Asthma
Conditions
Brief summary
This is a comparison of the efficacy of the Symbicort breath actuated dose inhaler to the Symbicort pressured meter dose inhaler after 12 weeks of a twice a day dose.
Interventions
DRUGSymbicort
Breath actuated metered dose inhaler
DRUGBudesonide
Actuation counter pressured metered dose inhaler
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female 12 years and above * Clinical diagnosis of asthma according to the American Thoracic Society definition at least 6 months * Pre-bronchodilator FEV1 ≥ 45% and ≤ 85% of predicted normal * Patients with reversible airway obstruction * Documented daily use of inhaled corticosteroids for ≥ 3 months
Exclusion criteria
* History of life-threatening asthma, defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures during the 2 years prior to Visit 2 * Hospitalized during previous 6 months for asthma * Required emergency treatment more than once during previous 6 months for an asthma-related condition * Intake of oral, rectal or parenteral glucocorticosteroid within 30 days of enrolment * Respiratory infection affecting the asthma within 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Forced Expiratory Volume in 1 Second (FEV1) - Post Dose | 60 minutes post-dose in clinic visits at baseline, and week 0, 3, 7, 12 and Trt Avg | 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. |
| Forced Expiratory Volume in 1 Second (FEV1) - Pre Dose | Pre AM dose in clinic visits at baseline, and week 3, 7, 12 and Trt Avg | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peak Expiratory Flow | Recorded morning upon rising and evening before sleep for 14 weeks | — |
| Asthma Symptoms Score (Total) | Recorded between 6:00 - 11:00 AM from previous 12 hours and 6:00 -11:00 PM from previous 12 hours for 14 weeks | 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. |
| Night-time Awakenings Due to Asthma Symptoms(% Awakening-free Nights) | Recorded 6:00 - 11:00 AM for 14 weeks | 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. |
| Use of Rescue Medication Day and Night (Total Daily Rescue Medication Use) | Recorded between 6:00 - 11:00 AM from previous 12 hours and 6:00 -11:00 PM from previous 12 hours for 14 weeks | 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. |
Countries
Bulgaria, Hungary, Russia, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Symbicort BA MDI Symbicort BA MDI 2x160/4.5 μg twice daily | 71 |
| Symbicort pMDI Symbicort AC pDMI 2x160/4.5 μg twice daily | 71 |
| Budesonide Budesonide AC pMDI 2x160 μg twice daily | 72 |
| Total | 214 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 3 | 3 |
| Overall Study | Eligibility criteria + other | 2 | 1 | 1 |
| Overall Study | Protocol Violation | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 0 | 2 |
Baseline characteristics
| Characteristic | Total | Symbicort BA MDI | Symbicort pMDI | Budesonide |
|---|---|---|---|---|
| Age, Continuous | 42.72 Years STANDARD_DEVIATION 15.77 | 42.83 Years STANDARD_DEVIATION 16.156 | 42.62 Years STANDARD_DEVIATION 16.873 | 42.72 Years STANDARD_DEVIATION 14.424 |
| Age, Customized 12 - <18 years | 21 Participants | 6 Participants | 8 Participants | 7 Participants |
| Age, Customized 18 - <65 years | 178 Participants | 60 Participants | 56 Participants | 62 Participants |
| Age, Customized 65 - <75 years | 10 Participants | 4 Participants | 4 Participants | 2 Participants |
| Age, Customized >= 75 years | 5 Participants | 1 Participants | 3 Participants | 1 Participants |
| Baseline % Predicted FEV1 (Visit 4) | 67.79 % STANDARD_DEVIATION 10.898 | 67.78 % STANDARD_DEVIATION 11.059 | 67.31 % STANDARD_DEVIATION 10.683 | 68.27 % STANDARD_DEVIATION 11.078 |
| % Predicted FEV1 (Visit 2) | 66.93 % STANDARD_DEVIATION 10.434 | 67.27 % STANDARD_DEVIATION 10.048 | 65.02 % STANDARD_DEVIATION 11.135 | 68.49 % STANDARD_DEVIATION 9.924 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 4 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 27 Participants | 9 Participants | 7 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 177 Participants | 57 Participants | 63 Participants | 57 Participants |
