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A Comparison of SYMBICORT® pMDI With Formoterol Turbuhaler® in Subjects With COPD

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ClinicalTrials.gov Identifier: NCT00419744
Recruitment Status : Completed
First Posted : January 9, 2007
Results First Posted : September 16, 2010
Last Update Posted : September 16, 2010
Sponsor:
Information provided by:
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition Chronic Obstructive Pulmonary Disease
Interventions Drug: Budesonide/formoterol (SYMBICORT) pMDI
Drug: Formoterol Turbuhaler
Enrollment 1200
Recruitment Details 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).
Pre-assignment Details 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
Arm/Group Title SYM 160/4.5 X 2 BID SYM 80/4.5 X 2 BID FOR 4.5 X 2 BID
Hide Arm/Group Description SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID) SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
Period Title: Overall Study
Started 407 408 404
Completed 290 290 271
Not Completed 117 118 133
Reason Not Completed
Adverse Event             39             40             50
Withdrawal by Subject             45             49             52
Lost to Follow-up             8             10             6
Protocol Violation             4             7             8
Randomized in error             9             6             7
Moving out of state             2             0             1
Physician Decision             10             5             6
Spirometry mouthpiece issues             0             1             2
Incorrect medication kit dispensed             0             0             1
Arm/Group Title SYM 160/4.5 X 2 BID SYM 80/4.5 X 2 BID FOR 4.5 X 2 BID Total
Hide Arm/Group Description SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID) SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID Formoterol Turbuhaler 4.5 μg x 2 inhalations BID Total of all reporting groups
Overall Number of Baseline Participants 407 408 403 1218
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 407 participants 408 participants 403 participants 1218 participants
63.8  (9.4) 62.8  (9.22) 62.5  (9.36) 63.0  (9.34)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 407 participants 408 participants 403 participants 1218 participants
Female
145
  35.6%
144
  35.3%
174
  43.2%
463
  38.0%
Male
262
  64.4%
264
  64.7%
229
  56.8%
755
  62.0%
1.Primary Outcome
Title Total Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient-treatment Year
Hide Description Number 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.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SYM 160/4.5 X 2 BID SYM 80/4.5 X 2 BID FOR 4.5 X 2 BID
Hide Arm/Group Description:
SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
Overall Number of Participants Analyzed 404 403 403
Measure Type: Number
Unit of Measure: Exacerbations
0.75 0.84 1.14
2.Primary Outcome
Title Rate of Exacerbations Per Subject-year
Hide Description Rate of exacerbations per subject-year
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SYM 160/4.5 X 2 BID SYM 80/4.5 X 2 BID FOR 4.5 X 2 BID
Hide Arm/Group Description:
SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
Overall Number of Participants Analyzed 404 403 403
Measure Type: Number
Unit of Measure: Rate
0.639 0.745 1.029
3.Secondary Outcome
Title Pre-dose Forced Expiratory Volume in 1 Second (FEV1)
