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Trial record 42 of 183 for:    Foradil Combi OR symbicort OR (Budesonide AND formeterol)

A 12-Week Study in Asthmatic Children Ages 6 to <12 Years, Investigating the Efficacy and Safety of Symbicort pMDI 80/2.25 μg and Symbicort pMDI 80/4.5 μg, Compared With Budesonide pMDI 80 μg (CHASE 3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02091986
Recruitment Status : Completed
First Posted : March 19, 2014
Results First Posted : April 10, 2017
Last Update Posted : April 10, 2017
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
Other: Budesonide pMDI
Enrollment 882
Recruitment Details  
Pre-assignment Details The enrollment number in the protocol section denotes the number of patients screened into the trial. Out of these 882 patients screened, 279 patients were randomized into the trial. This explains the discrepancy in patient number.
Arm/Group Title Symbicort pMDI 80/4.5 ug Symbicort pMDI 80/2.25 ug Budesonide pMDI 80 ug
Hide Arm/Group Description Symbicort pMDI 80/4.5 ug x 2 BID Symbicort pMDI 80/4.5 ug x 2 BID Budesonide pMDI 80 ug x 2 BID
Period Title: Overall Study
Started 92 95 92
Completed 85 84 84
Not Completed 7 11 8
Reason Not Completed
7 rand in error 1 patient decision             2             3             3
Lost to Follow-up             1             0             0
Withdrawal by Subject             4             8             3
Adverse Event             0             0             2
Arm/Group Title Symbicort pMDI 80/4.5 ug Symbicort pMDI 80/2.25 ug Budesonide pMDI 80 ug Total
Hide Arm/Group Description Symbicort pMDI 80/4.5 ug x 2 BID Symbicort pMDI 80/4.5 ug x 2 BID Budesonide pMDI 80 ug x 2 BID Total of all reporting groups
Overall Number of Baseline Participants 92 95 92 279
Hide Baseline Analysis Population Description
All patients randomized, defined as having a randomization code recorded on the demography case report form (CRF)
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 92 participants 95 participants 92 participants 279 participants
9  (1.6) 9  (1.6) 9  (1.4) 9  (1.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants 95 participants 92 participants 279 participants
Female
42
  45.7%
34
  35.8%
37
  40.2%
113
  40.5%
Male
50
  54.3%
61
  64.2%
55
  59.8%
166
  59.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants 95 participants 92 participants 279 participants
Hispanic or Latino
38
  41.3%
36
  37.9%
32
  34.8%
106
  38.0%
Not Hispanic or Latino
54
  58.7%
59
  62.1%
60
  65.2%
173
  62.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants 95 participants 92 participants 279 participants
American Indian or Alaska Native
2
   2.2%
3
   3.2%
3
   3.3%
8
   2.9%
Asian
0
   0.0%
0
   0.0%
2
   2.2%
2
   0.7%
Native Hawaiian or Other Pacific Islander
1
   1.1%
0
   0.0%
0
   0.0%
1
   0.4%
Black or African American
24
  26.1%
26
  27.4%
26
  28.3%
76
  27.2%
White
61
  66.3%
60
  63.2%
53
  57.6%
174
  62.4%
More than one race
4
   4.3%
4
   4.2%
7
   7.6%
15
   5.4%
Unknown or Not Reported
0
   0.0%
2
   2.1%
1
   1.1%
3
   1.1%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 92 participants 95 participants 92 participants 279 participants
38  (12.9) 38  (12.9) 40  (13.6) 39  (13.1)
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 92 participants 95 participants 92 participants 279 participants
139  (11.1) 138  (10.9) 141  (10.5) 139  (10.8)
Duration of asthma  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 92 participants 95 participants 92 participants 279 participants
5.8  (3.0) 5.9  (3.2) 6.2  (3.1) 5.9  (3.1)
FEV1 at randomisation  
Mean (Standard Deviation)
Unit of measure:  Liters
Number Analyzed 92 participants 95 participants 92 participants 279 participants
1.58  (0.42) 1.57  (0.33) 1.62  (0.36) 1.59  (0.37)
1.Primary Outcome
Title Change From Baseline to Week 12 in 1h Post-dose FEV1
Hide Description 1h post-dose FEV1 is defined as the 1-hour post-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).
Time Frame Week 0 (baseline), Week 12
Hide Outcome Measure Data
Hide Analysis Population Description

All patients randomized who:

  • received at least one dose of study medication;
  • the patient contributed data for at least one efficacy endpoint.

