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Trial record 30 of 183 for:    Foradil Combi OR symbicort OR (Budesonide AND formeterol)

New Breath Actuated MDI Symbicort Compared to Symbicort pMDI and Budesonide pMDI for 12 Weeks Twice a Day (BAI)

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ClinicalTrials.gov Identifier: NCT01360021
Recruitment Status : Completed
First Posted : May 25, 2011
Results First Posted : March 11, 2014
Last Update Posted : March 11, 2014
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Asthma
Interventions Drug: Symbicort
Drug: Budesonide
Enrollment 214
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Symbicort BA MDI Symbicort pMDI Budesonide
Hide Arm/Group Description Symbicort BA MDI 2x160/4.5 μg twice daily Symbicort AC pDMI 2x160/4.5 μg twice daily Budesonide AC pMDI 2x160 μg twice daily
Period Title: Overall Study
Started 71 [1] 71 [1] 72 [1]
Completed 63 [2] 67 [2] 65 [2]
Not Completed 8 4 7
Reason Not Completed
Eligibility criteria + other             2             1             1
Protocol Violation             0             0             1
Withdrawal by Subject             4             0             2
Adverse Event             2             3             3
[1]
Patients randomized
[2]
Patients who completed study
Arm/Group Title Symbicort BA MDI Symbicort pMDI Budesonide Total
Hide Arm/Group Description Symbicort BA MDI 2x160/4.5 μg twice daily Symbicort AC pDMI 2x160/4.5 μg twice daily Budesonide AC pMDI 2x160 μg twice daily Total of all reporting groups
Overall Number of Baseline Participants 71 71 72 214
Hide Baseline Analysis Population Description
All Randomized patients
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 71 participants 71 participants 72 participants 214 participants
42.83  (16.156) 42.62  (16.873) 42.72  (14.424) 42.72  (15.770)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 71 participants 71 participants 72 participants 214 participants
12 - <18 years 6 8 7 21
18 - <65 years 60 56 62 178
65 - <75 years 4 4 2 10
>= 75 years 1 3 1 5
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants 71 participants 72 participants 214 participants
Female
37
  52.1%
47
  66.2%
35
  48.6%
119
  55.6%
Male
34
  47.9%
24
  33.8%
37
  51.4%
95
  44.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants 71 participants 72 participants 214 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
4
   5.6%
1
   1.4%
1
   1.4%
6
   2.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
1
   1.4%
1
   0.5%
Black or African American
9
  12.7%
7
   9.9%
11
  15.3%
27
  12.6%
White
57
  80.3%
63
  88.7%
57
  79.2%
177
  82.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   1.4%
0
   0.0%
2
   2.8%
3
   1.4%
Years since asthma diagnosis  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 71 participants 71 participants 72 participants 214 participants
24.26  (14.891) 24.12  (15.128) 24.38  (15.183) 24.25  (14.998)
% Predicted FEV1 (Visit 2)  
Mean (Standard Deviation)
Unit of measure:  %
Number Analyzed 71 participants 71 participants 72 participants 214 participants
67.27  (10.048) 65.02  (11.135) 68.49  (9.924) 66.93  (10.434)
% Reversibility in FEV1 (Visit 2)   [1] 
Mean (Standard Deviation)
Unit of measure:  %
Number Analyzed 71 participants 71 participants 72 participants 214 participants
23.93  (15.728) 28.04  (14.712) 23.64  (12.692) 25.20  (14.491)
[1]
Measure Description: Reversibility is defined as a change of ≥12% in FEV1 from pre-bronchodilator values (for patients ≥12 and <18 years of age), and for patients ≥18 years of age, a change of ≥12% and 200 mL in FEV1 from pre-bronchodilator values. Percent reversibility of FEV1 was calculated as follows: (Post-bronchodilator FEV1 - pre-bronchodilator FEV1)/pre-bronchodilator FEV1 x 100.
