Trial Outcomes & Findings for A Comparison of SYMBICORT® pMDI With Formoterol Turbuhaler® in Subjects With COPD (NCT NCT00419744)
NCT ID: NCT00419744
Last Updated: 2010-09-16
Results Overview
Rate of exacerbations per subject-year
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1200 participants
Primary outcome timeframe
12 months
Results posted on
2010-09-16
Participant Flow
First patient randomized on 02 January 2007. The last patient completed study on 27 August 2009. The study randomized patients in the United States and Mexico (93 investigational sites), South America (48 investigational sites), and South Africa (20 investigational sites).
The study consisted of an initial screening visit (Visit 1) and 2-week run-in enrollment visits (Visits 2 and 3) prior to being randomized to 1 of 3 treatment groups
Participant milestones
| Measure |
SYM 160/4.5 X 2 BID
SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
|
SYM 80/4.5 X 2 BID
SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
|
FOR 4.5 X 2 BID
Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
|
|---|---|---|---|
|
Overall Study
STARTED
|
407
|
408
|
404
|
|
Overall Study
COMPLETED
|
290
|
290
|
271
|
|
Overall Study
NOT COMPLETED
|
117
|
118
|
133
|
Reasons for withdrawal
| Measure |
SYM 160/4.5 X 2 BID
SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
|
SYM 80/4.5 X 2 BID
SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
|
FOR 4.5 X 2 BID
Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
39
|
40
|
50
|
|
Overall Study
Withdrawal by Subject
|
45
|
49
|
52
|
|
Overall Study
Lost to Follow-up
|
8
|
10
|
6
|
|
Overall Study
Protocol Violation
|
4
|
7
|
8
|
|
Overall Study
Randomized in error
|
9
|
6
|
7
|
|
Overall Study
Moving out of state
|
2
|
0
|
1
|
|
Overall Study
Physician Decision
|
10
|
5
|
6
|
|
Overall Study
Spirometry mouthpiece issues
|
0
|
1
|
2
|
|
Overall Study
Incorrect medication kit dispensed
|
0
|
0
|
1
|
Baseline Characteristics
A Comparison of SYMBICORT® pMDI With Formoterol Turbuhaler® in Subjects With COPD
Baseline characteristics by cohort
| Measure |
SYM 160/4.5 X 2 BID
n=407 Participants
SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
|
SYM 80/4.5 X 2 BID
n=408 Participants
SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
|
FOR 4.5 X 2 BID
n=403 Participants
Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
|
Total
n=1218 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
63.8 Years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
62.8 Years
STANDARD_DEVIATION 9.22 • n=7 Participants
|
62.5 Years
STANDARD_DEVIATION 9.36 • n=5 Participants
|
63.0 Years
STANDARD_DEVIATION 9.34 • n=4 Participants
|
|
Sex: Female, Male
Female
|
145 Participants
n=5 Participants
|
144 Participants
n=7 Participants
|
174 Participants
n=5 Participants
|
463 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
262 Participants
n=5 Participants
|
264 Participants
n=7 Participants
|
229 Participants
n=5 Participants
|
755 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 monthsNumber of COPD-related exacerbations per patient-treatment year. COPD-related exacerbation was defined as worsening COPD that required a course of oral steriods for treatment and/or hospitalization.
Outcome measures
| Measure |
SYM 160/4.5 X 2 BID
n=404 Participants
SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
|
SYM 80/4.5 X 2 BID
n=403 Participants
SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
|
FOR 4.5 X 2 BID
n=403 Participants
Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
|
|---|---|---|---|
|
Total Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient-treatment Year
|
0.75 Exacerbations
|
0.84 Exacerbations
|
1.14 Exacerbations
|
PRIMARY outcome
Timeframe: 12 monthsRate of exacerbations per subject-year
Outcome measures
| Measure |
SYM 160/4.5 X 2 BID
n=404 Participants
SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
|
SYM 80/4.5 X 2 BID
n=403 Participants
SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
|
FOR 4.5 X 2 BID
n=403 Participants
Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
|
|---|---|---|---|
|
Rate of Exacerbations Per Subject-year
|
0.639 Rate
|
0.745 Rate
|
1.029 Rate
|
SECONDARY outcome
Timeframe: 12 monthsChange in pre-dose FEV1 from baseline to the average of the randomized treatment period, as calculated by averaging treatment period FEV1 values and subtracting the pre-dose value.
