| Primary | PC 20 Methacholine (Provocative Concentration of Methacholine Causing 20 % Fall in FEV1(Forced Expiratory Volume) | Provocative concentration of methacholine is that causing a 20% fall in FEV1. The methacholine challenge test entailed the patient inhaling from an aerosol containing doubling concentrations of methacholine over a period of 2 minutes until FEV1 had been reduced by 20%. The ratio of Methacholine concentration measured at 2 weeks to that at Baseline. | Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler). | Posted | | Geometric Mean | 95% Confidence Interval | Ratio | | Baseline and week 2 | | | | ID | Title | Description |
|---|
| OG000 | Budesonide Hydrofluoroalkane (HFA) 100 | Budesonide Hydrofluoroalkane (HFA) 100 mcg twice daily for 2 weeks | | OG001 | Budesonide HFA 400 | Budesonide HFA 400 mcg twice daily for 2 weeks | | OG002 | Budesonide Chlorofluorocarbon(CFC) 100 | Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks | | OG003 | Budesonide CFC 400 | Budesonide CFC 400 mcg twice daily for 2 weeks |
| | Units | Counts |
|---|
| Participants | - OG00080
- OG00179
- OG00279
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0001.546(1.343 to 1.780)
- OG0012.163(1.877 to 2.494)
- OG0021.673(1.449 to 1.928)
- OG003
|
|
| |
| Secondary | Peak Exploratory Flow (PEF) | Change in PEF at Week 2 from baseline, mean over all days in run-in and all dasy in treatment period, with baseline as covariate. | Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler). | Posted | | Least Squares Mean | 95% Confidence Interval | Liters/minutes | | Baseline to week 2 recorded daily | | | | ID | Title | Description |
|---|
| OG000 | Budesonide Hydrofluoroalkane (HFA) 100 | Budesonide Hydrofluoroalkane (HFA) 100 mcg twice daily for 2 weeks | | OG001 | Budesonide HFA 400 | Budesonide HFA 400 mcg twice daily for 2 weeks | | OG002 | Budesonide Chlorofluorocarbon(CFC) 100 | Budesonide Chlorofluorocarbon(CFC) 100 mcg twice daily for 2 weeks | | OG003 | Budesonide CFC 400 | Budesonide CFC 400 mcg twice daily for 2 weeks |
| |
| Secondary | FEV1 (Forced Expiratory Volume in 1 Second) | FEV1 change from baseline | Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler). | Posted | | Least Squares Mean | 95% Confidence Interval | Liters | | Baseline to week 2 | | | | ID | Title | Description |
|---|
| OG000 | Budesonide Hydrofluoroalkane(HFA) 100 | Budesonide Hydrofluoroalkane(HFA) 100 mcg twice daily for 2 weeks | | OG001 | Budesonide HFA 400 | Budesonide HFA 400 mcg twice daily for 2 weeks | | OG002 | Budesonide Chlorofluorocarbon (CFC) 100 | Budesonide Chlorofluorocarbon(CFC) 100 mcg twice daily for 2 weeks | | OG003 | Budesonide CFC 400 | Budesonide CFC 400 mcg twice daily for 2 weeks |
| |
| Secondary | FEF 25-75 (Forced Expiratory Flow 25-75) | FEF 25-75- Forced expiratory flow over the middle one half of the FVC. The results are expressed as the change from baseline | Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler). | Posted | | Least Squares Mean | 95% Confidence Interval | Liters/seconds | | Baseline and week 2 | | | | ID | Title | Description |
|---|
| OG000 | Budesonide Hydrofluoroalkane(HFA) 100 | Budesonide Hydrofluoroalkane(HFA) 100 mcg twice daily for 2 weeks | | OG001 | Budesonide HFA 400 | Budesonide HFA 400 mcg twice daily for 2 weeks | | OG002 | Budesonide Chlorofluorocarbon (CFC) 100 | Budesonide Chlorofluorocarbon(CFC) 100 mcg twice daily for 2 weeks | | OG003 | Budesonide CFC 400 | Budesonide CFC 400 mcg twice daily for 2 weeks |
| |
| Secondary | eNO (Exhaled Nitrogen Oxide) | | Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler). | Posted | | Geometric Mean | 95% Confidence Interval | Ratio | | baseline and week 2 | | | | ID | Title | Description |
|---|
| OG000 | Budesonide Hydrofluoroalkane(HFA) 100 | Budesonide Hydrofluoroalkane(HFA) 100 mcg twice daily for 2 weeks | | OG001 | Budesonide HFA 400 | Budesonide HFA 400 mcg twice daily for 2 weeks | | OG002 | Budesonide Chlorofluorocarbon (CFC) 100 | Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks | | OG003 | Budesonide CFC 400 | Budesonide CFC 400 mcg twice daily for 2 weeks |
| |
| Secondary | Asthma Symptom Score Morning | Asthma Symptom score recorded daily in the morning: Scale: 0-3. 0 = None; no asthma symptoms. 1 = Mild symptoms; aware of asthma symptoms but easily tolerated. 2 = Moderate symptoms; asthma causing enough discomfort to cause problems with normal activities (or with sleep). 3 =Severe symptoms; unable to do normal activities. The average of means for values recorded daily in the morning is presented. | Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler). | Posted | | Least Squares Mean | 95% Confidence Interval | Units on a scale | | 2 weeks | | | | ID | Title | Description |
|---|
| OG000 | Budesonide Hydrofluoroalkane(HFA) 100 | Budesonide Hydrofluoroalkane(HFA) 100 mcg twice daily for 2 weeks | | OG001 | Budesonide HFA 400 | Budesonide HFA 400 mcg twice daily for 2 weeks | | OG002 | Budesonide Chlorofluorocarbon(CFC) 100 | Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks | | OG003 | Budesonide CFC 400 |