% Reversibility in FEV1 (Visit 3)  
Mean (Standard Deviation)
Unit of measure:  %
Number Analyzed 71 participants 71 participants 72 participants 214 participants
26.43  (16.662) 28.22  (16.118) 24.88  (14.235) 26.51  (15.692)
Baseline % Predicted FEV1 (Visit 4)  
Mean (Standard Deviation)
Unit of measure:  %
Number Analyzed 71 participants 71 participants 72 participants 214 participants
67.78  (11.059) 67.31  (10.683) 68.27  (11.078) 67.79  (10.898)
1.Primary Outcome
Title Forced Expiratory Volume in 1 Second (FEV1) - Post Dose
Hide Description Descriptive statistics for post-dose FEV1 (L) by visit; Baseline defined as the last pre-dose value prior to 1st dose of randomized therapy. Trt Avg = Mean of all available valid values after randomization.
Time Frame 60 minutes post-dose in clinic visits at baseline, and week 0, 3, 7, 12 and Trt Avg
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: It consist of all randomized patients who received at least one dose of study medication and contributed sufficient data for at least one efficacy endpoint (Primary variable).
Arm/Group Title Symbicort BA MDI Symbicort pMDI Budesonide
Hide Arm/Group Description:
Symbicort BA MDI 2x160/4.5 μg twice daily
Symbicort AC pDMI 2x160/4.5 μg twice daily
Budesonide AC pMDI 2x160 μg twice daily
Overall Number of Participants Analyzed 71 71 71
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liter
Baseline
2.09
(31.46%)
1.97
(27.16%)
2.12
(26.34%)
Week 0
2.49
(32.14%)
2.35
(25.97%)
2.28
(27.18%)
Week 3
2.52
(31.98%)
2.34
(26.31%)
2.30
(30.22%)
Week 7
2.59
(32.17%)
2.35
(27.22%)
2.33
(29.29%)
Week 12
2.52
(30.71%)
2.39
(27.31%)
2.30
(28.27%)
Treatment Average
2.53
(30.57%)
2.37
(26.33%)
2.30
(28.36%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Symbicort pMDI, Budesonide
Comments The comparison of Symbicort AC pMDI 2x160/4.5 µg bid with budesonide AC pMDI 2x160 µg bid for post dose FEV1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model on the log transformed outcome variable with treatment and country as factor, and log transformed baseline FEV1 (pre-dose) as covariate.
Method of Estimation Estimation Parameter Estimated Geometic Mean Ratio
Estimated Value 1.10
Confidence Interval (2-Sided) 95%
1.06 to 1.14
Estimation Comments Symbicort AC pMDI 2x160/4.5 µg bid vs Budesonide AC pMDI 2x160 µg bid
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Symbicort BA MDI, Symbicort pMDI
Comments The comparisons of Symbicort BA MDI 2x160/4.5 µg bid with Symbicort AC pMDI 2x160/4.5 µg bid for post dose FEV1.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Assuming a standard deviation of 0.2 (for pre dose FEV1) on the log-scale and 60 patients/arm, the width of the confidence interval will extend 0.072 from the point estimate on the log-scale. The lower and upper limits of the CI for the ratio of effects will thus be obtained by multiplying the estimated ratio by 0.931 and 1.075, respectively.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model on the log transformed outcome variable with treatment and country as factor, and log transformed baseline FEV1 (pre-dose) as covariate.
Method of Estimation Estimation Parameter Estimated Geometric Mean Ratio
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.97 to 1.05
Estimation Comments The comparisons was used to assess therapeutic equivalence of Symbicort AC pMDI and Symbicort BA MDI. Assay sensitivity was demonstrated before proceeding to assess therapeutic equivalence of the 2 Symbicort products.
2.Primary Outcome
Title Forced Expiratory Volume in 1 Second (FEV1) - Pre Dose
Hide Description Descriptive statistics for predose FEV1(L) by visit; Baseline defined as the last pre-dose value prior to 1st dose of randomized therapy. Trt Avg = Mean of all available valid values after randomization.
Time Frame Pre AM dose in clinic visits at baseline, and week 3, 7, 12 and Trt Avg
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: It consist of all randomized patients who received at least one dose of study medication and contributed sufficient data for at least one efficacy endpoint (Primary variable).