| % Reversibility in FEV1 (Visit 2) | 25.20 % STANDARD_DEVIATION 14.491 | 23.93 % STANDARD_DEVIATION 15.728 | 28.04 % STANDARD_DEVIATION 14.712 | 23.64 % STANDARD_DEVIATION 12.692 |
| % Reversibility in FEV1 (Visit 3) | 26.51 % STANDARD_DEVIATION 15.692 | 26.43 % STANDARD_DEVIATION 16.662 | 28.22 % STANDARD_DEVIATION 16.118 | 24.88 % STANDARD_DEVIATION 14.235 |
| Sex: Female, Male Female | 119 Participants | 37 Participants | 47 Participants | 35 Participants |
| Sex: Female, Male Male | 95 Participants | 34 Participants | 24 Participants | 37 Participants |
| Years since asthma diagnosis | 24.25 Years STANDARD_DEVIATION 14.998 | 24.26 Years STANDARD_DEVIATION 14.891 | 24.12 Years STANDARD_DEVIATION 15.128 | 24.38 Years STANDARD_DEVIATION 15.183 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 71 | 2 / 71 | 7 / 71 |
| serious Total, serious adverse events | 0 / 71 | 0 / 71 | 1 / 71 |
Outcome results
Primary
Forced Expiratory Volume in 1 Second (FEV1) - Post Dose
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
Population: 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 | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Symbicort BA MDI | Forced Expiratory Volume in 1 Second (FEV1) - Post Dose | Baseline | 2.09 Liter | Geometric Coefficient of Variation 31.46 |
| Symbicort BA MDI | Forced Expiratory Volume in 1 Second (FEV1) - Post Dose | Week 0 | 2.49 Liter | Geometric Coefficient of Variation 32.14 |
| Symbicort BA MDI | Forced Expiratory Volume in 1 Second (FEV1) - Post Dose | Week 3 | 2.52 Liter | Geometric Coefficient of Variation 31.98 |
| Symbicort BA MDI | Forced Expiratory Volume in 1 Second (FEV1) - Post Dose | Week 7 | 2.59 Liter | Geometric Coefficient of Variation 32.17 |
| Symbicort BA MDI | Forced Expiratory Volume in 1 Second (FEV1) - Post Dose | Week 12 | 2.52 Liter | Geometric Coefficient of Variation 30.71 |
| Symbicort BA MDI | Forced Expiratory Volume in 1 Second (FEV1) - Post Dose | Treatment Average | 2.53 Liter | Geometric Coefficient of Variation 30.57 |
| Symbicort pMDI | Forced Expiratory Volume in 1 Second (FEV1) - Post Dose | Treatment Average | 2.37 Liter | Geometric Coefficient of Variation 26.33 |
| Symbicort pMDI | Forced Expiratory Volume in 1 Second (FEV1) - Post Dose | Baseline | 1.97 Liter | Geometric Coefficient of Variation 27.16 |
| Symbicort pMDI | Forced Expiratory Volume in 1 Second (FEV1) - Post Dose | Week 7 | 2.35 Liter | Geometric Coefficient of Variation 27.22 |
| Symbicort pMDI | Forced Expiratory Volume in 1 Second (FEV1) - Post Dose | Week 12 | 2.39 Liter | Geometric Coefficient of Variation 27.31 |
| Symbicort pMDI | Forced Expiratory Volume in 1 Second (FEV1) - Post Dose | Week 0 | 2.35 Liter | Geometric Coefficient of Variation 25.97 |
| Symbicort pMDI | Forced Expiratory Volume in 1 Second (FEV1) - Post Dose | Week 3 | 2.34 Liter | Geometric Coefficient of Variation 26.31 |
| Budesonide | Forced Expiratory Volume in 1 Second (FEV1) - Post Dose | Week 0 | 2.28 Liter | Geometric Coefficient of Variation 27.18 |
| Budesonide | Forced Expiratory Volume in 1 Second (FEV1) - Post Dose | Week 3 | 2.30 Liter | Geometric Coefficient of Variation 30.22 |
| Budesonide | Forced Expiratory Volume in 1 Second (FEV1) - Post Dose | Treatment Average | 2.30 Liter | Geometric Coefficient of Variation 28.36 |
| Budesonide | Forced Expiratory Volume in 1 Second (FEV1) - Post Dose | Week 7 | 2.33 Liter | Geometric Coefficient of Variation 29.29 |
| Budesonide | Forced Expiratory Volume in 1 Second (FEV1) - Post Dose | Baseline | 2.12 Liter | Geometric Coefficient of Variation 26.34 |
| Budesonide | Forced Expiratory Volume in 1 Second (FEV1) - Post Dose | Week 12 | 2.30 Liter | Geometric Coefficient of Variation 28.27 |
Comparison: The comparison of Symbicort AC pMDI 2x160/4.5 µg bid with budesonide AC pMDI 2x160 µg bid for post dose FEV1p-value: 0.00195% CI: [1.06, 1.14]ANCOVA
Comparison: The comparisons of Symbicort BA MDI 2x160/4.5 µg bid with Symbicort AC pMDI 2x160/4.5 µg bid for post dose FEV1.95% CI: [0.97, 1.05]ANCOVA
Primary
Forced Expiratory Volume in 1 Second (FEV1) - Pre Dose
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
Population: 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 | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Symbicort BA MDI | Forced Expiratory Volume in 1 Second (FEV1) - Pre Dose | Week 12 | 2.34 Liters | Geometric Coefficient of Variation 30.84 |
| Symbicort BA MDI | Forced Expiratory Volume in 1 Second (FEV1) - Pre Dose | Week 7 | 2.40 Liters | Geometric Coefficient of Variation 32.86 |
| Symbicort BA MDI | Forced Expiratory Volume in 1 Second (FEV1) - Pre Dose | Baseline | 2.09 Liters | Geometric Coefficient of Variation 31.46 |
| Symbicort BA MDI | Forced Expiratory Volume in 1 Second (FEV1) - Pre Dose | Week 3 | 2.32 Liters | Geometric Coefficient of Variation 32.79 |
| Symbicort BA MDI | Forced Expiratory Volume in 1 Second (FEV1) - Pre Dose | Average of treatment period | 2.34 Liters | Geometric Coefficient of Variation 30.15 |
| Symbicort pMDI | Forced Expiratory Volume in 1 Second (FEV1) - Pre Dose | Week 7 | 2.11 Liters | Geometric Coefficient of Variation 29.96 |
| Symbicort pMDI | Forced Expiratory Volume in 1 Second (FEV1) - Pre Dose | Baseline | 1.97 Liters | Geometric Coefficient of Variation 27.16 |
| Symbicort pMDI | Forced Expiratory Volume in 1 Second (FEV1) - Pre Dose | Week 3 | 2.12 Liters | Geometric Coefficient of Variation 28.29 |
| Symbicort pMDI | Forced Expiratory Volume in 1 Second (FEV1) - Pre Dose | Week 12 | 2.17 Liters | Geometric Coefficient of Variation 31.29 |
| Symbicort pMDI | Forced Expiratory Volume in 1 Second (FEV1) - Pre Dose | Average of treatment period | 2.15 Liters | Geometric Coefficient of Variation 29.15 |
| Budesonide | Forced Expiratory Volume in 1 Second (FEV1) - Pre Dose | Average of treatment period | 2.23 Liters | Geometric Coefficient of Variation 29.36 |
| Budesonide | Forced Expiratory Volume in 1 Second (FEV1) - Pre Dose | Week 12 | 2.23 Liters | Geometric Coefficient of Variation 30.15 |
| Budesonide | Forced Expiratory Volume in 1 Second (FEV1) - Pre Dose | Baseline | 2.12 Liters | Geometric Coefficient of Variation 26.34 |
| Budesonide | Forced Expiratory Volume in 1 Second (FEV1) - Pre Dose | Week 7 | 2.25 Liters | Geometric Coefficient of Variation 29.01 |
| Budesonide | Forced Expiratory Volume in 1 Second (FEV1) - Pre Dose | Week 3 | 2.22 Liters | Geometric Coefficient of Variation 31.21 |
Comparison: The comparisons of Symbicort BA MDI 2x160/4.5 µg bid with Symbicort AC pMDI 2x160/4.5 µg bid, for pre-dose FEV1.95% CI: [0.99, 1.08]ANCOVA
Secondary
Asthma Symptoms Score (Total)
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Symbicort BA MDI | Asthma Symptoms Score (Total) | Baseline | 2.04 Asthma score on a scale of 0 to 3 | Standard Deviation 0.98 |
| Symbicort BA MDI | Asthma Symptoms Score (Total) | Treatment Average (Trt Avg) | 1.68 Asthma score on a scale of 0 to 3 | Standard Deviation 1.1 |
| Symbicort pMDI | Asthma Symptoms Score (Total) | Baseline | 1.92 Asthma score on a scale of 0 to 3 | Standard Deviation 0.72 |
| Symbicort pMDI | Asthma Symptoms Score (Total) | Treatment Average (Trt Avg) | 1.45 Asthma score on a scale of 0 to 3 | Standard Deviation 0.91 |
| Budesonide | Asthma Symptoms Score (Total) | Baseline | 2.12 Asthma score on a scale of 0 to 3 | Standard Deviation 0.88 |
| Budesonide | Asthma Symptoms Score (Total) | Treatment Average (Trt Avg) | 2.02 Asthma score on a scale of 0 to 3 | Standard Deviation 0.96 |
Comparison: 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.p-value: 0.27295% CI: [-0.1, 0.35]ANCOVA
Secondary
Night-time Awakenings Due to Asthma Symptoms(% Awakening-free Nights)
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Symbicort BA MDI | Night-time Awakenings Due to Asthma Symptoms(% Awakening-free Nights) | Baseline | 78.54 Percentage of days with no awakenings | Standard Deviation 28.97 |
| Symbicort BA MDI | Night-time Awakenings Due to Asthma Symptoms(% Awakening-free Nights) | Treatment Average (Trt Avg) | 83.73 Percentage of days with no awakenings | Standard Deviation 30.9 |
| Symbicort pMDI | Night-time Awakenings Due to Asthma Symptoms(% Awakening-free Nights) | Baseline | 78.76 Percentage of days with no awakenings | Standard Deviation 29.76 |
| Symbicort pMDI | Night-time Awakenings Due to Asthma Symptoms(% Awakening-free Nights) | Treatment Average (Trt Avg) | 89.93 Percentage of days with no awakenings | Standard Deviation 21.4 |
| Budesonide | Night-time Awakenings Due to Asthma Symptoms(% Awakening-free Nights) | Baseline | 81.59 Percentage of days with no awakenings | Standard Deviation 25.32 |
| Budesonide | Night-time Awakenings Due to Asthma Symptoms(% Awakening-free Nights) | Treatment Average (Trt Avg) | 84.62 Percentage of days with no awakenings | Standard Deviation 26.31 |
Comparison: 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.p-value: 0.02595% CI: [-11.41, -0.79]ANCOVA
Secondary
Peak Expiratory Flow
Time frame: Recorded morning upon rising and evening before sleep for 14 weeks
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Symbicort BA MDI | Peak Expiratory Flow | Morning Peak expiratory flow (Baseline) | 357.95 L/Min | Standard Deviation 100.59 |
| Symbicort BA MDI | Peak Expiratory Flow | Evening Peak expiratory flow (Baseline) | 364.61 L/Min | Standard Deviation 103.62 |
| Symbicort BA MDI | Peak Expiratory Flow | Evening Peak expiratory flow (Treatment Average) | 379.96 L/Min | Standard Deviation 104.72 |
| Symbicort BA MDI | Peak Expiratory Flow | Morning Peak expiratory flow (Treatment Average) | 376.28 L/Min | Standard Deviation 106.76 |
| Symbicort pMDI | Peak Expiratory Flow | Morning Peak expiratory flow (Treatment Average) | 353.69 L/Min | Standard Deviation 108.72 |
| Symbicort pMDI | Peak Expiratory Flow | Morning Peak expiratory flow (Baseline) | 335.70 L/Min | Standard Deviation 102.99 |
| Symbicort pMDI | Peak Expiratory Flow | Evening Peak expiratory flow (Treatment Average) | 362.99 L/Min | Standard Deviation 112.63 |
| Symbicort pMDI | Peak Expiratory Flow | Evening Peak expiratory flow (Baseline) | 347.86 L/Min | Standard Deviation 110.8 |
| Budesonide | Peak Expiratory Flow | Morning Peak expiratory flow (Treatment Average) | 343.59 L/Min | Standard Deviation 98.12 |
| Budesonide | Peak Expiratory Flow | Evening Peak expiratory flow (Baseline) | 367.64 L/Min | Standard Deviation 102.73 |
| Budesonide | Peak Expiratory Flow | Evening Peak expiratory flow (Treatment Average) | 348.94 L/Min | Standard Deviation 97.94 |
| Budesonide | Peak Expiratory Flow | Morning Peak expiratory flow (Baseline) | 360.46 L/Min | Standard Deviation 103.09 |
Comparison: 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 bidp-value: 0.82595% CI: [-11.81, 14.8]ANCOVA
Comparison: 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 bidp-value: 0.00195% CI: [20.11, 46.93]ANCOVA
Comparison: 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.p-value: 0.8195% CI: [-10.66, 13.61]ANCOVA
Comparison: 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.p-value: 0.00195% CI: [20.01, 44.49]ANCOVA
Secondary
Use of Rescue Medication Day and Night (Total Daily Rescue Medication Use)
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Symbicort BA MDI | Use of Rescue Medication Day and Night (Total Daily Rescue Medication Use) | Baseline | 2.55 Inhalations/24 hrs | Standard Deviation 2.48 |
| Symbicort BA MDI | Use of Rescue Medication Day and Night (Total Daily Rescue Medication Use) | Treatment Average (Trt Avg) | 1.81 Inhalations/24 hrs | Standard Deviation 2.67 |
| Symbicort pMDI | Use of Rescue Medication Day and Night (Total Daily Rescue Medication Use) | Baseline | 2.19 Inhalations/24 hrs | Standard Deviation 1.75 |
| Symbicort pMDI | Use of Rescue Medication Day and Night (Total Daily Rescue Medication Use) | Treatment Average (Trt Avg) | 1.26 Inhalations/24 hrs | Standard Deviation 1.6 |
| Budesonide | Use of Rescue Medication Day and Night (Total Daily Rescue Medication Use) | Baseline | 2.65 Inhalations/24 hrs | Standard Deviation 2.36 |
| Budesonide | Use of Rescue Medication Day and Night (Total Daily Rescue Medication Use) | Treatment Average (Trt Avg) | 2.34 Inhalations/24 hrs | Standard Deviation 2.38 |
Comparison: 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.p-value: 0.25895% CI: [-0.19, 0.71]ANCOVA