|
| Secondary | Asthma Symptom Score Evening | Asthma Symptom score recorded daily in the evening: Scale: 0-3. 0 = None; no asthma symptoms. 1 = Mild symptoms; aware of asthma symptoms but easily tolerated. 2 = Moderate symptoms; asthma causing enough discomfort to cause problems with normal activities (or with sleep). 3 =Severe symptoms; unable to do normal activities. The average of means for values recorded daily in the evening is presented. | Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler). | Posted | | Least Squares Mean | 95% Confidence Interval | Units on a scale | | 2 weeks | | | | ID | Title | Description |
|---|
| OG000 | Budesonide Hydrofluoroalkane(HFA) 100 | Budesonide Hydrofluoroalkane (HFA) 100 mcg twice daily for 2 weeks | | OG001 | Budesonide HFA 400 | Budesonide HFA 400 mcg twice daily for 2 weeks | | OG002 | Budesonide Chlorofluorocarbon (CFC) 100 | Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks | | OG003 | Budesonide CFC 400 |
|
| Secondary | Asthma Symptom Score Total | Asthma Symptom score recoded daily, Total. Scale: 0 - 3. 0 = None; no asthma symptoms. 1 = Mild symptoms; aware of asthma symptoms but easily tolerated. 2 = Moderate symptoms; asthma causing enough discomfort to cause problems with normal activities (or with sleep). 3 =Severe symptoms; unable to do normal activities. The average of means for values recorded daily is presented. | Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler). | Posted | | Least Squares Mean | 95% Confidence Interval | Units on a scale | | 2 weeks | | | | ID | Title | Description |
|---|
| OG000 | Budesonide Hydrofluoroalkane(HFA) 100 | Budesonide Hydrofluoroalkane (HFA) 100 mcg twice daily for 2 weeks | | OG001 | Budesonide HFA 400 | Budesonide HFA 400 mcg twice daily for 2 weeks | | OG002 | Budesonide Chlorofluorocarbon (CFC) 100 | Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks | | OG003 | Budesonide CFC 400 |
|
| Secondary | Rescue Medication Morning | The average of means for inhalations of rescue medication in the morning is presented. | Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler). | Posted | | Least Squares Mean | 95% Confidence Interval | Number of inhalations | | 2 weeks | | | | ID | Title | Description |
|---|
| OG000 | Budesonide Hydrofluoroalkane (HFA) 100 | Budesonide Hydrofluoroalkane(HFA) 100 mcg twice daily for 2 weeks | | OG001 | Budesonide HFA 400 | Budesonide HFA 400 mcg twice daily for 2 weeks | | OG002 | Budesonide Chlorofluorocarbon (CFC) 100 | Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks | | OG003 | Budesonide CFC 400 | Budesonide CFC 400 mcg twice daily for 2 weeks |
| |
| Secondary | Rescue Medication Evening | The average of means for inhalations of rescue medication in the evening is presented. | Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler). | Posted | | Least Squares Mean | 95% Confidence Interval | Number of inhalations | | 2 weeks | | | | ID | Title | Description |
|---|
| OG000 | Budesonide Hydrofluoroalkane(HFA) 100 | Budesonide Hydrofluoroalkane(HFA) 100 mcg twice daily for 2 weeks | | OG001 | Budesonide HFA 400 | Budesonide HFA 400 mcg twice daily for 2 weeks | | OG002 | Budesonide Chlorofluorocarbon (CFC) 100 | Budesonide Chlorofluorocarbon(CFC) 100 mcg twice daily for 2 weeks | | OG003 | Budesonide CFC 400 | Budesonide CFC 400 mcg twice daily for 2 weeks |
| |
| Secondary | Rescue Medication Total | The average of means for inhalations of rescue medication in morning and evening combined over a 24 hour period is presented. | Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler). | Posted | | Least Squares Mean | 95% Confidence Interval | Number of inhalations/24 hours | | 2 weeks | | | | ID | Title | Description |
|---|
| OG000 | Budesonide Hydrofluoroalkane (HFA) 100 | Budesonide Hydrofluoroalkane(HFA) 100 mcg twice daily for 2 weeks | | OG001 | Budesonide HFA 400 | Budesonide HFA 400 mcg twice daily for 2 weeks | | OG002 | Budesonide Chlorofluorocarbon(CFC) 100 | Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks | | OG003 | Budesonide CFC 400 | Budesonide CFC 400 mcg twice daily for 2 weeks |
| |
| Secondary | Peak Exploratory Flow (PEF) Morning | Peak Exploratory Flow (PEF) recorded daily in the morning | Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler). | Posted | | Least Squares Mean | 95% Confidence Interval | Liters/minutes | | 2 weeks | | | | ID | Title | Description |
|---|
| OG000 | Budesonide Hydrofluoroalkane (HFA) 100 | Budesonide Hydrofluoroalkane(HFA) 100 mcg twice daily for 2 weeks | | OG001 | Budesonide HFA 400 | Budesonide HFA 400 mcg twice daily for 2 weeks | | OG002 | Budesonide Chlorofluorocarbon (CFC) 100 | Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks | | OG003 | Budesonide CFC 400 | Budesonide CFC 400 mcg twice daily for 2 weeks |
| |