Outcome measures
| Measure |
SYM 160/4.5 X 2 BID
n=399 Participants
SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
|
SYM 80/4.5 X 2 BID
n=399 Participants
SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
|
FOR 4.5 X 2 BID
n=399 Participants
Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
|
|---|---|---|---|
|
Pre-dose Forced Expiratory Volume in 1 Second (FEV1)
|
0.07 Liters (L)
Standard Deviation 0.18
|
0.07 Liters (L)
Standard Deviation 0.17
|
0.04 Liters (L)
Standard Deviation 0.17
|
SECONDARY outcome
Timeframe: 12 monthsChange in morning PEF from baseline to the average of the randomized treatment period, as calculated by averaging treatment period PEF values and subtracting the baseline morning PEF value.
Outcome measures
| Measure |
SYM 160/4.5 X 2 BID
n=399 Participants
SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
|
SYM 80/4.5 X 2 BID
n=397 Participants
SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
|
FOR 4.5 X 2 BID
n=389 Participants
Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
|
|---|---|---|---|
|
Morning Peak Expiratory Flow (PEF)
|
19.82 L/min
Standard Deviation 37.96
|
19.61 L/min
Standard Deviation 38.83
|
15.81 L/min
Standard Deviation 41.43
|
SECONDARY outcome
Timeframe: 12 monthsChange in evening PEF from baseline to the average of the randomized treatment period, as calculated by averaging treatment period PEF values and subtracting the baseline evening PEF value.
Outcome measures
| Measure |
SYM 160/4.5 X 2 BID
n=400 Participants
SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
|
SYM 80/4.5 X 2 BID
n=397 Participants
SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
|
FOR 4.5 X 2 BID
n=393 Participants
Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
|
|---|---|---|---|
|
Evening PEF
|
17.62 L/min
Standard Deviation 37.86
|
17.77 L/min
Standard Deviation 37.67
|
14.08 L/min
Standard Deviation 41.13
|
SECONDARY outcome
Timeframe: 12 monthsChange from baseline of Dyspnea symptoms evaluated using the breathlessness diary, a 5-point Likert-type scale, ranging from 0 to 4 with higher scores indicating a more severe manifestation of the Dyspnea symptom. Change from baseline was calculated by averaging treatment period Dyspnea scores and subtracting the baseline Dyspnea scores.
Outcome measures
| Measure |
SYM 160/4.5 X 2 BID
n=401 Participants
SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
|
SYM 80/4.5 X 2 BID
n=400 Participants
SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
|
FOR 4.5 X 2 BID
n=398 Participants
Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
|
|---|---|---|---|
|
Dyspnea Symptom Scores
|
-0.30 Scores on a scale
Standard Deviation 0.65
|
-0.29 Scores on a scale
Standard Deviation 0.70
|
-0.24 Scores on a scale
Standard Deviation 0.67
|
SECONDARY outcome
Timeframe: 12 monthsChange from baseline in the use of beta-2 agonists, as calculated by averaging treatment period inhalations per day and subtracting the baseline number of inhalations per day.
Outcome measures
| Measure |
SYM 160/4.5 X 2 BID
n=401 Participants
SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
|
SYM 80/4.5 X 2 BID
n=401 Participants
SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
|
FOR 4.5 X 2 BID
n=399 Participants
Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
|
|---|---|---|---|
|
Use of Rescue Medication
|
-1.21 Number of inhalations
Standard Deviation 3.57
|
-1.03 Number of inhalations
Standard Deviation 3.74
|
-0.28 Number of inhalations
Standard Deviation 3.60
|
SECONDARY outcome
Timeframe: 12 monthsChange from baseline in the SGRQ overall score, as calculated by averaging treatment period SGRQ scores and subtracting the baseline SGRQ scores. The SGRQ contains 3 domains: Symptoms (distress due to respiratory symptoms, 8 questions), Activity (disturbance of physical activity, 16 questions), and Impacts (overall impact on daily life and well-being, 26 questions). Lower scores are associated with less severe symptoms.
