| Primary | Change From Baseline in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) Averaged Over Treatment Period | Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period | Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure. | Posted | | Mean | Standard Deviation | Liters | | Baseline to 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily. | | OG001 | Budesonide | Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
|---|
| - OG0000.16± 0.31
- OG0010.07± 0.26
|
|
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| Secondary | Change From Baseline in Morning Peak Expiratory Flow (AM PEF) Averaged Over the Treatment Period | Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period | Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure. | Posted | | Mean | Standard Deviation | Liters/minute | | Baseline to 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily. | | OG001 | Budesonide | Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily. |
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| Secondary | Change From Baseline in Evening Peak Expiratory Flow (PM PEF) Averaged Over the Treatment Period | Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period | Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure. | Posted | | Mean | Standard Deviation | Liters/minute | | Baseline to 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily. | | OG001 | Budesonide | Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily. |
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| Secondary | Change From Baseline in Pre-dose Forced Vital Capacity (FVC) Averaged Over the Treatment Period | Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period | Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure. | Posted | | Mean | Standard Deviation | Liters | | Baseline to 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily. | | OG001 | Budesonide | Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily. |
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| Secondary | Change From Baseline in Pre-dose Forced Expiratory Flow (FEF 25-75%) Averaged Over the Treatment Period | Mean change of the FEF (25-75%) value at the baseline (Visit 3) compared to average value of the FEF (25-75%) recorded at visits during treatment period (to week 12). The mean change was calculated. | Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure. | Posted | | Mean | Standard Deviation | Liters/second | | Baseline to 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily. | | OG001 | Budesonide | Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily. |
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| Secondary | Number of First Predefined Asthma Events by Inhaled Corticosteroid (ICS) Dose at Entry | Total number of participants with any first predefined asthma event (decrease in FEV1 ≥ 20%,or to <40% of predicted normal value,12 puffs of albuterol pMDI per day on 3 or more days, decrease in morning PEF ≥ 20% on 3 or more days, use of rescue medication for 2 or more nights, emergency treatment, hospitalization, use of other asthma medication) | | Posted | | Number | | Participants | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily. | | OG001 | Budesonide | Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily. |
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| Secondary | Number of Withdrawals Due to a Predefined Asthma Event | Total number of participants who withdrew due to a predefined asthma event (decrease in FEV1 ≥ 20%,or to <40% of predicted normal value,12 puffs of albuterol pMDI per day on 3 or more days, decrease in morning PEF ≥ 20% on 3 or more days, use of rescue medication for 2 or more nights, emergency treatment, hospitalization, use of other asthma meds) | | Posted | | Number | | Participants | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily. | | OG001 | Budesonide | Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily. |
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| Secondary | Change From Baseline in Total Average Daily Asthma Symptom Score Averaged Over the Treatment Period | Diary assessment of total asthma symptoms score (treatment average) by Inhaled Corticosteroid (ICS) dose at entry. Asthma symptoms are cough, wheeze and shortness of breath. Each symptom is usually rated from 0-3: 0-no symptoms, 1-mild, 2-moderate and 3-severe. Change from baseline (Visit 3) mean value to average value recorded at visits during treatment period | Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure. | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline to 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily. | | OG001 | Budesonide | Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily. |
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| Secondary | Change From Baseline in Nighttime Asthma Symptom Score Averaged Over the Treatment Period | Diary assessment of nighttime asthma symptoms score (treatment average) by ICS dose at entry. Asthma symptoms are cough, wheeze and shortness of breath. Each symptom is usually rated from 0-3: 0-no symptoms, 1-mild, 2-moderate and 3-severe. Change from baseline (Visit 3) mean value to average value recorded at visits during treatment period; full analysis set (FAS) | Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure. | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline to 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily. | | OG001 | Budesonide | Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily. |
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| Secondary | Change From Baseline in Daytime Asthma Symptom Score Averaged Over the Treatment Period | Diary assessment of daytime asthma symptoms score (treatment average) by ICS dose at entry. Asthma symptoms are cough, wheeze and shortness of breath. Each symptom is usually rated from 0-3: 0-no symptoms, 1-mild, 2-moderate and 3-severe. Change from baseline (Visit 3) mean value to average value recorded at visits during treatment period; full analysis set (FAS) | Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure. | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline to 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily. | | OG001 | Budesonide | Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily. |
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| Secondary | Change From Baseline in Awakening-free Nights Averaged Over the Treatment Period | Diary assessment of number of nights free from awakenings due to asthma; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period | Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure. | Posted | | Mean | Standard Deviation | Number of nights | | Baseline to 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily. | | OG001 | Budesonide | Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily. |
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| Secondary | Change From Baseline to the Average in Total Rescue Medication Use Averaged Over the Treatment Period | Diary assessment of total daily puffs of rescue medication used for asthma symptoms relief; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period | Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure. | Posted | | Mean | Standard Deviation | Puffs/day | | Baseline to 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily. | | OG001 | Budesonide | Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily. |