Hide Description Change 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.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SYM 160/4.5 X 2 BID SYM 80/4.5 X 2 BID FOR 4.5 X 2 BID
Hide Arm/Group Description:
SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
Overall Number of Participants Analyzed 399 399 399
Mean (Standard Deviation)
Unit of Measure: Liters (L)
0.07  (0.18) 0.07  (0.17) 0.04  (0.17)
4.Secondary Outcome
Title Morning Peak Expiratory Flow (PEF)
Hide Description Change 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.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SYM 160/4.5 X 2 BID SYM 80/4.5 X 2 BID FOR 4.5 X 2 BID
Hide Arm/Group Description:
SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
Overall Number of Participants Analyzed 399 397 389
Mean (Standard Deviation)
Unit of Measure: L/min
19.82  (37.96) 19.61  (38.83) 15.81  (41.43)
5.Secondary Outcome
Title Evening PEF
Hide Description Change 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.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SYM 160/4.5 X 2 BID SYM 80/4.5 X 2 BID FOR 4.5 X 2 BID
Hide Arm/Group Description:
SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
Overall Number of Participants Analyzed 400 397 393
Mean (Standard Deviation)
Unit of Measure: L/min
17.62  (37.86) 17.77  (37.67) 14.08  (41.13)
6.Secondary Outcome
Title Dyspnea Symptom Scores
Hide Description Change 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.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SYM 160/4.5 X 2 BID SYM 80/4.5 X 2 BID FOR 4.5 X 2 BID
Hide Arm/Group Description:
SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
Overall Number of Participants Analyzed 401 400 398
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.30  (0.65) -0.29  (0.70) -0.24  (0.67)
7.Secondary Outcome
Title Use of Rescue Medication
Hide Description Change 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.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SYM 160/4.5 X 2 BID SYM 80/4.5 X 2 BID FOR 4.5 X 2 BID
Hide Arm/Group Description:
SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
Overall Number of Participants Analyzed 401 401 399
Mean (Standard Deviation)
Unit of Measure: Number of inhalations
-1.21  (3.57) -1.03  (3.74) -0.28  (3.60)
8.Secondary Outcome
Title St. George's Respiratory Questionnaire (SGRQ) Score
Hide Description Change 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.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SYM 160/4.5 X 2 BID SYM 80/4.5 X 2 BID FOR 4.5 X 2 BID
Hide Arm/Group Description:
SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
Overall Number of Participants Analyzed 375 366 357
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-6.23  (14.72) -5.00  (16.10) -5.71  (15.31)
Time Frame 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SYM 160/4.5 X 2 BID SYM 80/4.5 X 2 BID FOR 4.5 X 2 BID
Hide Arm/Group Description SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID) SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
All-Cause Mortality
SYM 160/4.5 X 2 BID SYM 80/4.5 X 2 BID FOR 4.5 X 2 BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
SYM 160/4.5 X 2 BID SYM 80/4.5 X 2 BID FOR 4.5 X 2 BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   79/407 (19.41%)   61/408 (14.95%)   73/403 (18.11%) 
Blood and lymphatic system disorders       
Anaemia  1  2/407 (0.49%)  0/408 (0.00%)  0/403 (0.00%) 
Cardiac disorders       
Atrial Fibrillation  1  6/407 (1.47%)  3/408 (0.74%)  0/403 (0.00%) 