Arm/Group Title Symbicort BA MDI Symbicort pMDI Budesonide
Hide Arm/Group Description:
Symbicort BA MDI 2x160/4.5 μg twice daily
Symbicort AC pDMI 2x160/4.5 μg twice daily
Budesonide AC pMDI 2x160 μg twice daily
Overall Number of Participants Analyzed 71 71 71
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liters
Baseline
2.09
(31.46%)
1.97
(27.16%)
2.12
(26.34%)
Week 3
2.32
(32.79%)
2.12
(28.29%)
2.22
(31.21%)
Week 7
2.40
(32.86%)
2.11
(29.96%)
2.25
(29.01%)
Week 12
2.34
(30.84%)
2.17
(31.29%)
2.23
(30.15%)
Average of treatment period
2.34
(30.15%)
2.15
(29.15%)
2.23
(29.36%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Symbicort BA MDI, Symbicort pMDI
Comments The comparisons of Symbicort BA MDI 2x160/4.5 µg bid with Symbicort AC pMDI 2x160/4.5 µg bid, for pre-dose FEV1.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Assuming a standard deviation of 0.2 (for pre dose FEV1) on the log-scale and 60 patients/arm, the width of the confidence interval will extend 0.072 from the point estimate on the log-scale. The lower and upper limits of the CI for the ratio of effects will thus be obtained by multiplying the estimated ratio by 0.931 and 1.075, respectively.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model on the log transformed outcome variable with treatment and country as factor, and log transformed baseline FEV1 (pre-dose) as covariate.
Method of Estimation Estimation Parameter Estimated Geometric Mean Ratio
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
0.99 to 1.08
Estimation Comments The comparisons was used to assess therapeutic equivalence of Symbicort AC pMDI and Symbicort BA MDI. Assay sensitivity was demonstrated before proceeding to assess therapeutic equivalence of the 2 Symbicort products.
3.Secondary Outcome
Title Peak Expiratory Flow
Hide Description [Not Specified]
Time Frame Recorded morning upon rising and evening before sleep for 14 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: It consist of all randomized patients who received at least one dose of study medication and contributed sufficient data for at least one efficacy endpoint (Primary variable).
Arm/Group Title Symbicort BA MDI Symbicort pMDI Budesonide
Hide Arm/Group Description:
Symbicort BA MDI 2x160/4.5 μg twice daily
Symbicort AC pDMI 2x160/4.5 μg twice daily
Budesonide AC pMDI 2x160 μg twice daily
Overall Number of Participants Analyzed 71 71 71
Mean (Standard Deviation)
Unit of Measure: L/Min
Morning Peak expiratory flow (Baseline) 357.95  (100.59) 335.70  (102.99) 360.46  (103.09)
Evening Peak expiratory flow (Baseline) 364.61  (103.62) 347.86  (110.80) 367.64  (102.73)
Evening Peak expiratory flow (Treatment Average) 379.96  (104.72) 362.99  (112.63) 348.94  (97.94)
Morning Peak expiratory flow (Treatment Average) 376.28  (106.76) 353.69  (108.72) 343.59  (98.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Symbicort BA MDI, Symbicort pMDI
Comments Morning peak expiratory flow (mPEF): Comparing mean changes from baseline to the average of the double-blind treatment period between Symbicort BA MDI 2x160/4.5 μg bid and Symbicort AC pMDI 2x160/4.5 µg bid
Type of Statistical Test Non-Inferiority or Equivalence
Comments No adjustment were be made for multiplicity for these supportive variables and nominal p-values were reported.
Statistical Test of Hypothesis P-Value 0.825
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model includes treatment and country as a factor and baseline value as covariate.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.49
Confidence Interval (2-Sided) 95%
-11.81 to 14.80
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.75
Estimation Comments Secondary efficacy variables were analyzed as continuous data, comparing mean changes from baseline to the average of the double-blind treatment period between treatments. No adjustment were made for multiplicity and nominal p-values were reported.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Symbicort pMDI, Budesonide
Comments Morning peak expiratory flow (mPEF): Comparing mean changes from baseline to the average of the double-blind treatment period between Symbicort AC pMDI 2x160/4.5 µg bid minus Budesonide AC pMDI 2x160 µg bid
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model includes treatment and country as a factor and baseline value as covariate.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 33.52
Confidence Interval (2-Sided) 95%
20.11 to 46.93
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.80
Estimation Comments Secondary efficacy variables were analyzed as continuous data, comparing mean changes from baseline to the average of the double-blind treatment period between treatments. No adjustment were made for multiplicity and nominal p-values were reported.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Symbicort BA MDI, Symbicort pMDI
Comments Evening peak expiratory flow (ePEF): Comparing mean changes from baseline to the average of the double-blind treatment period between Symbicort BA MDI 2x160/4.5 μg bid and Symbicort AC pMDI 2x160/4.5 µg bid.
