Trial Outcomes & Findings for Efficacy and Safety Study of Symbicort® Turbuhaler® Versus Oxis® Turbuhaler® in Chronic Obstructive Pulmonary Disease (COPD) Patients (NCT NCT01069289)
NCT ID: NCT01069289
Last Updated: 2012-10-25
Results Overview
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
COMPLETED
PHASE3
1293 participants
Before randomization, 0, 4, 8 and 12 weeks after randomization
2012-10-25
Participant Flow
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.
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.
Participant milestones
| Measure |
Symbicort Turbuhaler (Experimental)
Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
|
Oxis Turbuhaler (Active Comparator)
Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
|
|---|---|---|
|
Overall Study
STARTED
|
636
|
657
|
|
Overall Study
COMPLETED
|
594
|
601
|
|
Overall Study
NOT COMPLETED
|
42
|
56
|
Reasons for withdrawal
| Measure |
Symbicort Turbuhaler (Experimental)
Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
|
Oxis Turbuhaler (Active Comparator)
Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
15
|
26
|
|
Overall Study
Adverse Event
|
21
|
28
|
|
Overall Study
Eligibility criteria not fulfilled
|
2
|
0
|
|
Overall Study
Severe non-compliance to protocol
|
3
|
2
|
|
Overall Study
Due to deteriorating health condition
|
1
|
0
|
Baseline Characteristics
Efficacy and Safety Study of Symbicort® Turbuhaler® Versus Oxis® Turbuhaler® in Chronic Obstructive Pulmonary Disease (COPD) Patients
Baseline characteristics by cohort
| Measure |
Symbicort Turbuhaler (Experimental)
n=636 Participants
Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
|
Oxis Turbuhaler (Active Comparator)
n=657 Participants
Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
|
Total
n=1293 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
64.5 Years
n=5 Participants
|
65.6 Years
n=7 Participants
|
65.1 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
79 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
557 Participants
n=5 Participants
|
593 Participants
n=7 Participants
|
1150 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Before randomization, 0, 4, 8 and 12 weeks after randomizationPopulation: 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.
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
Outcome measures
| Measure |
Symbicort Turbuhaler (Experimental)
n=618 Participants
Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
|
Oxis Turbuhaler (Active Comparator)
n=635 Participants
Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
|
|---|---|---|
|
Pre-dose Forced Expiratory Volume in One Second (FEV1)
|
104.6 percentage of Baseline
Interval 37.4 to 311.1
|
101.5 percentage of Baseline
Interval 35.1 to 218.5
|
SECONDARY outcome
Timeframe: Before randomization, 0, 4, 8 and 12 weeks after randomizationPopulation: 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.
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
Outcome measures
| Measure |
Symbicort Turbuhaler (Experimental)
n=635 Participants
Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
|
Oxis Turbuhaler (Active Comparator)
n=657 Participants
Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
|
|---|---|---|
|
1 Hour Post Dose Forced Expiratory Volume in One Second (FEV1)
|
113.9 percentage of Baseline
Interval 55.5 to 336.3
|
111.2 percentage of Baseline
Interval 51.3 to 203.3
|
SECONDARY outcome
Timeframe: Before randomization, 0, 4, 8 and 12 weeks after randomizationPopulation: 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.
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
Outcome measures
| Measure |
Symbicort Turbuhaler (Experimental)
n=618 Participants
Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
|
Oxis Turbuhaler (Active Comparator)
n=635 Participants
Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
|
|---|---|---|
|
Pre-dose Forced Vital Capacity (FVC)
|
102.2 percentage of Baseline
Interval 57.3 to 313.8
|
100.9 percentage of Baseline
Interval 61.5 to 347.6
|
SECONDARY outcome
Timeframe: Before randomization, 0, 4, 8 and 12 weeks after randomizationPopulation: 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.