Patients accounted for according to the treatment to which they were randomized.

Arm/Group Title Symbicort pMDI 80/4.5 ug Symbicort pMDI 80/2.25 ug Budesonide pMDI 80 ug
Hide Arm/Group Description:
Symbicort pMDI 80/4.5 ug x 2 BID
Symbicort pMDI 80/2.25 ug x 2 BID
Budesonide pMDI 80 ug x 2 BID
Overall Number of Participants Analyzed 90 93 90
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liters
0.28
(0.22 to 0.34)
0.24
(0.18 to 0.31)
0.17
(0.10 to 0.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Symbicort pMDI 80/4.5 ug, Budesonide pMDI 80 ug
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline FEV1, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Symbicort pMDI 80/2.25 ug, Budesonide pMDI 80 ug
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.063
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline FEV1, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Symbicort pMDI 80/4.5 ug, Budesonide pMDI 80 ug
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.373
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline FEV1, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.
2.Secondary Outcome
Title Change From Baseline to Week 12 in 1h Post-dose PEF
Hide Description 1h post-dose PEF is defined as the 1-hour post-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).
Time Frame Week 0 (baseline), Week 12
Hide Outcome Measure Data
Hide Analysis Population Description

All patients randomized who:

  • received at least one dose of study medication;
  • the patient contributed data for at least one efficacy endpoint.

Patients accounted for according to the treatment to which they were randomized.

Arm/Group Title Symbicort pMDI 80/4.5 ug Symbicort pMDI 80/2.25 ug Budesonide pMDI 80 ug
Hide Arm/Group Description:
Symbicort pMDI 80/4.5 ug x 2 BID
Symbicort pMDI 80/2.25 ug x 2 BID
Budesonide pMDI 80 ug x 2 BID
Overall Number of Participants Analyzed 89 93 90
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liters per minute
57.04
(46.12 to 67.97)
41.14
(30.26 to 52.01)
31.57
(20.78 to 42.36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Symbicort pMDI 80/4.5 ug, Budesonide pMDI 80 ug
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 Mixed Models Analysis
Comments Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Symbicort pMDI 80/2.25 ug, Budesonide pMDI 80 ug
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.195
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Symbicort pMDI 80/4.5 ug, Symbicort pMDI 80/2.25 ug
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.032
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.
3.Secondary Outcome
Title Change From Baseline to Week 12 in 1h Post-dose FEF25-75
Hide Description 1h post-dose FEF25-75 is defined as the 1-hour post-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).
Time Frame Week 0 (baseline), Week 12
Hide Outcome Measure Data
Hide Analysis Population Description

All patients randomized who:

  • received at least one dose of study medication;
  • the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized.
Arm/Group Title Symbicort pMDI 80/4.5 ug Symbicort pMDI 80/2.25 ug Budesonide pMDI 80 ug
Hide Arm/Group Description:
Symbicort pMDI 80/4.5 ug x 2 BID
Symbicort pMDI 80/2.25 ug x 2 BID
Budesonide pMDI 80 ug x 2 BID
Overall Number of Participants Analyzed 89 93 90
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liters per second
0.55
(0.43 to 0.67)
0.47
(0.35 to 0.59)
0.23
(0.11 to 0.35)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Symbicort pMDI 80/4.5 ug, Budesonide pMDI 80 ug
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 Mixed Models Analysis
Comments Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Symbicort pMDI 80/2.25 ug, Budesonide pMDI 80 ug
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Symbicort pMDI 80/4.5 ug, Symbicort pMDI 80/2.25 ug
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.326
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.
4.Secondary Outcome
Title Change From Baseline to Week 12 in 1h Post-dose FVC
Hide Description 1h post-dose FVC is defined as the 1-hour post-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).
Time Frame Week 0 (baseline), Week 12
Hide Outcome Measure Data
Hide Analysis Population Description

All patients randomized who:

  • received at least one dose of study medication;
  • the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized.
Arm/Group Title Symbicort pMDI 80/4.5 ug Symbicort pMDI 80/2.25 ug Budesonide pMDI 80 ug
Hide Arm/Group Description:
Symbicort pMDI 80/4.5 ug x 2 BID
Symbicort pMDI 80/2.25 ug x 2 BID
Budesonide pMDI 80 ug x 2 BID
Overall Number of Participants Analyzed 89 93 90
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liters
0.22
(0.15 to 0.30)
0.16
(0.09 to 0.23)
0.17
(0.10 to 0.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Symbicort pMDI 80/4.5 ug, Budesonide pMDI 80 ug
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.276
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Symbicort pMDI 80/2.25 ug, Budesonide pMDI 80 ug
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.759
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Symbicort pMDI 80/4.5 ug, Symbicort pMDI 80/2.25 ug
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.165
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.
5.Secondary Outcome
Title Change From Baseline to Week 12 in Pre-dose FEV1
Hide Description Pre-dose FEV1 is defined as the pre-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).
Time Frame Week 0 (baseline), Week 12
Hide Outcome Measure Data
Hide Analysis Population Description