Type of Statistical Test Non-Inferiority or Equivalence
Comments No adjustment were made for multiplicity for these supportive variables and nominal p-values were reported.
Statistical Test of Hypothesis P-Value 0.810
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model includes treatment and country as a factor and baseline value as covariate.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.48
Confidence Interval (2-Sided) 95%
-10.66 to 13.61
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.15
Estimation Comments Secondary efficacy variables were analyzed as continuous data, comparing mean changes from baseline to the average of the double-blind treatment period between treatments. No adjustment were made for multiplicity and nominal p-values were reported.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Symbicort pMDI, Budesonide
Comments Evening peak expiratory flow (ePEF): Comparing mean changes from baseline to the average of the double-blind treatment period between Symbicort AC pMDI 2x160/4.5 µg bid and Budesonide AC pMDI 2x160 µg bid.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model includes treatment and country as a factor and baseline value as covariate.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 32.25
Confidence Interval (2-Sided) 95%
20.01 to 44.49
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.21
Estimation Comments Secondary efficacy variables were analyzed as continuous data, comparing mean changes from baseline to the average of the double-blind treatment period between treatments. No adjustment were made for multiplicity and nominal p-values were reported.
4.Secondary Outcome
Title Asthma Symptoms Score (Total)
Hide Description The total score is calculated as sum of the morning and evening scores of each day and the treatment period mean score is defined as the mean of all total score recorded during the 12-week treatment period. Trt Avg=Mean total score of double-blind period values.(day/night score ranges from 0 to 3; 0=no asthma symptoms; 3= unable to do normal activities (or to sleep) due to asthma). Higher score represents worse outcome.
Time Frame Recorded between 6:00 – 11:00 AM from previous 12 hours and 6:00 -11:00 PM from previous 12 hours for 14 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: It consist of all randomized patients who received at least one dose of study medication and contributed sufficient data for at least one efficacy endpoint (Primary variable).
Arm/Group Title Symbicort BA MDI Symbicort pMDI Budesonide
Hide Arm/Group Description:
Symbicort BA MDI 2x160/4.5 μg twice daily
Symbicort AC pDMI 2x160/4.5 μg twice daily
Budesonide AC pMDI 2x160 μg twice daily
Overall Number of Participants Analyzed 71 71 71
Mean (Standard Deviation)
Unit of Measure: Asthma score on a scale of 0 to 3
Baseline 2.04  (0.98) 1.92  (0.72) 2.12  (0.88)
Treatment Average (Trt Avg) 1.68  (1.10) 1.45  (0.91) 2.02  (0.96)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Symbicort BA MDI, Symbicort pMDI
Comments Comparing mean changes from baseline to the average of the double-blind treatment period between Symbicort BA MDI 2x160/4.5 μg bid and Symbicort AC pMDI 2x160/4.5 µg bid.
Type of Statistical Test Non-Inferiority or Equivalence
Comments No adjustment were made for multiplicity for these supportive variables and nominal p-values were reported.
Statistical Test of Hypothesis P-Value 0.272
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model includes treatment and country as a factor and baseline value as covariate.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.13
Confidence Interval (2-Sided) 95%
-0.10 to 0.35
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.11
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Night-time Awakenings Due to Asthma Symptoms(% Awakening-free Nights)
Hide Description The percentage of days with no awakenings due to asthma. Baseline= Mean % awakening-free nights during run-in period ; Trt Avg=Mean % awakening-free nights during double-blind period.
Time Frame Recorded 6:00 – 11:00 AM for 14 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: It consist of all randomized patients who received at least one dose of study medication and contributed sufficient data for at least one efficacy endpoint (Primary variable).
Arm/Group Title Symbicort BA MDI Symbicort pMDI Budesonide
Hide Arm/Group Description:
Symbicort BA MDI 2x160/4.5 μg twice daily
Symbicort AC pDMI 2x160/4.5 μg twice daily
Budesonide AC pMDI 2x160 μg twice daily
Overall Number of Participants Analyzed 71 71 71
Mean (Standard Deviation)
Unit of Measure: Percentage of days with no awakenings
Baseline 78.54  (28.97) 78.76  (29.76) 81.59  (25.32)
Treatment Average (Trt Avg) 83.73  (30.90) 89.93  (21.40) 84.62  (26.31)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Symbicort BA MDI, Symbicort pMDI
Comments Comparing mean changes from baseline to the average of the double-blind treatment period between Symbicort BA MDI 2x160/4.5 μg bid and Symbicort AC pMDI 2x160/4.5 µg bid.