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| Secondary | Change From Baseline to the Average in Nighttime Rescue Medication Use Averaged Over the Treatment Period | Diary assessment of total nighttime puffs of rescue medication used for asthma symptoms relief; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period | Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure. | Posted | | Mean | Standard Deviation | Puffs/day | | Baseline to 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily. | | OG001 | Budesonide | Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily. |
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| Secondary | Change From Baseline to the Average in Daytime Medication Use Averaged Over the Treatment Period | Diary assessment of total daytime puffs of rescue medication used for asthma symptoms relief; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period | Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure. | Posted | | Mean | Standard Deviation | Puffs/day | | Baseline to 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily. | | OG001 | Budesonide | Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily. |
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| Secondary | Change From Baseline to the Average in Rescue Medication-free Days Averaged Over the Treatment Period | Diary assessment of total (percent) days free from rescue medication use for asthma symptoms relief; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period | Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure. | Posted | | Mean | Standard Deviation | percentage of days | | Baseline to 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily. | | OG001 | Budesonide | Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily. |
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| Secondary | Change From Baseline in Asthma Symptom-free Days Averaged Over the Treatment Period | Diary assessment of number (percent) of days free from asthma symptoms by ICS dose at entry; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period | Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure. | Posted | | Mean | Standard Deviation | percentage of days | | Baseline to 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily. | | OG001 | Budesonide | Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily. |
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| Secondary | Change From Baseline to the Average for Asthma-control Days Averaged Over the Treatment Period | Diary assessment of number (percent) of asthma-control days (defined as days that were free of symptoms and nighttime and daytime rescue medication use); mean change from baseline (Visit 3) value to average value recorded at visits during treatment period | Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure. | Posted | | Mean | Standard Deviation | percentage of days | | Baseline to 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily. | | OG001 | Budesonide | Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily. |
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| Secondary | Perception of Onset of Medication Effect at Last Week of Treatment Assessed by Number of Participants Who Agreed With Item 2 on the Onset of Effect Questionnaire (OEQ) | Diary assessment of participants age 12 years and older and 18 years and older who agreed with OEQ Item 2 at last week of treatment - During the past week, you could feel your medication begin to work right away | | Posted | | Number | | Participants | | 12 week | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily. | | OG001 | Budesonide | Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily. |
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| Secondary | Change From Baseline to End of Treatment in Overall Score on the Asthma Quality of Life Questionnaire-Standardized (AQLQ[S]) | Mean change in overall score at end of treatment for participants age 17 years and older (scores ranged from 1 to 7, with higher scores indicating better quality of life); mean change from baseline (Visit 3) value to average value recorded at visits during treatment period | Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure. | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline to 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily. | | OG001 | Budesonide | Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily. |
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| Secondary | Proportion of Participants Who Reported on the Asthma Control Test (ACT) That Their Asthma Was Controlled at the Last Week of Treatment | There are 5 questions in the survey, and each question has 5 responses (total score for each question can range from 1 to 5). To score the survey, responses to the 5 questions are added to yield a total score that ranges from 5 (poor control of asthma control) to 25 (complete control of asthma). Score of 20 or higher was indicative of well-controlled asthma. | | Posted | | Number | | Proportion of Participants | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily. | | OG001 | Budesonide | Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily. |
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| Secondary | Change From Baseline to Last Week of Treatment in Scores on the Asthma Impact Survey (AIS) | There are 6 questions in the survey, and each question has 5 responses (total score for each question can range from 6 to 13). Responses to the 6 questions were added to yield a total score that ranged from 36 to 78. Scoring is based on a norm-based method. Higher AIS scores indicated more asthma impact and poorer quality of life; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period. | | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline to 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily. | | OG001 | Budesonide | Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily. |
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| Secondary | Perception of Onset of Medication Effect at Last Week of Treatment Assessed by Number of Participants Who Agreed With Item 5 on the Onset of Effect Questionnaire (OEQ) | Diary assessment of participants age 12 years and older and 18 years and older who agreed with OEQ Item 5 at last week of treatment - During the past week, you were satisfied with how quickly you felt your study medication began to work. | | Posted | | Number | | Participants | | 12 week | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily. | | OG001 | Budesonide | Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily. |
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| Secondary | Perception of Onset of Medication Effect at First Week of Treatment Assessed by Number of Participants Who Agreed With Item 2 on the Onset of Effect Questionnaire (OEQ) | Diary assessment of participants age 12 years and older and 18 years and older who agreed with OEQ Item 2 at first week of treatment - During the past week, you could feel your medication begin to work right away | | Posted | | Number | | Participants | | 1 week | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily. | | OG001 | Budesonide | Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily. |
| |
| Secondary | Perception of Onset of Medication Effect at First Week of Treatment Assessed by Number of Participants Who Agreed With Item 5 on the Onset of Effect Questionnaire (OEQ) | Diary assessment of participants age 12 years and older and 18 years and older who agreed with OEQ Item 5 at first week of treatment - During the past week, you were satisfied with how quickly you felt your study medication began to work. | | Posted | | Number | | Participants | | 1 week | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily. | | OG001 | Budesonide | Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily. |
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