All patients randomized who:

  • received at least one dose of study medication;
  • the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized.
Arm/Group Title Symbicort pMDI 80/4.5 ug Symbicort pMDI 80/2.25 ug Budesonide pMDI 80 ug
Hide Arm/Group Description:
Symbicort pMDI 80/4.5 ug x 2 BID
Symbicort pMDI 80/2.25 ug x 2 BID
Budesonide pMDI 80 ug x 2 BID
Overall Number of Participants Analyzed 89 92 89
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liters
0.11
(0.04 to 0.17)
0.10
(0.03 to 0.16)
0.09
(0.03 to 0.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Symbicort pMDI 80/4.5 ug, Budesonide pMDI 80 ug
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.724
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Symbicort pMDI 80/2.25 ug, Budesonide pMDI 80 ug
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.909
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Symbicort pMDI 80/4.5 ug, Symbicort pMDI 80/2.25 ug
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.811
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.
6.Secondary Outcome
Title Change From Baseline to Week 12 in Pre-dose PEF
Hide Description Pre-dose PEF is defined as the pre-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).
Time Frame Week 0 (baseline), Week 12
Hide Outcome Measure Data
Hide Analysis Population Description

All patients randomized who:

  • received at least one dose of study medication;
  • the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized.
Arm/Group Title Symbicort pMDI 80/4.5 ug Symbicort pMDI 80/2.25 ug Budesonide pMDI 80 ug
Hide Arm/Group Description:
Symbicort pMDI 80/4.5 ug x 2 BID
Symbicort pMDI 80/2.25 ug x 2 BID
Budesonide pMDI 80 ug x 2 BID
Overall Number of Participants Analyzed 89 92 89
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liters per minute
27.73
(16.37 to 39.08)
15.86
(4.39 to 27.33)
16.01
(4.50 to 27.52)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Symbicort pMDI 80/4.5 ug, Budesonide pMDI 80 ug
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.134
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Symbicort pMDI 80/2.25 ug
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.985
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Symbicort pMDI 80/4.5 ug, Symbicort pMDI 80/2.25 ug
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.128
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.
7.Secondary Outcome
Title Change From Baseline to Week 12 in Pre-dose FEF25-75
Hide Description Pre-dose FEF25-75 is defined as the pre-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).
Time Frame Week 0 (baseline), Week 12
Hide Outcome Measure Data
Hide Analysis Population Description

All patients randomized who:

  • received at least one dose of study medication;
  • the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized.
Arm/Group Title Symbicort pMDI 80/4.5 ug Symbicort pMDI 80/2.25 ug Budesonide pMDI 80 ug
Hide Arm/Group Description:
Symbicort pMDI 80/4.5 ug x 2 BID
Symbicort pMDI 80/2.25 ug x 2 BID
Budesonide pMDI 80 ug x 2 BID
Overall Number of Participants Analyzed 89 92 89
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liters per minute
0.12
(0.01 to 0.24)
0.13
(0.01 to 0.25)
0.09
(-0.03 to 0.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Symbicort pMDI 80/4.5 ug, Budesonide pMDI 80 ug
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.684
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Symbicort pMDI 80/2.25 ug, Budesonide pMDI 80 ug
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.621
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Symbicort pMDI 80/4.5 ug, Symbicort pMDI 80/2.25 ug
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.929
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.
8.Secondary Outcome
Title Change From Baseline to Week 12 in Pre-dose FVC
Hide Description Pre-dose FVC is defined as the pre-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).
Time Frame Week 0 (baseline), Week 12
Hide Outcome Measure Data
Hide Analysis Population Description

All patients randomized who:

  • received at least one dose of study medication;
  • the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized.
Arm/Group Title Symbicort pMDI 80/4.5 ug Symbicort pMDI 80/2.25 ug Budesonide pMDI 80 ug
Hide Arm/Group Description:
Symbicort pMDI 80/4.5 ug x 2 BID
Symbicort pMDI 80/2.25 ug x 2 BID
Budesonide pMDI 80 ug x 2 BID
Overall Number of Participants Analyzed 89 92 89
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liters
0.11
(0.03 to 0.18)
0.11
(0.04 to 0.19)
0.13
(0.05 to 0.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Symbicort pMDI 80/4.5 ug, Budesonide pMDI 80 ug
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.664
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Symbicort pMDI 80/2.25 ug, Budesonide pMDI 80 ug
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.747
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Symbicort pMDI 80/4.5 ug, Symbicort pMDI 80/2.25 ug
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.913
Comments [Not Specified]
Method Mixed Models Analysis
Comments Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.
9.Secondary Outcome
Title Change From Baseline to Week 12 in 15 Min Post-dose FEV1
Hide Description 15 min Post-dose FEV1 is defined as the 15 min post-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).
Time Frame Week 0 (baseline), Week 12
Hide Outcome Measure Data
Hide Analysis Population Description

All patients randomized who:

  • received at least one dose of study medication;
  • the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized.
Arm/Group Title Symbicort pMDI 80/4.5 ug Symbicort pMDI 80/2.25 ug Budesonide pMDI 80 ug
Hide Arm/Group Description:
Symbicort pMDI 80/4.5 ug x 2 BID
Symbicort pMDI 80/2.25 ug x 2 BID
Budesonide pMDI 80 ug x 2 BID
Overall Number of Participants Analyzed 79 78 80
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liters
0.25
(0.18 to 0.31)
0.19
(0.12 to 0.25)
0.15
(0.08 to 0.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Symbicort pMDI 80/4.5 ug, Budesonide pMDI 80 ug
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments [Not Specified]
Method ANCOVA
Comments Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Symbicort pMDI 80/2.25 ug, Budesonide pMDI 80 ug
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.342
Comments [Not Specified]
Method ANCOVA
Comments Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Symbicort pMDI 80/4.5 ug, Symbicort pMDI 80/2.25 ug
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.138
Comments [Not Specified]
Method ANCOVA
Comments Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.
10.Secondary Outcome
Title Change From Baseline to End of Study Average in Total Asthma Symptoms
Hide Description

End of study average is defined as the average of available records from 7 days before up to and including the day prior to withdrawal from study or Week 12, minus the baseline measurement at randomization, for patients who remain in the study (irrespective of whether IP has been discontinued).

Patient to record his/her asthma symptom score twice daily. The following rating scales are to be used: 0 = None; no symptoms of asthma

  1. = Mild symptoms; awareness of asthma symptoms and/or signs that are easily tolerated
  2. = Moderate symptoms, asthma symptoms with some discomfort, causing some interference with daily activities or sleep
  3. = Severe symptoms; incapacitating asthma symptoms and/or signs, with inability to perform daily activities or to sleep

Total asthma symptom score is derived as the sum of the daytime score plus the score from the previous nighttime, ie possible range (0 to 6).

Time Frame Week 0 (baseline), Week 12
Hide Outcome Measure Data
Hide Analysis Population Description

All patients randomized who:

  • received at least one dose of study medication;
  • the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized.
Arm/Group Title Symbicort pMDI 80/4.5 ug Symbicort pMDI 80/2.25 ug Budesonide pMDI 80 ug
Hide Arm/Group Description:
Symbicort pMDI 80/4.5 ug x 2 BID
Symbicort pMDI 80/2.25 ug x 2 BID
Budesonide pMDI 80 ug x 2 BID
Overall Number of Participants Analyzed 70 72 73
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.5  (0.73) -0.6  (0.73) -0.4  (0.55)
11.Secondary Outcome
Title Change From Baseline to End of Study Average in % of Night Time Awakenings Due to Asthma Symptoms
Hide Description End of study average is defined as the percentage of nighttime awakenings due to asthma symptoms from 6 days before up to and additionally including the morning of withdrawal from study or Week 12, minus the baseline measurement at randomization, for patients who remain in the study (irrespective of whether IP has been discontinued).
Time Frame Week 0 (baseline), Week 12
Hide Outcome Measure Data
Hide Analysis Population Description

All patients randomized who:

  • received at least one dose of study medication;
  • the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized.
Arm/Group Title Symbicort pMDI 80/4.5 ug Symbicort pMDI 80/2.25 ug Budesonide pMDI 80 ug
Hide Arm/Group Description:
Symbicort pMDI 80/4.5 ug x 2 BID
Symbicort pMDI 80/2.25 ug x 2 BID
Budesonide pMDI 80 ug x 2 BID
Overall Number of Participants Analyzed 79 85 82
Mean (Standard Deviation)
Unit of Measure: Percentage of nighttime awakenings
-14.0  (29.15) -17.3  (33.16) -13.0  (21.87)
12.Secondary Outcome
Title Change From Baseline to End of Study Average in Total Daily Reliever Medication
Hide Description End of study average is defined as the average of available records from 7 days before up to and including the day prior to withdrawal from study or Week 12, minus the baseline measurement at randomization, for patients who remain in the study (irrespective of whether IP has been discontinued).
Time Frame Week 0 (baseline), Week 12
Hide Outcome Measure Data
Hide Analysis Population Description

All patients randomized who:

  • received at least one dose of study medication;
  • the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized.
Arm/Group Title Symbicort pMDI 80/4.5 ug Symbicort pMDI 80/2.25 ug Budesonide pMDI 80 ug
Hide Arm/Group Description:
Symbicort pMDI 80/4.5 ug x 2 BID
Symbicort pMDI 80/2.25 ug x 2 BID
Budesonide pMDI 80 ug x 2 BID
Overall Number of Participants Analyzed 70 72 73
Mean (Standard Deviation)
Unit of Measure: Number of reliever medication use
-0.7  (1.75) -1.1  (2.37) -0.7  (1.37)
13.Secondary Outcome
Title Change From Baseline to Study Period Average in Overall PAQLQ Score
Hide Description

Study period average is defined as the average of the post-baseline values during the study taken after first dose of investigational product up to and including withdrawal from study or Week 12, minus the baseline assessment at randomization, for patients who remain in the study (irrespective of whether IP has been discontinued).

The PAQLQ(S) is a 23-item patient-reported questionnaire, each one reported on a 7-point scale (e.g. 1 = extremely bothered/all of the time; 7 = not bothered/none of the time). The PAQLQ(S) generates an overall score, as well as 3 domain scores: activity limitations (5 items), symptoms (10 items) and emotional function (8 items). The overall score will be calculated as the mean of the responses to each of the 23 questions (ie the range of 1–7, where higher scores indicate better quality of life). If any of the domain scores are missing, no total score will be calculated.

Time Frame Week 0 (baseline), week 4, week 8, week 12
Hide Outcome Measure Data
Hide Analysis Population Description

All patients randomized who:

  • received at least one dose of study medication;
  • the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized.
Arm/Group Title Symbicort pMDI 80/4.5 ug Symbicort pMDI 80/2.25 ug Budesonide pMDI 80 ug
Hide Arm/Group Description:
Symbicort pMDI 80/4.5 ug x 2 BID
Symbicort pMDI 80/2.25 ug x 2 BID
Budesonide pMDI 80 ug x 2 BID
Overall Number of Participants Analyzed 79 80 82
Least Squares Mean (95% Confidence Interval)
Unit of Measure: unit on a scale
0.46
(0.30 to 0.62)
0.53
(0.38 to 0.69)
0.62
(0.47 to 0.78)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Symbicort pMDI 80/4.5 ug, Budesonide pMDI 80 ug
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.098
Comments [Not Specified]
Method ANCOVA
Comments The explanatory variables included in the model are: treatment group, baseline overall PAQLQ(S) score, region and age group
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Symbicort pMDI 80/2.25 ug, Budesonide pMDI 80 ug
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.367
Comments [Not Specified]
Method ANCOVA
Comments The explanatory variables included in the model are: treatment group, baseline overall PAQLQ(S) score, region and age group
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Symbicort pMDI 80/4.5 ug, Symbicort pMDI 80/2.25 ug
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.449
Comments [Not Specified]
Method ANCOVA
Comments The explanatory variables included in the model are: treatment group, baseline overall PAQLQ(S) score, region and age group
14.Secondary Outcome
Title Number of Patients With an Asthma Exacerbation During Study
Hide Description Number of patients that experienced an asthma exacerbation that required either emergency room treatment, hospitalization, systemic steroids, or an increase in, or additional asthma maintenance medication, during the study.
Time Frame Week 0 (baseline) up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description

All patients randomized who:

  • received at least one dose of study medication;
  • data collected after randomisation. Patients accounted for according to the treatment they actually received.
Arm/Group Title Symbicort pMDI 80/4.5 ug Symbicort pMDI 80/2.25 ug Budesonide pMDI 80 ug
Hide Arm/Group Description:
Symbicort pMDI 80/4.5 ug x 2 BID
Symbicort pMDI 80/2.25 ug x 2 BID
Budesonide pMDI 80 ug x 2 BID
Overall Number of Participants Analyzed 90 93 90
Measure Type: Number
Unit of Measure: Partcicipants
9 12 12
Time Frame Week 0 (baseline) up to 12 weeks
Adverse Event Reporting Description

Serious Adverse Events Table, Other Adverse Events Table based on all of patients rand who :

  • received at least 1 dose of study meds;
  • data were collected after randomization. No of part provided in the Participant Flow Module based on all patients randomized.
 