Outcome measures
| Measure |
SYM 160/4.5 X 2 BID
n=375 Participants
SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
|
SYM 80/4.5 X 2 BID
n=366 Participants
SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
|
FOR 4.5 X 2 BID
n=357 Participants
Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
|
|---|---|---|---|
|
St. George's Respiratory Questionnaire (SGRQ) Score
|
-6.23 Scores on a scale
Standard Deviation 14.72
|
-5.00 Scores on a scale
Standard Deviation 16.10
|
-5.71 Scores on a scale
Standard Deviation 15.31
|
Adverse Events
SYM 160/4.5 X 2 BID
Serious events: 79 serious events
Other events: 193 other events
Deaths: 0 deaths
SYM 80/4.5 X 2 BID
Serious events: 61 serious events
Other events: 177 other events
Deaths: 0 deaths
FOR 4.5 X 2 BID
Serious events: 73 serious events
Other events: 176 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SYM 160/4.5 X 2 BID
n=407 participants at risk
SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
|
SYM 80/4.5 X 2 BID
n=408 participants at risk
SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
|
FOR 4.5 X 2 BID
n=403 participants at risk
Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.49%
2/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Cardiac disorders
Atrial Fibrillation
|
1.5%
6/407 • 12 months
|
0.74%
3/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/407 • 12 months
|
0.25%
1/408 • 12 months
|
0.74%
3/403 • 12 months
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.74%
3/407 • 12 months
|
0.25%
1/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/407 • 12 months
|
0.25%
1/408 • 12 months
|
0.50%
2/403 • 12 months
|
|
Cardiac disorders
Cor Pulmonale
|
0.00%
0/407 • 12 months
|
0.25%
1/408 • 12 months
|
0.50%
2/403 • 12 months
|
|
Cardiac disorders
Cardiac Failure Acute
|
0.49%
2/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.25%
1/407 • 12 months
|
0.49%
2/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Cardiac disorders
Angina Pectoris
|
0.25%
1/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.25%
1/403 • 12 months
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.25%
1/403 • 12 months
|
|
Cardiac disorders
Angina Unstable
|
0.25%
1/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Cardiac disorders
Cardiac Failure
|
0.25%
1/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.25%
1/407 • 12 months
|
0.25%
1/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.00%
0/407 • 12 months
|
0.25%
1/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Cardiac disorders
Aortic Valve Stenosis
|
0.00%
0/407 • 12 months
|
0.25%
1/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Cardiac disorders
Atrial Tachycardia
|
0.00%
0/407 • 12 months
|
0.25%
1/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Cardiac disorders
Right Ventricular Failure
|
0.00%
0/407 • 12 months
|
0.25%
1/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.50%
2/403 • 12 months
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.49%
2/407 • 12 months
|
0.25%
1/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.49%
2/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.25%
1/403 • 12 months
|
|
Gastrointestinal disorders
Food Poisoning
|
0.00%
0/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.25%
1/403 • 12 months
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
0.00%
0/407 • 12 months
|
0.25%
1/408 • 12 months
|
0.25%
1/403 • 12 months
|
|
Gastrointestinal disorders
Abdominal Hernia Obstructive
|
0.25%
1/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.25%
1/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Gastrointestinal disorders
Gastritis Haemorrhagic
|
0.00%
0/407 • 12 months
|
0.25%
1/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Gastrointestinal disorders
Gastroduodenal Ulcer
|
0.00%
0/407 • 12 months
|
0.25%
1/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/407 • 12 months
|
0.25%
1/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Gastrointestinal disorders
Pancreatitis Chronic
|
0.00%
0/407 • 12 months
|
0.25%
1/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.00%
0/407 • 12 months
|
0.25%
1/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
General disorders
Non-Cardiac Chest Pain
|
0.49%
2/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.25%
1/403 • 12 months
|
|
General disorders
Death
|
0.25%
1/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
General disorders
Multi-Organ Failure
|
0.00%
0/407 • 12 months
|
0.25%
1/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
General disorders
Sudden Death
|
0.00%
0/407 • 12 months
|
0.25%
1/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/407 • 12 months
|
0.49%
2/408 • 12 months
|
0.25%
1/403 • 12 months
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.25%
1/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/407 • 12 months
|
0.25%
1/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Hepatobiliary disorders
Jaundice Cholestatic
|
0.00%
0/407 • 12 months
|
0.25%
1/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Infections and infestations
Pneumonia Bacterial
|
3.2%
13/407 • 12 months
|
0.98%
4/408 • 12 months
|
1.7%
7/403 • 12 months
|
|
Infections and infestations
Bronchitis
|
0.00%
0/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.74%
3/403 • 12 months
|
|
Infections and infestations
Upper Respiratory Tract Infection Bacterial
|
0.00%
0/407 • 12 months
|
0.49%
2/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Infections and infestations