Myocardial Infarction  1  0/407 (0.00%)  1/408 (0.25%)  3/403 (0.74%) 
Cardiac Failure Congestive  1  3/407 (0.74%)  1/408 (0.25%)  0/403 (0.00%) 
Cardiac Arrest  1  0/407 (0.00%)  1/408 (0.25%)  2/403 (0.50%) 
Cor Pulmonale  1  0/407 (0.00%)  1/408 (0.25%)  2/403 (0.50%) 
Cardiac Failure Acute  1  2/407 (0.49%)  0/408 (0.00%)  0/403 (0.00%) 
Supraventricular Tachycardia  1  1/407 (0.25%)  2/408 (0.49%)  0/403 (0.00%) 
Angina Pectoris  1  1/407 (0.25%)  0/408 (0.00%)  1/403 (0.25%) 
Atrial Flutter  1  0/407 (0.00%)  0/408 (0.00%)  1/403 (0.25%) 
Angina Unstable  1  1/407 (0.25%)  0/408 (0.00%)  0/403 (0.00%) 
Cardiac Failure  1  1/407 (0.25%)  0/408 (0.00%)  0/403 (0.00%) 
Cardio-Respiratory Arrest  1  1/407 (0.25%)  1/408 (0.25%)  0/403 (0.00%) 
Acute Coronary Syndrome  1  0/407 (0.00%)  1/408 (0.25%)  0/403 (0.00%) 
Aortic Valve Stenosis  1  0/407 (0.00%)  1/408 (0.25%)  0/403 (0.00%) 
Atrial Tachycardia  1  0/407 (0.00%)  1/408 (0.25%)  0/403 (0.00%) 
Right Ventricular Failure  1  0/407 (0.00%)  1/408 (0.25%)  0/403 (0.00%) 
Gastrointestinal disorders       
Gastritis  1  0/407 (0.00%)  0/408 (0.00%)  2/403 (0.50%) 
Gastrointestinal Haemorrhage  1  2/407 (0.49%)  1/408 (0.25%)  0/403 (0.00%) 
Intestinal Obstruction  1  2/407 (0.49%)  0/408 (0.00%)  1/403 (0.25%) 
Food Poisoning  1  0/407 (0.00%)  0/408 (0.00%)  1/403 (0.25%) 
Upper Gastrointestinal Haemorrhage  1  0/407 (0.00%)  1/408 (0.25%)  1/403 (0.25%) 
Abdominal Hernia Obstructive  1  1/407 (0.25%)  0/408 (0.00%)  0/403 (0.00%) 
Small Intestinal Obstruction  1  1/407 (0.25%)  0/408 (0.00%)  0/403 (0.00%) 
Gastritis Haemorrhagic  1  0/407 (0.00%)  1/408 (0.25%)  0/403 (0.00%) 
Gastroduodenal Ulcer  1  0/407 (0.00%)  1/408 (0.25%)  0/403 (0.00%) 
Ileus  1  0/407 (0.00%)  1/408 (0.25%)  0/403 (0.00%) 
Pancreatitis Chronic  1  0/407 (0.00%)  1/408 (0.25%)  0/403 (0.00%) 
Rectal Haemorrhage  1  0/407 (0.00%)  1/408 (0.25%)  0/403 (0.00%) 
General disorders       
Non-Cardiac Chest Pain  1  2/407 (0.49%)  0/408 (0.00%)  1/403 (0.25%) 
Death  1  1/407 (0.25%)  0/408 (0.00%)  0/403 (0.00%) 
Multi-Organ Failure  1  0/407 (0.00%)  1/408 (0.25%)  0/403 (0.00%) 
Sudden Death  1  0/407 (0.00%)  1/408 (0.25%)  0/403 (0.00%) 
Hepatobiliary disorders       
Cholecystitis  1  0/407 (0.00%)  2/408 (0.49%)  1/403 (0.25%) 
Cholecystitis Acute  1  1/407 (0.25%)  0/408 (0.00%)  0/403 (0.00%) 
Cholelithiasis  1  0/407 (0.00%)  1/408 (0.25%)  0/403 (0.00%) 
Jaundice Cholestatic  1  0/407 (0.00%)  1/408 (0.25%)  0/403 (0.00%) 
Infections and infestations       
Pneumonia Bacterial  1  13/407 (3.19%)  4/408 (0.98%)  7/403 (1.74%) 
Bronchitis  1  0/407 (0.00%)  0/408 (0.00%)  3/403 (0.74%) 
Upper Respiratory Tract Infection Bacterial  1  0/407 (0.00%)  2/408 (0.49%)  0/403 (0.00%) 
Appendicitis  1  0/407 (0.00%)  0/408 (0.00%)  1/403 (0.25%) 
Bronchitis Bacterial  1  1/407 (0.25%)  0/408 (0.00%)  1/403 (0.25%) 
Dengue Fever  1  0/407 (0.00%)  0/408 (0.00%)  1/403 (0.25%) 
Enterocolitis Bacterial  1  0/407 (0.00%)  0/408 (0.00%)  1/403 (0.25%) 
Lobar Pneumonia  1  0/407 (0.00%)  0/408 (0.00%)  1/403 (0.25%) 
Pneumonia Viral  1  1/407 (0.25%)  0/408 (0.00%)  1/403 (0.25%) 
Sinusitis  1  0/407 (0.00%)  0/408 (0.00%)  1/403 (0.25%) 
Cellulitis  1  1/407 (0.25%)  1/408 (0.25%)  0/403 (0.00%) 
Hepatitis A  1  1/407 (0.25%)  0/408 (0.00%)  0/403 (0.00%) 
Lower Respiratory Tract Infection  1  1/407 (0.25%)  0/408 (0.00%)  0/403 (0.00%) 
Lower Respiratory Tract Infection Bacterial  1  1/407 (0.25%)  1/408 (0.25%)  0/403 (0.00%) 