Arm/Group Title Symbicort pMDI 80/4.5 ug Symbicort pMDI 80/2.25 ug Budesonide pMDI 80 ug
Hide Arm/Group Description Symbicort pMDI 80/4.5 ug x 2 BID Symbicort pMDI 80/4.5 ug x 2 BID Budesonide pMDI 80 ug x 2 BID
All-Cause Mortality
Symbicort pMDI 80/4.5 ug Symbicort pMDI 80/2.25 ug Budesonide pMDI 80 ug
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Symbicort pMDI 80/4.5 ug Symbicort pMDI 80/2.25 ug Budesonide pMDI 80 ug
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/90 (0.00%)   0/93 (0.00%)   2/90 (2.22%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Acute lymphocytic leukaemia  0/90 (0.00%)  0/93 (0.00%)  1/90 (1.11%) 
Respiratory, thoracic and mediastinal disorders       
Asthma  0/90 (0.00%)  0/93 (0.00%)  1/90 (1.11%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Symbicort pMDI 80/4.5 ug Symbicort pMDI 80/2.25 ug Budesonide pMDI 80 ug
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   42/90 (46.67%)   41/93 (44.09%)   40/90 (44.44%) 
Gastrointestinal disorders       
Vomiting  2/90 (2.22%)  3/93 (3.23%)  0/90 (0.00%) 
Nausea  0/90 (0.00%)  0/93 (0.00%)  2/90 (2.22%) 
General disorders       
Pyrexia  4/90 (4.44%)  4/93 (4.30%)  4/90 (4.44%) 
Immune system disorders       
Hypersensitivity  2/90 (2.22%)  0/93 (0.00%)  0/90 (0.00%) 
Infections and infestations       
Upper respiratory tract infection  9/90 (10.00%)  12/93 (12.90%)  4/90 (4.44%) 
Nasopharyngitis  4/90 (4.44%)  2/93 (2.15%)  5/90 (5.56%) 
Pharyngitis  5/90 (5.56%)  3/93 (3.23%)  1/90 (1.11%) 
Sinusitis  2/90 (2.22%)  1/93 (1.08%)  1/90 (1.11%) 
Influenza  1/90 (1.11%)  2/93 (2.15%)  0/90 (0.00%) 
Pharyngitis streptococcal  0/90 (0.00%)  2/93 (2.15%)  1/90 (1.11%) 
Conjunctivitis  1/90 (1.11%)  0/93 (0.00%)  2/90 (2.22%) 
Rhinitis  3/90 (3.33%)  2/93 (2.15%)  2/90 (2.22%) 
Viral upper respiratory tract  0/90 (0.00%)  1/93 (1.08%)  2/90 (2.22%) 
Nervous system disorders       
Headache  4/90 (4.44%)  4/93 (4.30%)  0/90 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Asthma  7/90 (7.78%)  11/93 (11.83%)  10/90 (11.11%) 
Rhinitis allergic  3/90 (3.33%)  3/93 (3.23%)  4/90 (4.44%) 
Cough  1/90 (1.11%)  4/93 (4.30%)  4/90 (4.44%) 
Epistaxis  1/90 (1.11%)  2/93 (2.15%)  1/90 (1.11%) 
Nasal congestion  2/90 (2.22%)  0/93 (0.00%)  2/90 (2.22%) 
Oropharyngeal pain  2/90 (2.22%)  0/93 (0.00%)  1/90 (1.11%) 
Wheezing  1/90 (1.11%)  0/93 (0.00%)  2/90 (2.22%) 
Sinus congestion  0/90 (0.00%)  2/93 (2.15%)  0/90 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Global Clinical Lead Göran Eckerwall
Organization: AstraZeneca
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02091986     History of Changes
Other Study ID Numbers: D589GC00003
First Submitted: March 18, 2014
First Posted: March 19, 2014
Results First Submitted: October 11, 2016
Results First Posted: April 10, 2017
Last Update Posted: April 10, 2017