Appendicitis
|
0.00%
0/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.25%
1/403 • 12 months
|
|
Infections and infestations
Bronchitis Bacterial
|
0.25%
1/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.25%
1/403 • 12 months
|
|
Infections and infestations
Dengue Fever
|
0.00%
0/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.25%
1/403 • 12 months
|
|
Infections and infestations
Enterocolitis Bacterial
|
0.00%
0/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.25%
1/403 • 12 months
|
|
Infections and infestations
Lobar Pneumonia
|
0.00%
0/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.25%
1/403 • 12 months
|
|
Infections and infestations
Pneumonia Viral
|
0.25%
1/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.25%
1/403 • 12 months
|
|
Infections and infestations
Sinusitis
|
0.00%
0/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.25%
1/403 • 12 months
|
|
Infections and infestations
Cellulitis
|
0.25%
1/407 • 12 months
|
0.25%
1/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Infections and infestations
Hepatitis A
|
0.25%
1/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.25%
1/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Infections and infestations
Lower Respiratory Tract Infection Bacterial
|
0.25%
1/407 • 12 months
|
0.25%
1/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Infections and infestations
Pneumonia
|
0.25%
1/407 • 12 months
|
0.25%
1/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Infections and infestations
Anal Abscess
|
0.00%
0/407 • 12 months
|
0.25%
1/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Infections and infestations
Gangrene
|
0.00%
0/407 • 12 months
|
0.25%
1/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Infections and infestations
Pneumonia Staphylococcal
|
0.00%
0/407 • 12 months
|
0.25%
1/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Infections and infestations
Septic Shock
|
0.00%
0/407 • 12 months
|
0.25%
1/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
0.00%
0/407 • 12 months
|
0.25%
1/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.25%
1/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.25%
1/403 • 12 months
|
|
Injury, poisoning and procedural complications
Drug Toxicity
|
0.00%
0/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.25%
1/403 • 12 months
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.00%
0/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.25%
1/403 • 12 months
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
0.00%
0/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.25%
1/403 • 12 months
|
|
Injury, poisoning and procedural complications
Collapse Of Lung
|
0.25%
1/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.25%
1/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.25%
1/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Injury, poisoning and procedural complications
Overdose
|
0.25%
1/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Injury, poisoning and procedural complications
Dislocation Of Joint Prosthesis
|
0.00%
0/407 • 12 months
|
0.25%
1/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.00%
0/407 • 12 months
|
0.25%
1/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/407 • 12 months
|
0.25%
1/408 • 12 months
|
0.25%
1/403 • 12 months
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.25%
1/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/407 • 12 months
|
0.25%
1/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/407 • 12 months
|
0.25%
1/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis Pyrophosphate
|
0.00%
0/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.25%
1/403 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Foot Fracture
|
0.25%
1/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.25%
1/403 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.25%
1/403 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Adenocarcinoma
|
0.00%
0/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.25%
1/403 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Bronchial Carcinoma
|
0.00%
0/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.25%
1/403 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Small Cell Lung Cancer Stage Iii
|
0.00%
0/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.25%
1/403 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal Adenocarcinoma
|
0.00%
0/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.25%
1/403 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal Squamous Cell Carcinoma
|
0.00%
0/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.25%
1/403 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
0.00%
0/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.25%
1/403 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.25%
1/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer
|
0.25%
1/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Cancer
|
0.25%
1/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma Malignant
|
0.25%
1/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Neoplasm
|
0.25%
1/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Small Cell Lung Cancer
|
0.25%
1/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid Adenoma
|
0.25%
1/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm
|
0.00%
0/407 • 12 months
|
0.25%
1/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.49%
2/407 • 12 months
|
0.25%
