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Trial record 17 of 183 for:    Foradil Combi OR symbicort OR (Budesonide AND formeterol)

A 6 Month Safety Study Comparing Symbicort With Inhaled Corticosteroid Only in Asthmatic Adults and Adolescents

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ClinicalTrials.gov Identifier: NCT01444430
Recruitment Status : Completed
First Posted : September 30, 2011
Results First Posted : December 15, 2016
Last Update Posted : December 15, 2016
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 Asthma
Interventions Drug: Symbicort pMDI
Drug: budesonide pMDI
Enrollment 12460
Recruitment Details This study started with an assessment visit where inclusion/exclusion criteria were reviewed and informed consent obtained. Eligible patients were randomized at the next visit. Patients then entered a 26 weeks double-blind treatment period followed by a 1 week follow-up telephone contact. Patients were recruited in 25 countries with 25% in the US.
Pre-assignment Details Eligible adult and adolescent patients were stratified based upon assessment of ACQ and prior asthma therapy and randomized 1:1 to double-blind Symbicort or budesonide. 12460 patients were enrolled (informed consent received) and 11693 were randomized.
Arm/Group Title Symbicort Budesonide
Hide Arm/Group Description Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening). Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
Period Title: Overall Study
Started 5846 5847
Completed 5785 5766
Not Completed 61 81
Reason Not Completed
Withdrawal by Subject             53             72
Death             6             8
Lost to Follow-up             2             0
CRF termination module not completed.             0             1
Arm/Group Title Symbicort Budesonide Total
Hide Arm/Group Description Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening). Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening). Total of all reporting groups
Overall Number of Baseline Participants 5846 5847 11693
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5846 participants 5847 participants 11693 participants
43.4  (17.4) 43.5  (17.3) 43.5  (17.3)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5846 participants 5847 participants 11693 participants
Female
3849
  65.8%
3820
  65.3%
7669
  65.6%
Male
1997
  34.2%
2027
  34.7%
4024
  34.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 5846 participants 5847 participants 11693 participants
White 4050 4003 8053
Black/African American 396 401 797
Asian 848 907 1755
Native Hawaiian/Pacific Islander 3 3 6
American Indian/Alaska Native 225 207 432
Other 324 326 650
1.Primary Outcome
Title Number of Participants Experiencing an Event in the Composite Endpoint (Asthma-related Death, Asthma-related Intubation or Asthma-related Hospitalization)
Hide Description Number of participants experiencing an event in the composite endpoint (asthma-related death, asthma-related intubation or asthma-related hospitalization), using events adjudicated and confirmed by the Joint Adjudication Committee. Cox proportional hazards model with terms for randomized treatment and strata for incoming control/asthma treatment was used to compare Symbicort and budesonide. Hazard ratios and 95% confidence intervals were estimated.
Time Frame Up to 27 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) population comprised of all patients randomized to study drug.
Arm/Group Title Symbicort Budesonide
Hide Arm/Group Description:
Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
Overall Number of Participants Analyzed 5846 5847
Measure Type: Number
Unit of Measure: Participants
43 40
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Symbicort, Budesonide
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The upper limit of the 95% CI of the hazard ratio will be used to assess statistical non-inferiority (non-inferiority margin=2).
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.073
Confidence Interval (2-Sided) 95%
0.698 to 1.650
Estimation Comments [Not Specified]
2.Primary Outcome
Title Number of Participants Experiencing an Event Included in the Definition of Asthma Exacerbation
Hide Description Number of participants experiencing an event included in the definition of asthma exacerbation. An asthma exacerbation was defined as a deterioration of asthma requiring systemic corticosteroids for at least 3 days or an inpatient hospitalization or emergency room visit due to asthma that required systemic corticosteroids. Cox proportional hazards model with terms for randomized treatment and strata for incoming control/asthma treatment was used to compare Symbicort and budesonide. Hazard ratios and 95% confidence intervals were estimated.
Time Frame Up to 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The On treatment Analysis set comprised of all randomized patients and included data that corresponded to each patient’s period of exposure to study drug plus 7 days after the last date of study drug treatment.
Arm/Group Title Symbicort Budesonide
Hide Arm/Group Description:
Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
Overall Number of Participants Analyzed 5846 5847
Measure Type: Number
Unit of Measure: Participants
539 633
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Symbicort, Budesonide
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.835
Confidence Interval (2-Sided) 95%
0.745 to 0.937
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percent of Days With no Asthma Symptoms
Hide Description Percent of days with no asthma symptoms during the randomized treatment period. Analysis of variance (ANOVA) model including the fixed factors of treatment and strata by incoming control/asthma treatment was used to compare Symbicort and budesonide.
