77%) 
Pneumothorax  1  2/130 (1.54%)  0/130 (0.00%) 
Chronic obstructive pulmonary disease  1  8/130 (6.15%)  20/130 (15.38%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Symbicort Turbuhaler COPD Standard Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   75/130 (57.69%)   72/130 (55.38%) 
Gastrointestinal disorders     
Constipation  1  10/130 (7.69%)  13/130 (10.00%) 
Infections and infestations     
Pneumonia  1  9/130 (6.92%)  3/130 (2.31%) 
Pharyngitis  1  9/130 (6.92%)  3/130 (2.31%) 
Bronchitis  1  15/130 (11.54%)  13/130 (10.00%) 
Nasopharyngitis  1  55/130 (42.31%)  51/130 (39.23%) 
Musculoskeletal and connective tissue disorders     
Back Pain  1  6/130 (4.62%)  10/130 (7.69%) 
Psychiatric disorders     
Insomnia  1  7/130 (5.38%)  1/130 (0.77%) 
Respiratory, thoracic and mediastinal disorders     
Dysphonia  1  7/130 (5.38%)  1/130 (0.77%) 
Chronic Obstructive Pulmonary Disease  1  7/130 (5.38%)  7/130 (5.38%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Name/Title: Goran Eckerwall, MSD
Organization: AstraZeneca
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01070784     History of Changes
Other Study ID Numbers: D589DC00008
First Submitted: February 11, 2010
First Posted: February 18, 2010
Results First Submitted: October 8, 2012
Results First Posted: December 5, 2013
Last Update Posted: April 29, 2014