1/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Nervous system disorders
Convulsion
|
0.00%
0/407 • 12 months
|
0.25%
1/408 • 12 months
|
0.25%
1/403 • 12 months
|
|
Nervous system disorders
Syncope
|
0.00%
0/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.25%
1/403 • 12 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.25%
1/403 • 12 months
|
|
Psychiatric disorders
Anxiety Disorder
|
0.25%
1/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Psychiatric disorders
Psychotic Disorder
|
0.00%
0/407 • 12 months
|
0.25%
1/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Renal and urinary disorders
Urethral Stenosis
|
0.00%
0/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.25%
1/403 • 12 months
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.25%
1/403 • 12 months
|
|
Renal and urinary disorders
Renal Aneurysm
|
0.25%
1/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Renal and urinary disorders
Calculus Ureteric
|
0.00%
0/407 • 12 months
|
0.25%
1/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/407 • 12 months
|
0.25%
1/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/407 • 12 months
|
0.25%
1/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Renal and urinary disorders
Renal Mass
|
0.00%
0/407 • 12 months
|
0.25%
1/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.25%
1/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.25%
1/403 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
7.9%
32/407 • 12 months
|
8.1%
33/408 • 12 months
|
8.4%
34/403 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.74%
3/407 • 12 months
|
0.49%
2/408 • 12 months
|
0.25%
1/403 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.49%
2/407 • 12 months
|
0.25%
1/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.49%
2/407 • 12 months
|
0.49%
2/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.25%
1/403 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.25%
1/403 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.25%
1/403 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Mass
|
0.00%
0/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.25%
1/403 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial Secretion Retention
|
0.25%
1/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Disorder
|
0.00%
0/407 • 12 months
|
0.25%
1/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/407 • 12 months
|
0.25%
1/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Skin and subcutaneous tissue disorders
Decubitus Ulcer
|
0.00%
0/407 • 12 months
|
0.25%
1/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Vascular disorders
Accelerated Hypertension
|
0.00%
0/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.25%
1/403 • 12 months
|
|
Vascular disorders
Arterial Thrombosis Limb
|
0.00%
0/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.25%
1/403 • 12 months
|
|
Vascular disorders
Hypertensive Crisis
|
0.00%
0/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.25%
1/403 • 12 months
|
|
Vascular disorders
Iliac Artery Occlusion
|
0.00%
0/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.25%
1/403 • 12 months
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
0.00%
0/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.25%
1/403 • 12 months
|
|
Vascular disorders
Haematoma
|
0.25%
1/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Vascular disorders
Hypotension
|
0.25%
1/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Vascular disorders
Thrombosis
|
0.25%
1/407 • 12 months
|
0.00%
0/408 • 12 months
|
0.00%
0/403 • 12 months
|
|
Vascular disorders
Intermittent Claudication
|
0.00%
0/407 • 12 months
|
0.25%
1/408 • 12 months
|
0.00%
0/403 • 12 months
|
Other adverse events
| Measure |
SYM 160/4.5 X 2 BID
n=407 participants at risk
SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
|
SYM 80/4.5 X 2 BID
n=408 participants at risk
SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
|
FOR 4.5 X 2 BID
n=403 participants at risk
Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
7.6%
31/407 • 12 months
|
8.6%
35/408 • 12 months
|
10.2%
41/403 • 12 months
|
|
Infections and infestations
Bronchitis
|
9.1%
37/407 • 12 months
|
7.8%
32/408 • 12 months
|
6.2%
25/403 • 12 months
|
|
Infections and infestations
Influenza
|
7.1%
29/407 • 12 months
|
6.4%
26/408 • 12 months
|
6.2%
25/403 • 12 months
|
|
Infections and infestations
Upper Respiratory Tract Infection Bacterial
|
4.4%
18/407 • 12 months
|
5.6%
23/408 • 12 months
|
4.2%
17/403 • 12 months
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
5.2%
21/407 • 12 months
|
3.2%
13/408 • 12 months
|
3.5%
14/403 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.2%
21/407 • 12 months
|
4.4%
18/408 • 12 months
|
5.2%
21/403 • 12 months
|
|
Nervous system disorders
Headache
|
13.8%
56/407 • 12 months
|
11.3%
46/408 • 12 months
|
10.7%
43/403 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
14.0%
57/407 • 12 months
|
11.3%
46/408 • 12 months
|
16.9%
68/403 • 12 months
|
|
Vascular disorders
Hypertension
|
5.2%
21/407 • 12 months
|
3.9%
16/408 • 12 months
|
2.2%
9/403 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI may use the Multi-Center Study Results and the Site Data for the limited purpose of his or her own research and academic analysis until the earlier of the publication of the first Multi-center Publication and the second anniversary of the completion of the Multi-center Study at all participating sites.
- Publication restrictions are in place
Restriction type: OTHER