Time Frame Daily up to 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) population comprised of all patients randomized to study drug and had at least one entry of diary data after randomization.
Arm/Group Title Symbicort Budesonide
Hide Arm/Group Description:
Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
Overall Number of Participants Analyzed 5784 5796
Least Squares Mean (Standard Error)
Unit of Measure: Percentage of days
81.1  (0.4) 76.8  (0.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Symbicort, Budesonide
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.4
Confidence Interval (2-Sided) 95%
3.3 to 5.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.5
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percent of Days With Activity Limitation Due to Asthma
Hide Description Percent of days with activity limitation due to asthma during the randomized treatment period. Analysis of variance (ANOVA) model including the fixed factors of treatment and strata by incoming control/asthma treatment was used to compare Symbicort and budesonide.
Time Frame Daily up to 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) population comprised of all patients randomized to study drug. The analysis set comprises of all patients with at least one day with asthma symptoms, i.e. the denominator is the number of days with asthma symptoms.
Arm/Group Title Symbicort Budesonide
Hide Arm/Group Description:
Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
Overall Number of Participants Analyzed 4895 5045
Least Squares Mean (Standard Error)
Unit of Measure: Percentage of days
19.7  (0.4) 19.1  (0.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Symbicort, Budesonide
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.272
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
-0.5 to 1.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.6
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Mean Number of Puffs of Rescue Medication Per 24 Hours
Hide Description Mean number of puffs of rescue medication per day (24 hours) during the randomized treatment period. Analysis of variance (ANOVA) model including the fixed factors of treatment and strata by incoming control/asthma treatment was used to compare Symbicort and budesonide.
Time Frame Daily up to 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) population comprised of all patients randomized to study drug and had at least one entry of diary data after randomization.
Arm/Group Title Symbicort Budesonide
Hide Arm/Group Description:
Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
Overall Number of Participants Analyzed 5784 5796
Least Squares Mean (Standard Error)
Unit of Measure: Inhalations/day
0.8  (0.0) 0.9  (0.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Symbicort, Budesonide
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.2 to -0.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Asthma Control Questionnaire (ACQ6)
Hide Description

The outcome variable for ACQ6 was the difference between the average of values recorded during the treatment period (day 28, day 84 and day 182) and the baseline measure. Analysis of covariance (ANCOVA) model, including the fixed factors of treatment and strata by incoming control/asthma treatment and baseline ACQ6 as covariate was used to compare Symbicort and budesonide.

The asthma control questionnaire, ACQ6, consists of six questions; all assessed on a 7-point scale from 0 to 6, where 0 represents good control and 6 represents poor control. The overall score is the mean of the responses to each of the six questions.

Time Frame baseline, day 28, day 84, day 182
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) population comprised of all patients randomized to study drug with at least one post-baseline ACQ6 score.
Arm/Group Title Symbicort Budesonide
Hide Arm/Group Description:
Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
Overall Number of Participants Analyzed 5701 5698
Least Squares Mean (Standard Error)
Unit of Measure: ACQ6 overall score change from baseline
-0.70  (0.01) -0.62  (0.01)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Symbicort, Budesonide
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.08
Confidence Interval (2-Sided) 95%
-0.10 to -0.06
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.01
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percent of Nights With Awakening(s) Due to Asthma
Hide Description Percent of nights with awakening(s) due to asthma during the randomized treatment period. Analysis of variance (ANOVA) model including the fixed factors of treatment and strata by incoming control/asthma treatment was used to compare Symbicort and budesonide.
Time Frame Daily up to 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) population comprised of all patients randomized to study drug and had at least one entry of diary data after randomization.
Arm/Group Title Symbicort Budesonide
Hide Arm/Group Description:
Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
Overall Number of Participants Analyzed 5784 5796
Least Squares Mean (Standard Error)
Unit of Measure: Percentage of nights
4.0  (0.2) 4.7  (0.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Symbicort, Budesonide
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.6
Confidence Interval (2-Sided) 95%
-1.0 to -0.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Number of Participants Experiencing Discontinuation of Investigational Product Due to a Protocol Defined Asthma Exacerbation
Hide Description Number of participants experiencing discontinuation of investigational product due to a protocol defined asthma exacerbation. An asthma exacerbation was defined as a deterioration of asthma requiring systemic corticosteroids for at least 3 days or an inpatient hospitalization or emergency room visit due to asthma that required systemic corticosteroids. Cox proportional hazards model with terms for randomized treatment and strata for incoming control/asthma treatment was used to compare Symbicort and budesonide. Hazard ratios and 95% confidence intervals were estimated.
Time Frame Up to 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The On treatment Analysis set comprised of all randomized patients and included data that corresponded to each patient’s period of exposure to study drug plus 7 days after the last date of study drug treatment.