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
Outcome measures
| Measure |
Symbicort Turbuhaler (Experimental)
n=635 Participants
Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
|
Oxis Turbuhaler (Active Comparator)
n=657 Participants
Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
|
|---|---|---|
|
1 Hour Post-dose Forced Vital Capacity (FVC)
|
110.1 percentage of Baseline
Interval 62.0 to 262.7
|
108.7 percentage of Baseline
Interval 63.5 to 272.7
|
SECONDARY outcome
Timeframe: Daily during 12-week randomization treatmentPopulation: 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.
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.
Outcome measures
| Measure |
Symbicort Turbuhaler (Experimental)
n=636 Participants
Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
|
Oxis Turbuhaler (Active Comparator)
n=657 Participants
Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
|
|---|---|---|
|
Percentage of Participants With Exacerbations
|
11.9 percentage of participants
|
16.9 percentage of participants
|
SECONDARY outcome
Timeframe: Daily during 12-week randomization treatmentPopulation: 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.
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
Outcome measures
| Measure |
Symbicort Turbuhaler (Experimental)
n=636 Participants
Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
|
Oxis Turbuhaler (Active Comparator)
n=657 Participants
Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
|
|---|---|---|
|
Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
|
93 event
|
151 event
|
SECONDARY outcome
Timeframe: Daily during run-in period and daily during 12-week randomization treatmentPopulation: 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.
The change from Run-in period average to Treatment period average for each treatment group
Outcome measures
| Measure |
Symbicort Turbuhaler (Experimental)
n=613 Participants
Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
|
Oxis Turbuhaler (Active Comparator)
n=637 Participants
Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
|
|---|---|---|
|
Morning Peak Expiratory Flow(PEF)
|
4.29 Liter/minute (L/min)
Standard Deviation 36.58
|
-4.78 Liter/minute (L/min)
Standard Deviation 30.61
|
SECONDARY outcome
Timeframe: Daily during run-in period and daily during 12-week randomization treatmentPopulation: 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.
The change from Run-in period average to Treatment period average for each treatment group
Outcome measures
| Measure |
Symbicort Turbuhaler (Experimental)
n=612 Participants
Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
|
Oxis Turbuhaler (Active Comparator)
n=637 Participants
Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
|
|---|---|---|
|
Evening Peak Expiratory Flow (PEF)
|
2.55 Liter/minute (L/min)
Standard Deviation 36.57
|
-5.13 Liter/minute (L/min)
Standard Deviation 31.52
|
SECONDARY outcome
Timeframe: Daily during 12-week randomization treatmentPopulation: 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.
Total number of days with COPD exacerbation for each treatment group
Outcome measures
| Measure |
Symbicort Turbuhaler (Experimental)
n=636 Participants
Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
|
Oxis Turbuhaler (Active Comparator)
n=657 Participants
Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
|
|---|---|---|
|
Total Number of Day With Exacerbation
|
653 days
|
1098 days
|
SECONDARY outcome
Timeframe: Daily during run-in period and daily during 12-week randomization treatmentPopulation: 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.
The change from Run-in period average to Treatment period average for each treatment group
Outcome measures
| Measure |
Symbicort Turbuhaler (Experimental)
n=613 Participants
Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
|
Oxis Turbuhaler (Active Comparator)
n=637 Participants
Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
|
|---|---|---|
|
Morning Forced Expiratory Volume in One Second (FEV1)
|
0.0244 Liter (L)
Standard Deviation 0.2136
|
-0.0312 Liter (L)
Standard Deviation 0.1712
|
SECONDARY outcome
Timeframe: Daily during run-in period and daily during 12-week randomization treatmentPopulation: 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.
The change from Run-in period average to Treatment period average for each treatment group
Outcome measures
| Measure |
Symbicort Turbuhaler (Experimental)
n=612 Participants
Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
|
Oxis Turbuhaler (Active Comparator)
n=637 Participants
Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
|
|---|---|---|
|
Evening Forced Expiratory Volume in One Second (FEV1)
|
0.0176 Liter (L)
Standard Deviation 0.2268
|
-0.0324 Liter (L)
Standard Deviation 0.1724
|
SECONDARY outcome
Timeframe: Daily during run-in period and daily during 12-week randomization treatmentPopulation: 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.