Type of Statistical Test Non-Inferiority or Equivalence
Comments No adjustment were made for multiplicity for these supportive variables and nominal p-values were reported.
Statistical Test of Hypothesis P-Value 0.025
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model includes treatment and country as a factor and baseline value as covariate.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -6.10
Confidence Interval (2-Sided) 95%
-11.41 to -0.79
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.69
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Use of Rescue Medication Day and Night (Total Daily Rescue Medication Use)
Hide Description Total daily rescue medication use is calculated as the sum of morning and evening use each day and averaged over the 12 weeks treatment periods to calculate the treatment period mean. Baseline= Mean rescue medication used during run-in period ; Trt Avg=Mean rescue medication used during double-blind period.
Time Frame Recorded between 6:00 – 11:00 AM from previous 12 hours and 6:00 -11:00 PM from previous 12 hours for 14 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: It consist of all randomized patients who received at least one dose of study medication and contributed sufficient data for at least one efficacy endpoint (Primary variable).
Arm/Group Title Symbicort BA MDI Symbicort pMDI Budesonide
Hide Arm/Group Description:
Symbicort BA MDI 2x160/4.5 μg twice daily
Symbicort AC pDMI 2x160/4.5 μg twice daily
Budesonide AC pMDI 2x160 μg twice daily
Overall Number of Participants Analyzed 71 71 71
Mean (Standard Deviation)
Unit of Measure: Inhalations/24 hrs
Baseline 2.55  (2.48) 2.19  (1.75) 2.65  (2.36)
Treatment Average (Trt Avg) 1.81  (2.67) 1.26  (1.60) 2.34  (2.38)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Symbicort BA MDI, Symbicort pMDI
Comments Comparing mean changes from baseline to the average of the double-blind treatment period between BAI Symbicort BA MDI 2x160/4.5 μg bid and pMDI Symbicort AC pMDI 2x160/4.5 µg bid.
Type of Statistical Test Non-Inferiority or Equivalence
Comments No adjustment were made for multiplicity for these supportive variables and nominal p-values were reported.
Statistical Test of Hypothesis P-Value 0.258
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model includes treatment and country as a factor and baseline value as covariate.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.26
Confidence Interval (2-Sided) 95%
-0.19 to 0.71
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.23
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description 'Number of participants in the safety analysis set is (71 for all the group)as 1 patients from the Budesonide group has not taken any dose of the IP, so not included in the Safety population'
 
Arm/Group Title Budesonide Symbicort BA MDI Symbicort pMDI
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
Budesonide Symbicort BA MDI Symbicort pMDI
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Budesonide Symbicort BA MDI Symbicort pMDI
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/71 (0.00%)      0/71 (0.00%)      1/71 (1.41%)    
Infections and infestations       
APPENDICITIS  1  0/71 (0.00%)  0 0/71 (0.00%)  0 1/71 (1.41%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Budesonide Symbicort BA MDI Symbicort pMDI
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/71 (4.23%)      2/71 (2.82%)      7/71 (9.86%)    
Infections and infestations       
VIRAL UPPER RESPIRATORY TRACT INFECTION  1  3/71 (4.23%)  3 2/71 (2.82%)  2 7/71 (9.86%)  7
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
No. of participants in the safety analysis set is (71 for all the group) as 1 patients from the Budesonide group has not taken any dose of the IP, so not included in the Safety population.
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 sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than less than or equal to 180 days from the date of AZ's request to allow for the filing of a patent app or the taking of such measures as AZ deems appropriate to establish and preserve its proprietary rights in teh material being submitted.
Results Point of Contact
Name/Title: Goran Eckerwall, MD
Organization: Astrazeneca
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01360021     History of Changes
Other Study ID Numbers: D589OC00003
First Submitted: May 19, 2011
First Posted: May 25, 2011
Results First Submitted: July 19, 2013
Results First Posted: March 11, 2014
Last Update Posted: March 11, 2014