Arm/Group Title Symbicort Budesonide
Hide Arm/Group Description:
Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
Overall Number of Participants Analyzed 5846 5847
Measure Type: Number
Unit of Measure: Participants
53 71
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Symbicort, Budesonide
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.095
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.739
Confidence Interval (2-Sided) 95%
0.518 to 1.055
Estimation Comments [Not Specified]
Time Frame Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period, up to 27 weeks.
Adverse Event Reporting Description AEs were not collected unless they lead to discontinuation or qualified as an SAE.
 
Arm/Group Title Symbicort Budesonide
Hide Arm/Group Description Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening). Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
All-Cause Mortality
Symbicort Budesonide
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Symbicort Budesonide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   125/5846 (2.14%)      123/5847 (2.10%)    
Blood and lymphatic system disorders     
Lymphadenopathy mediastinal  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Pancytopenia  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Cardiac disorders     
Acute myocardial infarction  1  1/5846 (0.02%)  1 1/5847 (0.02%)  1
Angina pectoris  1  3/5846 (0.05%)  3 1/5847 (0.02%)  1
Angina unstable  1  2/5846 (0.03%)  2 1/5847 (0.02%)  1
Arrhythmia  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Atrial fibrillation  1  0/5846 (0.00%)  0 3/5847 (0.05%)  3
Atrial flutter  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Cardiac failure chronic  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Cardiac failure congestive  1  2/5846 (0.03%)  2 0/5847 (0.00%)  0
Cardiopulmonary failure  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Coronary artery disease  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Coronary artery insufficiency  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Hypertensive heart disease  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Mitral valve stenosis  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Myocardial infarction  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Myocardial ischaemia  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Myocarditis  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Supraventricular tachycardia  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Tachycardia  1  0/5846 (0.00%)  0 2/5847 (0.03%)  2
Ear and labyrinth disorders     
Vertigo  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Gastrointestinal disorders     
Abdominal hernia  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Abdominal pain  1  2/5846 (0.03%)  2 2/5847 (0.03%)  2
Abdominal pain upper  1  0/5846 (0.00%)  0 3/5847 (0.05%)  3
Colitis  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Colitis ulcerative  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Diarrhoea  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Dyspepsia  1  1/5846 (0.02%)  1 1/5847 (0.02%)  1
Erosive oesophagitis  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Food poisoning  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Gastric ulcer perforation  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Gastritis  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Gastrooesophageal reflux disease  1  2/5846 (0.03%)  2 2/5847 (0.03%)  2
Haematochezia  1  1/5846 (0.02%)  1 1/5847 (0.02%)  1
Haemorrhoids  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Hiatus hernia  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Inguinal hernia  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Intussusception  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Oesophagitis haemorrhagic  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Pancreatitis acute  1  1/5846 (0.02%)  1 1/5847 (0.02%)  1
Peritoneal haemorrhage  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Umbilical hernia  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
General disorders     
Chest pain  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Death  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Device dislocation  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Influenza like illness  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Non-cardiac chest pain  1  1/5846 (0.02%)  1 2/5847 (0.03%)  2
Hepatobiliary disorders     
Biliary colic  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Biliary dyskinesia  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Cholecystitis  1  1/5846 (0.02%)  1 1/5847 (0.02%)  1
Cholelithiasis  1  2/5846 (0.03%)  2 1/5847 (0.02%)  1
Hepatic cirrhosis  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Hepatic steatosis  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Hepatitis  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Immune system disorders     
Allergic granulomatous angiitis  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Anaphylactic reaction  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Anaphylactic shock  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Hypersensitivity  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Infections and infestations     
Abdominal abscess  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Acute sinusitis  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Appendicitis  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Bronchitis  1  1/5846 (0.02%)  1 1/5847 (0.02%)  1
Bronchitis bacterial  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Cellulitis  1  1/5846 (0.02%)  1 1/5847 (0.02%)  1
Clostridium difficile infection  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Cystitis  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Diarrhoea infectious  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Dysentery  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Gastroenteritis  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Gastroenteritis norovirus  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Haemophilus infection  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Herpes zoster  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Influenza  1  0/5846 (0.00%)  0 2/5847 (0.03%)  2
Lower respiratory tract infection bacterial  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Malaria  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Mycoplasma infection  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Nasopharyngitis  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Osteomyelitis  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Pharyngitis  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Pharyngotonsillitis  1  1/5846 (0.02%)  1 1/5847 (0.02%)  1
Pneumonia  1  12/5846 (0.21%)  12 6/5847 (0.10%)  6
Pneumonia bacterial  1  2/5846 (0.03%)  2 3/5847 (0.05%)  3
Postoperative wound infection  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Rhinitis  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Sepsis  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Sinusitis  1  2/5846 (0.03%)  2 1/5847 (0.02%)  1