Pneumonia  1  1/407 (0.25%)  1/408 (0.25%)  0/403 (0.00%) 
Anal Abscess  1  0/407 (0.00%)  1/408 (0.25%)  0/403 (0.00%) 
Gangrene  1  0/407 (0.00%)  1/408 (0.25%)  0/403 (0.00%) 
Pneumonia Staphylococcal  1  0/407 (0.00%)  1/408 (0.25%)  0/403 (0.00%) 
Septic Shock  1  0/407 (0.00%)  1/408 (0.25%)  0/403 (0.00%) 
Viral Upper Respiratory Tract Infection  1  0/407 (0.00%)  1/408 (0.25%)  0/403 (0.00%) 
Injury, poisoning and procedural complications       
Ankle Fracture  1  1/407 (0.25%)  0/408 (0.00%)  1/403 (0.25%) 
Drug Toxicity  1  0/407 (0.00%)  0/408 (0.00%)  1/403 (0.25%) 
Femur Fracture  1  0/407 (0.00%)  0/408 (0.00%)  1/403 (0.25%) 
Subdural Haematoma  1  0/407 (0.00%)  0/408 (0.00%)  1/403 (0.25%) 
Collapse Of Lung  1  1/407 (0.25%)  0/408 (0.00%)  0/403 (0.00%) 
Fall  1  1/407 (0.25%)  0/408 (0.00%)  0/403 (0.00%) 
Hip Fracture  1  1/407 (0.25%)  0/408 (0.00%)  0/403 (0.00%) 
Overdose  1  1/407 (0.25%)  0/408 (0.00%)  0/403 (0.00%) 
Dislocation Of Joint Prosthesis  1  0/407 (0.00%)  1/408 (0.25%)  0/403 (0.00%) 
Rib Fracture  1  0/407 (0.00%)  1/408 (0.25%)  0/403 (0.00%) 
Metabolism and nutrition disorders       
Dehydration  1  0/407 (0.00%)  1/408 (0.25%)  1/403 (0.25%) 
Diabetes Mellitus  1  1/407 (0.25%)  0/408 (0.00%)  0/403 (0.00%) 
Hyperglycaemia  1  0/407 (0.00%)  1/408 (0.25%)  0/403 (0.00%) 
Hyponatraemia  1  0/407 (0.00%)  1/408 (0.25%)  0/403 (0.00%) 
Musculoskeletal and connective tissue disorders       
Chondrocalcinosis Pyrophosphate  1  0/407 (0.00%)  0/408 (0.00%)  1/403 (0.25%) 
Foot Fracture  1  1/407 (0.25%)  0/408 (0.00%)  1/403 (0.25%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Breast Cancer  1  0/407 (0.00%)  0/408 (0.00%)  1/403 (0.25%) 
Lung Adenocarcinoma  1  0/407 (0.00%)  0/408 (0.00%)  1/403 (0.25%) 
Metastatic Bronchial Carcinoma  1  0/407 (0.00%)  0/408 (0.00%)  1/403 (0.25%) 
Non-Small Cell Lung Cancer Stage Iii  1  0/407 (0.00%)  0/408 (0.00%)  1/403 (0.25%) 
Oesophageal Adenocarcinoma  1  0/407 (0.00%)  0/408 (0.00%)  1/403 (0.25%) 
Oesophageal Squamous Cell Carcinoma  1  0/407 (0.00%)  0/408 (0.00%)  1/403 (0.25%) 
Squamous Cell Carcinoma  1  0/407 (0.00%)  0/408 (0.00%)  1/403 (0.25%) 
Adenocarcinoma  1  1/407 (0.25%)  0/408 (0.00%)  0/403 (0.00%) 
Bladder Cancer  1  1/407 (0.25%)  0/408 (0.00%)  0/403 (0.00%) 
Gastric Cancer  1  1/407 (0.25%)  0/408 (0.00%)  0/403 (0.00%) 
Mesothelioma Malignant  1  1/407 (0.25%)  0/408 (0.00%)  0/403 (0.00%) 
Metastatic Neoplasm  1  1/407 (0.25%)  0/408 (0.00%)  0/403 (0.00%) 
Non-Small Cell Lung Cancer  1  1/407 (0.25%)  0/408 (0.00%)  0/403 (0.00%) 
Thyroid Adenoma  1  1/407 (0.25%)  0/408 (0.00%)  0/403 (0.00%) 
Lung Neoplasm  1  0/407 (0.00%)  1/408 (0.25%)  0/403 (0.00%) 
Nervous system disorders       
Cerebrovascular Accident  1  2/407 (0.49%)  1/408 (0.25%)  0/403 (0.00%) 
Convulsion  1  0/407 (0.00%)  1/408 (0.25%)  1/403 (0.25%) 
Syncope  1  0/407 (0.00%)  0/408 (0.00%)  1/403 (0.25%) 
Psychiatric disorders       
Depression  1  0/407 (0.00%)  0/408 (0.00%)  1/403 (0.25%) 
Anxiety Disorder  1  1/407 (0.25%)  0/408 (0.00%)  0/403 (0.00%) 
Psychotic Disorder  1  0/407 (0.00%)  1/408 (0.25%)  0/403 (0.00%) 
Renal and urinary disorders       
Urethral Stenosis  1  0/407 (0.00%)  0/408 (0.00%)  1/403 (0.25%) 
Urinary Retention  1  0/407 (0.00%)  0/408 (0.00%)  1/403 (0.25%) 
Renal Aneurysm  1  1/407 (0.25%)  0/408 (0.00%)  0/403 (0.00%) 
Calculus Ureteric  1  0/407 (0.00%)  1/408 (0.25%)  0/403 (0.00%) 
