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Efficacy and Safety Study of Symbicort® Turbuhaler® Versus Oxis® Turbuhaler® in Chronic Obstructive Pulmonary Disease (COPD) Patients (SUMIRE)

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ClinicalTrials.gov Identifier: NCT01069289
Recruitment Status : Completed
First Posted : February 17, 2010
Results First Posted : October 25, 2012
Last Update Posted : October 25, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Obstructive Pulmonary Disease
Interventions Drug: Budesonide/formoterol (Symbicort Turbuhaler)
Drug: Formoterol (Oxis Turbuhaler)
Enrollment 1293
Recruitment Details The first participant entered the study on 28 January 2010, and the last participant completed the study on 30 March 2011. A total of 1,710 participants were enrolled at 163 centres in 9 countries in Asia and Europe, and 1,293 participants who fulfilled the randomisation criteria were randomised.
Pre-assignment Details The study started with an enrolment visit, Visit 1, 0 to 4 weeks prior to Visit 2, and 1-2 week run-in period before randomization. At Visit 2 participants had to have pre-bronchodilatory forced expiratory volume in one second (FEV1) less than or equal to 50 percent of the predicted normal value.
Arm/Group Title Symbicort Turbuhaler (Experimental) Oxis Turbuhaler (Active Comparator)
Hide Arm/Group Description Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid) Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
Period Title: Overall Study
Started 636 657
Completed 594 601
Not Completed 42 56
Reason Not Completed
Withdrawal by Subject             15             26
Adverse Event             21             28
Eligibility criteria not fulfilled             2             0
Severe non-compliance to protocol             3             2
Due to deteriorating health condition             1             0
Arm/Group Title Symbicort Turbuhaler (Experimental) Oxis Turbuhaler (Active Comparator) Total
Hide Arm/Group Description Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid) Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid) Total of all reporting groups
Overall Number of Baseline Participants 636 657 1293
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 636 participants 657 participants 1293 participants
64.5
(40 to 89)
65.6
(40 to 87)
65.1
(40 to 89)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 636 participants 657 participants 1293 participants
Female
79
  12.4%
64
   9.7%
143
  11.1%
Male
557
  87.6%
593
  90.3%
1150
  88.9%
1.Primary Outcome
Title Pre-dose Forced Expiratory Volume in One Second (FEV1)
Hide Description The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group
Time Frame Before randomization, 0, 4, 8 and 12 weeks after randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.
Arm/Group Title Symbicort Turbuhaler (Experimental) Oxis Turbuhaler (Active Comparator)
Hide Arm/Group Description:
Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
Overall Number of Participants Analyzed 618 635
Geometric Mean (Full Range)
Unit of Measure: percentage of Baseline
104.6
(37.4 to 311.1)
101.5
(35.1 to 218.5)
2.Secondary Outcome
Title 1 Hour Post Dose Forced Expiratory Volume in One Second (FEV1)
Hide Description The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group
Time Frame Before randomization, 0, 4, 8 and 12 weeks after randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.
Arm/Group Title Symbicort Turbuhaler (Experimental) Oxis Turbuhaler (Active Comparator)
Hide Arm/Group Description:
Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
Overall Number of Participants Analyzed 635 657
Geometric Mean (Full Range)
Unit of Measure: percentage of Baseline
113.9
(55.5 to 336.3)
111.2
(51.3 to 203.3)
3.Secondary Outcome
Title Pre-dose Forced Vital Capacity (FVC)
Hide Description The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group
Time Frame Before randomization, 0, 4, 8 and 12 weeks after randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.
Arm/Group Title Symbicort Turbuhaler (Experimental) Oxis Turbuhaler (Active Comparator)
Hide Arm/Group Description:
Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
Overall Number of Participants Analyzed 618 635
Geometric Mean (Full Range)
Unit of Measure: percentage of Baseline
102.2
(57.3 to 313.8)
100.9
(61.5 to 347.6)
4.Secondary Outcome
Title 1 Hour Post-dose Forced Vital Capacity (FVC)
Hide Description The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group
Time Frame Before randomization, 0, 4, 8 and 12 weeks after randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis set for efficacy was based on the Full Analysis Set (FAS. Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.
Arm/Group Title Symbicort Turbuhaler (Experimental) Oxis Turbuhaler (Active Comparator)
Hide Arm/Group Description:
Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
Overall Number of Participants Analyzed 635 657
Geometric Mean (Full Range)
Unit of Measure: percentage of Baseline
110.1
(62.0 to 262.7)
108.7
(63.5 to 272.7)
5.Secondary Outcome
Title Percentage of Participants With Exacerbations
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 12-week randomization treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis set for efficacy was based on the Full Analysis Set (FAS).Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.
Arm/Group Title Symbicort Turbuhaler (Experimental) Oxis Turbuhaler (Active Comparator)
Hide Arm/Group Description:
Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
Overall Number of Participants Analyzed 636 657
Measure Type: Number
Unit of Measure: percentage of participants
11.9 16.9
6.Secondary Outcome
Title Number of Chronic Obstructive Pulmonary Disease (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. Number of COPD exacerbation during 12-week randomization treatment
Time Frame Daily during 12-week randomization treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.
Arm/Group Title Symbicort Turbuhaler (Experimental) Oxis Turbuhaler (Active Comparator)
Hide Arm/Group Description:
Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
Overall Number of Participants Analyzed 636 657
Measure Type: Number
Unit of Measure: event
93 151
7.Secondary Outcome
Title Morning Peak Expiratory Flow(PEF)
Hide Description 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 12-week randomization treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.
Arm/Group Title Symbicort Turbuhaler (Experimental) Oxis Turbuhaler (Active Comparator)
Hide Arm/Group Description:
Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
Overall Number of Participants Analyzed 613 637
Mean (Standard Deviation)
Unit of Measure: Liter/minute (L/min)
4.29  (36.58) -4.78  (30.61)
8.Secondary Outcome
Title Evening Peak Expiratory Flow (PEF)
Hide Description 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 12-week randomization treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.
Arm/Group Title Symbicort Turbuhaler (Experimental) Oxis Turbuhaler (Active Comparator)
Hide Arm/Group Description:
Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
Overall Number of Participants Analyzed 612 637
Mean (Standard Deviation)
Unit of Measure: Liter/minute (L/min)
2.55  (36.57) -5.13  (31.52)
9.Secondary Outcome
Title Total Number of Day With Exacerbation
Hide Description Total number of days with COPD exacerbation for each treatment group
Time Frame Daily during 12-week randomization treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.
Arm/Group Title Symbicort Turbuhaler (Experimental) Oxis Turbuhaler (Active Comparator)
Hide Arm/Group Description:
Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
Overall Number of Participants Analyzed 636 657
Measure Type: Number
Unit of Measure: days
653 1098
10.Secondary Outcome
Title Morning Forced Expiratory Volume in One Second (FEV1)
Hide Description 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 12-week randomization treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.
Arm/Group Title Symbicort Turbuhaler (Experimental) Oxis Turbuhaler (Active Comparator)
Hide Arm/Group Description:
Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
Overall Number of Participants Analyzed 613 637
Mean (Standard Deviation)
Unit of Measure: Liter (L)
0.0244  (0.2136) -0.0312  (0.1712)
11.Secondary Outcome
Title Evening Forced Expiratory Volume in One Second (FEV1)
Hide Description 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 12-week randomization treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.
Arm/Group Title Symbicort Turbuhaler (Experimental) Oxis Turbuhaler (Active Comparator)
Hide Arm/Group Description:
Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
Overall Number of Participants Analyzed 612 637
Mean (Standard Deviation)
Unit of Measure: Liter (L)
0.0176  (0.2268) -0.0324  (0.1724)
12.Secondary Outcome
Title Night-time Awakening Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms
Hide Description Scored 0 to 1 (0 = no awakening and 1 = awakening). 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 12-week randomization treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.
Arm/Group Title Symbicort Turbuhaler (Experimental) Oxis Turbuhaler (Active Comparator)
Hide Arm/Group Description:
Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
Overall Number of Participants Analyzed 628 647
Mean (Standard Deviation)
Unit of Measure: Nights with symptoms
-0.20  (0.67) -0.15  (0.66)
13.Secondary Outcome
Title Breathlessness Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms
Hide Description There are 5 alternatives (scored 0 to 4, with 4 being the most severe condition). The change from Run-in period average to Treatment period average for each treatment group
Time Frame Daily during run-in period and daily during 12-week randomization treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.
Arm/Group Title Symbicort Turbuhaler (Experimental) Oxis Turbuhaler (Active Comparator)
Hide Arm/Group Description:
Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
Overall Number of Participants Analyzed 628 647
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.34  (0.66) -0.23  (0.65)
14.Secondary Outcome
Title Cough Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms
Hide Description There are 5 alternatives (scored 0 to 4, with 4 being the most severe condition). The change from Run-in period average to Treatment period average for each treatment group
Time Frame Daily during run-in period and daily during 12-week randomization treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.
Arm/Group Title Symbicort Turbuhaler (Experimental) Oxis Turbuhaler (Active Comparator)
Hide Arm/Group Description:
Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
Overall Number of Participants Analyzed 628 647
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.24  (0.70) -0.24  (0.68)
15.Secondary Outcome
Title Total Chronic Obstructive Pulmonary Disease (COPD) Symptom Score
Hide Description The Total COPD Symptom score is the sum of the measures night-time awakening, breathlessness and cough, ranges from 0 to 12 with 12 being the most severe. The change from Run-in period average to Treatment period average for each treatment group.
Time Frame Daily during run-in period and daily during 12-week randomization treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.
Arm/Group Title Symbicort Turbuhaler (Experimental) Oxis Turbuhaler (Active Comparator)
Hide Arm/Group Description:
Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
Overall Number of Participants Analyzed 628 647
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.78  (1.62) -0.61  (1.56)
16.Secondary Outcome
Title Use of Rescue Medication
Hide Description 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 12-week randomization treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.
Arm/Group Title Symbicort Turbuhaler (Experimental) Oxis Turbuhaler (Active Comparator)
Hide Arm/Group Description:
Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
Overall Number of Participants Analyzed 628 647
Mean (Standard Deviation)
Unit of Measure: inhalations/day
-0.51  (1.51) -0.26  (1.49)
17.Secondary Outcome
Title St George’s Respiratory Questionnaire (SGRQ) Total Score
Hide Description The change from Run-in period average to Treatment period 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 during 12-week randomization treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.
Arm/Group Title Symbicort Turbuhaler (Experimental) Oxis Turbuhaler (Active Comparator)
Hide Arm/Group Description:
Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
Overall Number of Participants Analyzed 621 634
Mean (Standard Deviation)
Unit of Measure: units on a scale
-4.37  (14.544) -2.90  (13.783)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Symbicort Turbuhaler (Experimental) Oxis Turbuhaler (Active Comparator)
Hide Arm/Group Description Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid) Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
All-Cause Mortality
Symbicort Turbuhaler (Experimental) Oxis Turbuhaler (Active Comparator)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Symbicort Turbuhaler (Experimental) Oxis Turbuhaler (Active Comparator)
Affected / at Risk (%) Affected / at Risk (%)
Total   43/636 (6.76%)   45/657 (6.85%) 