Tuberculous pleurisy  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Upper respiratory tract infection bacterial  1  0/5846 (0.00%)  0 2/5847 (0.03%)  2
Injury, poisoning and procedural complications     
Ankle fracture  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Burns first degree  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Burns second degree  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Cervical vertebral fracture  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Contusion  1  1/5846 (0.02%)  1 1/5847 (0.02%)  1
Electric shock  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Femur fracture  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Foot fracture  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Incisional hernia  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Muscle strain  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Rib fracture  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Road traffic accident  1  1/5846 (0.02%)  1 1/5847 (0.02%)  1
Tibia fracture  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Ulna fracture  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Upper limb fracture  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Wound  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Investigations     
Blood pressure increased  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Heart rate irregular  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Metabolism and nutrition disorders     
Dehydration  1  2/5846 (0.03%)  2 0/5847 (0.00%)  0
Diabetic ketoacidosis  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Hyperglycaemia  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Hyperosmolar hyperglycaemic state  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Hypokalaemia  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Obesity  1  2/5846 (0.03%)  2 1/5847 (0.02%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Back pain  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Cervical spinal stenosis  1  1/5846 (0.02%)  2 0/5847 (0.00%)  0
Intervertebral disc degeneration  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Lumbar spinal stenosis  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Musculoskeletal chest pain  1  0/5846 (0.00%)  0 3/5847 (0.05%)  3
Osteoarthritis  1  1/5846 (0.02%)  1 1/5847 (0.02%)  1
Rotator cuff syndrome  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Spinal osteoarthritis  1  0/5846 (0.00%)  0 2/5847 (0.03%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Astrocytoma malignant  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Breast cancer female  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Colon cancer  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Colorectal adenocarcinoma  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Gastric cancer  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Invasive ductal breast carcinoma  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Ovarian germ cell teratoma benign  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Squamous cell carcinoma  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Uterine leiomyoma  1  2/5846 (0.03%)  2 0/5847 (0.00%)  0
Nervous system disorders     
Cerebral haematoma  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Cerebral infarction  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Cerebrospinal fluid leakage  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Cerebrovascular accident  1  0/5846 (0.00%)  0 3/5847 (0.05%)  4
Cerebrovascular disorder  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Hypoaesthesia  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Monoparesis  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Seizure  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Syncope  1  3/5846 (0.05%)  3 1/5847 (0.02%)  1
Pregnancy, puerperium and perinatal conditions     
Hyperemesis gravidarum  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Psychiatric disorders     
Aggression  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Bipolar I disorder  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Completed suicide  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Depression  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Stress  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Suicide attempt  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Renal and urinary disorders     
Acute kidney injury  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Hydronephrosis  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Nephritis  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Nephrolithiasis  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Pelvi-ureteric obstruction  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Urinary tract infection  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Reproductive system and breast disorders     
Haemorrhagic ovarian cyst  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Menometrorrhagia  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Ovarian cyst  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Pelvic prolapse  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Uterine haemorrhage  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Asthma  1  35/5846 (0.60%)  38 36/5847 (0.62%)  39
Cough  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Dyspnoea  1  1/5846 (0.02%)  1 2/5847 (0.03%)  2
Pneumonitis  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Respiratory distress  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Rhinitis allergic  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Status asthmaticus  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Vocal cord disorder  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Vascular disorders     
Deep vein thrombosis  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Haematoma  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Hypertension  1  0/5846 (0.00%)  0 1/5847 (0.02%)  1
Venous thrombosis limb  1  1/5846 (0.02%)  1 0/5847 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Symbicort Budesonide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/5846 (0.00%)      0/5847 (0.00%)    
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.
≥ 60 days prior to submission of material for publication/presentation, Institution and PI shall jointly provide AZ with material for review. No publication/presentation may include any of AZ’s Confidential Information without AZ’s written approval. AZ can request Inst. and PI to withhold material from submission for publication/presentation for an additional 90 days to allow AZ to establish and preserve its proprietary rights in the material being submitted for publication or presentation.
Results Point of Contact
Name/Title: Carin Jorup, Global Clinical Lead (GCL) SYMBICORT
Organization: AstraZeneca Research and Development
Phone: +46 31 7761000
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01444430     History of Changes
Other Study ID Numbers: D5896C00027
2011-002790-28 ( EudraCT Number )
First Submitted: September 23, 2011
First Posted: September 30, 2011
Results First Submitted: April 8, 2016
Results First Posted: December 15, 2016
Last Update Posted: December 15, 2016