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
Outcome measures
| Measure |
Symbicort Turbuhaler (Experimental)
n=628 Participants
Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
|
Oxis Turbuhaler (Active Comparator)
n=647 Participants
Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
|
|---|---|---|
|
Night-time Awakening Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms
|
-0.20 Nights with symptoms
Standard Deviation 0.67
|
-0.15 Nights with symptoms
Standard Deviation 0.66
|
SECONDARY outcome
Timeframe: Daily during run-in period and daily during 12-week randomization treatmentPopulation: 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.
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
Outcome measures
| Measure |
Symbicort Turbuhaler (Experimental)
n=628 Participants
Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
|
Oxis Turbuhaler (Active Comparator)
n=647 Participants
Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
|
|---|---|---|
|
Breathlessness Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms
|
-0.34 units on a scale
Standard Deviation 0.66
|
-0.23 units on a scale
Standard Deviation 0.65
|
SECONDARY outcome
Timeframe: Daily during run-in period and daily during 12-week randomization treatmentPopulation: 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.
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
Outcome measures
| Measure |
Symbicort Turbuhaler (Experimental)
n=628 Participants
Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
|
Oxis Turbuhaler (Active Comparator)
n=647 Participants
Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
|
|---|---|---|
|
Cough Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms
|
-0.24 units on a scale
Standard Deviation 0.70
|
-0.24 units on a scale
Standard Deviation 0.68
|
SECONDARY outcome
Timeframe: Daily during run-in period and daily during 12-week randomization treatmentPopulation: 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.
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.
Outcome measures
| Measure |
Symbicort Turbuhaler (Experimental)
n=628 Participants
Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
|
Oxis Turbuhaler (Active Comparator)
n=647 Participants
Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
|
|---|---|---|
|
Total Chronic Obstructive Pulmonary Disease (COPD) Symptom Score
|
-0.78 units on a scale
Standard Deviation 1.62
|
-0.61 units on a scale
Standard Deviation 1.56
|
SECONDARY outcome
Timeframe: Daily during run-in period and daily during 12-week randomization treatmentPopulation: 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.
The change from Run-in period average to Treatment period average for each treatment group.
Outcome measures
| Measure |
Symbicort Turbuhaler (Experimental)
n=628 Participants
Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
|
Oxis Turbuhaler (Active Comparator)
n=647 Participants
Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
|
|---|---|---|
|
Use of Rescue Medication
|
-0.51 inhalations/day
Standard Deviation 1.51
|
-0.26 inhalations/day
Standard Deviation 1.49
|
SECONDARY outcome
Timeframe: Daily during run-in period and daily during 12-week randomization treatmentPopulation: 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.
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).