Cardiac disorders     
ACUTE MYOCARDIAL INFARCTION  1  0/636 (0.00%)  1/657 (0.15%) 
ANGINA PECTORIS  1  0/636 (0.00%)  1/657 (0.15%) 
ANGINA UNSTABLE  1  0/636 (0.00%)  1/657 (0.15%) 
CARDIAC FAILURE  1  1/636 (0.16%)  0/657 (0.00%) 
CARDIAC FAILURE CHRONIC  1  1/636 (0.16%)  0/657 (0.00%) 
CARDIOVASCULAR INSUFFICIENCY  1  1/636 (0.16%)  0/657 (0.00%) 
CORONARY ARTERY INSUFFICIENCY  1  0/636 (0.00%)  1/657 (0.15%) 
MYOCARDIAL ISCHAEMIA  1  0/636 (0.00%)  1/657 (0.15%) 
Eye disorders     
AMAUROSIS FUGAX  1  1/636 (0.16%)  0/657 (0.00%) 
CATARACT  1  1/636 (0.16%)  0/657 (0.00%) 
Gastrointestinal disorders     
ABDOMINAL PAIN  1  0/636 (0.00%)  1/657 (0.15%) 
COLITIS ISCHAEMIC  1  0/636 (0.00%)  1/657 (0.15%) 
DIVERTICULUM INTESTINAL HAEMORRHAGIC  1  0/636 (0.00%)  1/657 (0.15%) 
ILEUS  1  1/636 (0.16%)  0/657 (0.00%) 
PANCREATIC MASS  1  0/636 (0.00%)  1/657 (0.15%) 
PERITONITIS  1  1/636 (0.16%)  0/657 (0.00%) 
General disorders     
DEATH  1  1/636 (0.16%)  0/657 (0.00%) 
Hepatobiliary disorders     
CHOLECYSTITIS ACUTE  1  1/636 (0.16%)  0/657 (0.00%) 
Infections and infestations     
APPENDICITIS  1  2/636 (0.31%)  0/657 (0.00%) 
PNEUMONIA BACTERIAL  1  1/636 (0.16%)  1/657 (0.15%) 
BRONCHITIS  1  0/636 (0.00%)  1/657 (0.15%) 
BRONCHOPNEUMONIA  1  1/636 (0.16%)  0/657 (0.00%) 
POSTOPERATIVE ABSCESS  1  1/636 (0.16%)  0/657 (0.00%) 
Investigations     
COMPUTERISED TOMOGRAM THORAX ABNORMAL  1  1/636 (0.16%)  0/657 (0.00%) 
Metabolism and nutrition disorders     
HYPOGLYCAEMIA  1  0/636 (0.00%)  1/657 (0.15%) 
HYPOKALAEMIA  1  1/636 (0.16%)  0/657 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
COLON CANCER  1  1/636 (0.16%)  1/657 (0.15%) 
GASTRIC CANCER  1  0/636 (0.00%)  1/657 (0.15%) 
HEPATIC NEOPLASM MALIGNANT  1  0/636 (0.00%)  1/657 (0.15%) 
LUNG NEOPLASM MALIGNANT  1  1/636 (0.16%)  0/657 (0.00%) 
METASTASES TO LUNG  1  0/636 (0.00%)  1/657 (0.15%) 
Nervous system disorders     
BRAIN STEM STROKE  1  1/636 (0.16%)  0/657 (0.00%) 
HYPOXIC-ISCHAEMIC ENCEPHALOPATHY  1  1/636 (0.16%)  0/657 (0.00%) 
ISCHAEMIC STROKE  1  0/636 (0.00%)  1/657 (0.15%) 
Respiratory, thoracic and mediastinal disorders     
CHRONIC OBSTRUCTIVE PULMONARY DISEASE  1  24/636 (3.77%)  28/657 (4.26%) 
PNEUMOTHORAX  1  1/636 (0.16%)  2/657 (0.30%) 
ACUTE RESPIRATORY FAILURE  1  1/636 (0.16%)  0/657 (0.00%) 
HAEMOPTYSIS  1  0/636 (0.00%)  1/657 (0.15%) 
INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE  1  1/636 (0.16%)  3/657 (0.46%) 
PNEUMONIA  1  3/636 (0.47%)  1/657 (0.15%) 
Vascular disorders     
AORTIC ANEURYSM RUPTURE  1  0/636 (0.00%)  1/657 (0.15%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Symbicort Turbuhaler (Experimental) Oxis Turbuhaler (Active Comparator)
Affected / at Risk (%) Affected / at Risk (%)
Total   61/636 (9.59%)   66/657 (10.05%) 
Infections and infestations     
Nasopharyngitis  1  35/636 (5.50%)  32/657 (4.87%) 
Respiratory, thoracic and mediastinal disorders     
Chronic Obstructive Pulmonary Disease  1  29/636 (4.56%)  36/657 (5.48%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
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: Gerard Lynch
Organization: AstraZeneca
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01069289     History of Changes
Other Study ID Numbers: D589DC00007
First Submitted: February 11, 2010
First Posted: February 17, 2010
Results First Submitted: March 21, 2012
Results First Posted: October 25, 2012
Last Update Posted: October 25, 2012