Haematuria  1  0/407 (0.00%)  1/408 (0.25%)  0/403 (0.00%) 
Nephrolithiasis  1  0/407 (0.00%)  1/408 (0.25%)  0/403 (0.00%) 
Renal Mass  1  0/407 (0.00%)  1/408 (0.25%)  0/403 (0.00%) 
Reproductive system and breast disorders       
Benign Prostatic Hyperplasia  1  1/407 (0.25%)  0/408 (0.00%)  1/403 (0.25%) 
Respiratory, thoracic and mediastinal disorders       
Chronic Obstructive Pulmonary Disease  1  32/407 (7.86%)  33/408 (8.09%)  34/403 (8.44%) 
Respiratory Failure  1  3/407 (0.74%)  2/408 (0.49%)  1/403 (0.25%) 
Acute Respiratory Failure  1  2/407 (0.49%)  1/408 (0.25%)  0/403 (0.00%) 
Pneumothorax  1  2/407 (0.49%)  2/408 (0.49%)  0/403 (0.00%) 
Dyspnoea  1  0/407 (0.00%)  0/408 (0.00%)  1/403 (0.25%) 
Pneumonitis  1  0/407 (0.00%)  0/408 (0.00%)  1/403 (0.25%) 
Pulmonary Embolism  1  0/407 (0.00%)  0/408 (0.00%)  1/403 (0.25%) 
Pulmonary Mass  1  0/407 (0.00%)  0/408 (0.00%)  1/403 (0.25%) 
Bronchial Secretion Retention  1  1/407 (0.25%)  0/408 (0.00%)  0/403 (0.00%) 
Laryngeal Disorder  1  0/407 (0.00%)  1/408 (0.25%)  0/403 (0.00%) 
Pleural Effusion  1  0/407 (0.00%)  1/408 (0.25%)  0/403 (0.00%) 
Skin and subcutaneous tissue disorders       
Decubitus Ulcer  1  0/407 (0.00%)  1/408 (0.25%)  0/403 (0.00%) 
Vascular disorders       
Accelerated Hypertension  1  0/407 (0.00%)  0/408 (0.00%)  1/403 (0.25%) 
Arterial Thrombosis Limb  1  0/407 (0.00%)  0/408 (0.00%)  1/403 (0.25%) 
Hypertensive Crisis  1  0/407 (0.00%)  0/408 (0.00%)  1/403 (0.25%) 
Iliac Artery Occlusion  1  0/407 (0.00%)  0/408 (0.00%)  1/403 (0.25%) 
Peripheral Arterial Occlusive Disease  1  0/407 (0.00%)  0/408 (0.00%)  1/403 (0.25%) 
Haematoma  1  1/407 (0.25%)  0/408 (0.00%)  0/403 (0.00%) 
Hypotension  1  1/407 (0.25%)  0/408 (0.00%)  0/403 (0.00%) 
Thrombosis  1  1/407 (0.25%)  0/408 (0.00%)  0/403 (0.00%) 
Intermittent Claudication  1  0/407 (0.00%)  1/408 (0.25%)  0/403 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SYM 160/4.5 X 2 BID SYM 80/4.5 X 2 BID FOR 4.5 X 2 BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   193/407 (47.42%)   177/408 (43.38%)   176/403 (43.67%) 
Infections and infestations       
Nasopharyngitis  1  31/407 (7.62%)  35/408 (8.58%)  41/403 (10.17%) 
Bronchitis  1  37/407 (9.09%)  32/408 (7.84%)  25/403 (6.20%) 
Influenza  1  29/407 (7.13%)  26/408 (6.37%)  25/403 (6.20%) 
Upper Respiratory Tract Infection Bacterial  1  18/407 (4.42%)  23/408 (5.64%)  17/403 (4.22%) 
Viral Upper Respiratory Tract Infection  1  21/407 (5.16%)  13/408 (3.19%)  14/403 (3.47%) 
Musculoskeletal and connective tissue disorders       
Back Pain  1  21/407 (5.16%)  18/408 (4.41%)  21/403 (5.21%) 
Nervous system disorders       
Headache  1  56/407 (13.76%)  46/408 (11.27%)  43/403 (10.67%) 
Respiratory, thoracic and mediastinal disorders       
Chronic Obstructive Pulmonary Disease  1  57/407 (14.00%)  46/408 (11.27%)  68/403 (16.87%) 
Vascular disorders       
Hypertension  1  21/407 (5.16%)  16/408 (3.92%)  9/403 (2.23%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
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.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gerard Lynch
Organization: AstraZeneca
EMail: aztrial_results_posting@astrazeneca.com
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00419744     History of Changes
Other Study ID Numbers: D589CC00003
First Submitted: January 5, 2007
First Posted: January 9, 2007
Results First Submitted: August 18, 2010
Results First Posted: September 16, 2010
Last Update Posted: September 16, 2010