Outcome measures
| Measure |
Symbicort Turbuhaler (Experimental)
n=621 Participants
Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
|
Oxis Turbuhaler (Active Comparator)
n=634 Participants
Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
|
|---|---|---|
|
St George's Respiratory Questionnaire (SGRQ) Total Score
|
-4.37 units on a scale
Standard Deviation 14.544
|
-2.90 units on a scale
Standard Deviation 13.783
|
Adverse Events
Symbicort Turbuhaler (Experimental)
Oxis Turbuhaler (Active Comparator)
Serious adverse events
| Measure |
Symbicort Turbuhaler (Experimental)
n=636 participants at risk
Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
|
Oxis Turbuhaler (Active Comparator)
n=657 participants at risk
Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATIC NEOPLASM MALIGNANT
|
0.00%
0/636
|
0.15%
1/657
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG NEOPLASM MALIGNANT
|
0.16%
1/636
|
0.00%
0/657
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO LUNG
|
0.00%
0/636
|
0.15%
1/657
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.00%
0/636
|
0.15%
1/657
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.00%
0/636
|
0.15%
1/657
|
|
Cardiac disorders
ANGINA UNSTABLE
|
0.00%
0/636
|
0.15%
1/657
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.16%
1/636
|
0.00%
0/657
|
|
Cardiac disorders
CARDIAC FAILURE CHRONIC
|
0.16%
1/636
|
0.00%
0/657
|
|
Cardiac disorders
CARDIOVASCULAR INSUFFICIENCY
|
0.16%
1/636
|
0.00%
0/657
|
|
Cardiac disorders
CORONARY ARTERY INSUFFICIENCY
|
0.00%
0/636
|
0.15%
1/657
|
|
Cardiac disorders
MYOCARDIAL ISCHAEMIA
|
0.00%
0/636
|
0.15%
1/657
|
|
Nervous system disorders
BRAIN STEM STROKE
|
0.16%
1/636
|
0.00%
0/657
|
|
Nervous system disorders
HYPOXIC-ISCHAEMIC ENCEPHALOPATHY
|
0.16%
1/636
|
0.00%
0/657
|
|
Nervous system disorders
ISCHAEMIC STROKE
|
0.00%
0/636
|
0.15%
1/657
|
|
Eye disorders
AMAUROSIS FUGAX
|
0.16%
1/636
|
0.00%
0/657
|
|
Eye disorders
CATARACT
|
0.16%
1/636
|
0.00%
0/657
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.00%
0/636
|
0.15%
1/657
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.16%
1/636
|
0.00%
0/657
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.16%
1/636
|
0.00%
0/657
|
|
General disorders
DEATH
|
0.16%
1/636
|
0.00%
0/657
|
|
Vascular disorders
AORTIC ANEURYSM RUPTURE
|
0.00%
0/636
|
0.15%
1/657
|
|
Investigations
COMPUTERISED TOMOGRAM THORAX ABNORMAL
|
0.16%
1/636
|
0.00%
0/657
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
3.8%
24/636
|
4.3%
28/657
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.16%
1/636
|
0.30%
2/657
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.16%
1/636
|
0.00%
0/657
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
0.00%
0/636
|
0.15%
1/657
|
|
Respiratory, thoracic and mediastinal disorders
INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE
|
0.16%
1/636
|
0.46%
3/657
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA
|
0.47%
3/636
|
0.15%
1/657
|
|
Infections and infestations
APPENDICITIS
|
0.31%
2/636
|
0.00%
0/657
|
|
Infections and infestations
PNEUMONIA BACTERIAL
|
0.16%
1/636
|
0.15%
1/657
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/636
|
0.15%
1/657
|
|
Infections and infestations
BRONCHOPNEUMONIA
|
0.16%
1/636
|
0.00%
0/657
|
|
Infections and infestations
POSTOPERATIVE ABSCESS
|
0.16%
1/636
|
0.00%
0/657
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/636
|
0.15%
1/657
|
|
Gastrointestinal disorders
COLITIS ISCHAEMIC
|
0.00%
0/636
|
0.15%
1/657
|
|
Gastrointestinal disorders
DIVERTICULUM INTESTINAL HAEMORRHAGIC
|
0.00%
0/636
|
0.15%
1/657
|
|
Gastrointestinal disorders
ILEUS
|
0.16%
1/636
|
0.00%
0/657
|
|
Gastrointestinal disorders
PANCREATIC MASS
|
0.00%
0/636
|
0.15%
1/657
|
|
Gastrointestinal disorders
PERITONITIS
|
0.16%
1/636
|
0.00%
0/657
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON CANCER
|
0.16%
1/636
|
0.15%
1/657
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GASTRIC CANCER
|
0.00%
0/636
|
0.15%
1/657
|
Other adverse events
| Measure |
Symbicort Turbuhaler (Experimental)
n=636 participants at risk
Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
|
Oxis Turbuhaler (Active Comparator)
n=657 participants at risk
Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
5.5%
35/636
|
4.9%
32/657
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
4.6%
29/636
|
5.5%
36/657
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER