Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Proportion of participants who discontinued OCS without loss of asthma control |
Proportion of participants who discontinued OCS without loss of asthma control at Week 28. |
At Week 28 |
|
| Primary |
Proportion of participants who discontinued OCS without loss of asthma control |
Proportion of participants who discontinued OCS without loss of asthma control at Week 52. |
At Week 52 |
|
| Primary |
Proportion of participants who reduced daily prescribed maintenance OCS dose to = 5 mg/day without loss of asthma control |
Proportion of participants who reduced daily prescribed maintenance OCS dose to = 5 mg/day without loss of asthma control at Week 28. |
At Week 28 |
|
| Primary |
Proportion of participants who reduced daily prescribed maintenance OCS dose to = 5 mg/day without loss of asthma control |
Proportion of participants who reduced daily prescribed maintenance OCS dose to = 5 mg/day without loss of asthma control at Week 52. |
At Week 52 |
|
| Secondary |
The Annualised Asthma Exacerbation Rate |
The annualised asthma exacerbation rate is based on exacerbations reported by investigator in eCRF over 28 weeks. |
Baseline to Week 28 |
|
| Secondary |
The Annualised Asthma Exacerbation Rate |
The annualised asthma exacerbation rate is based on exacerbations reported by investigator in eCRF over 52 weeks. |
Baseline to Week 52 |
|
| Secondary |
Rate of asthma exacerbation associated with hospitalisation or emergency room (ER) |
Rate of asthma exacerbation is based on exacerbations reported by the investigator in eCRF that are associated with a hospitalization or an emergency room visit over 28 weeks. |
Baseline to Week 28 |
|
| Secondary |
Rate of asthma exacerbation associated with hospitalisation or emergency room (ER) |
Rate of asthma exacerbation is based on exacerbations reported by the investigator in eCRF that are associated with a hospitalization or an emergency room visit over 52 weeks. |
Baseline to Week 52 |
|
| Secondary |
Rate of asthma exacerbation associated with hospitalisation |
Rate of asthma exacerbation is based on exacerbations reported by the investigator in eCRF that are associated with a hospitalization over 28 weeks. |
Baseline to Week 28 |
|
| Secondary |
Rate of asthma exacerbation associated with hospitalisation |
Rate of asthma exacerbation is based on exacerbations reported by the investigator in eCRF that are associated with a hospitalization over 52 weeks. |
Baseline to Week 52 |
|
| Secondary |
Proportion of participants who did not experience an exacerbation |
Proportion of participants who did not experience an exacerbation over 28 weeks. |
Baseline to Week 28 |
|
| Secondary |
Proportion of participants who did not experience an exacerbation |
Proportion of participants who did not experience an exacerbation over 52 weeks. |
Baseline to Week 52 |
|
| Secondary |
Proportion of participants who did not experience an exacerbation associated with hospitalisation or ER visit |
Proportion of participants who did not experience an exacerbation associated with hospitalization or ER visit over 28 weeks. |
Baseline to Week 28 |
|
| Secondary |
Proportion of participants who did not experience an exacerbation associated with hospitalisation or ER visit |
Proportion of participants who did not experience an exacerbation associated with hospitalization or ER visit over 52 weeks. |
Baseline to Week 52 |
|
| Secondary |
Proportion of participants who did not experience an exacerbation associated with hospitalisation |
Proportion of participants who did not experience an exacerbation associated with hospitalization over 28 weeks. |
Baseline to Week 28 |
|
| Secondary |
Proportion of participants who did not experience an exacerbation associated with hospitalisation |
Proportion of participants who did not experience an exacerbation associated with hospitalization over 52 weeks. |
Baseline to Week 52 |
|
| Secondary |
Proportion of participants with = 50% reduction from baseline in daily maintenance OCS dose |
Proportion of participants with = 50% reduction from baseline in daily maintenance OCS dose at Week 28. Percent change from baseline is defined as {(final dose-baseline dose)/baseline dose}*100. |
Baseline to Week 28 |
|
| Secondary |
Proportion of participants with = 50% reduction from baseline in daily maintenance OCS dose |
Proportion of participants with = 50% reduction from baseline in daily maintenance OCS dose at Week 52. Percent change from baseline is defined as {(final dose-baseline dose)/baseline dose}*100. |
Baseline to Week 52 |
|
| Secondary |
Categorised percent reduction from baseline in the daily maintenance OCS dose |
Categorised percent reduction from baseline in the daily maintenance OCS dose at Week 28. Percent change from baseline is derived as {(final dose-baseline dose)/baseline dose}*100 and the categories of percent change from baseline are defined as = 90% to = 100% reduction, = 75% to < 90% reduction, = 50% to < 75% reduction, > 0% to < 50% reduction, no change or any increase. |
Baseline to Week 28 |
|
| Secondary |
Categorised percent reduction from baseline in the daily maintenance OCS dose |
Categorised percent reduction from baseline in the daily maintenance OCS dose at Week 52. Percent change from baseline is derived as {(final dose-baseline dose)/baseline dose}*100 and the categories of percent change from baseline are defined as = 90% to = 100% reduction, = 75% to < 90% reduction, = 50% to < 75% reduction, > 0% to < 50% reduction, no change or any increase. |
Baseline to Week 52 |
|
| Secondary |
Absolute and percent change from baseline in daily maintenance OCS dose |
Absolute and percent change from baseline in daily maintenance OCS dose at Week 28. Absolute change from baseline is defined as (final dose-baseline dose). Percent change from baseline is defined as {(final OCS dose-baseline OCS)/baseline OCS}*100. |
Baseline to Week 28 |
|
| Secondary |
Absolute and percent change from baseline in daily maintenance OCS dose |
Absolute and percent change from baseline in daily maintenance OCS dose at Week 52. Absolute change from baseline is defined as (final dose-baseline dose). Percent change from baseline is defined as {(final OCS dose-baseline OCS)/baseline OCS}*100. |
Baseline to Week 52 |
|
| Secondary |
Change from baseline in post-bronchodilator (post-BD) FEV1 |
Change from baseline in post-bronchodilator (post-BD) FEV1 at Week 28. FEV1 is defined as as the volume of air exhaled from the lungs in the first second of a forced expiration. |
Baseline to Week 28 |
|
| Secondary |
Change from baseline in post-bronchodilator (post-BD) FEV1 |
Change from baseline in post-bronchodilator (post-BD) FEV1 at Week 52. FEV1 is defined as as the volume of air exhaled from the lungs in the first second of a forced expiration. |
Baseline to Week 52 |
|
| Secondary |
Change from baseline in Asthma Control Questionnaire 6 (ACQ-6) score |
Change from baseline in Asthma Control Questionnaire 6 (ACQ-6) at Week 28. The ACQ-6 captures asthma symptoms and short-acting ß2 agonists use via subject-report. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The ACQ-6 score is the mean of the responses. |
Baseline to Week 28 |
|
| Secondary |
Change from baseline in Asthma Control Questionnaire 6 (ACQ-6) score |
Change from baseline in Asthma Control Questionnaire 6 (ACQ-6) at Week 52. The ACQ-6 captures asthma symptoms and short-acting ß2 agonists use via subject-report. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The ACQ-6 score is the mean of the responses. |
Baseline to Week 52 |
|
| Secondary |
Change from baseline in standardised Asthma Quality of Life Questionnaire for 12 years and older (AQLQ[s]+12) total score |
Change from baseline in standardised Asthma Quality of Life Questionnaire for 12 years and older (AQLQ[s]+12) total score at Week 28. The AQLQ[s]+12 is a questionnaire that measured the health-related quality of life experienced by asthma subjects. The total score is defined as the average of all 32 questions in the AQLQ[s]+12 questionnaire. AQLQ[s]+12 is 7 point scale questionnaire, ranging from 7 (no impairment) to 1 (severe impairment). The total score is the mean of the responses. |
Baseline to Week 28 |
|
| Secondary |
Change from baseline in standardised Asthma Quality of Life Questionnaire for 12 years and older (AQLQ[s]+12) total score |
Change from baseline in standardised Asthma Quality of Life Questionnaire for 12 years and older (AQLQ[s]+12) total score at Week 52. The AQLQ[s]+12 is a questionnaire that measured the health-related quality of life experienced by asthma subjects. The total score is defined as the average of all 32 questions in the AQLQ[s]+12 questionnaire. AQLQ[s]+12 is 7 point scale questionnaire, ranging from 7 (no impairment) to 1 (severe impairment). The total score is the mean of the responses. |
Baseline to Week 52 |
|
| Secondary |
Change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score |
Change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score at Week 28. The SGRQ is a questionnaire that measures health status of participants with airway obstruction diseases. The total score is expressed as a percentage of overall impairment, where 100 represents the worst possible health status and 0 indicates the best possible health status. |
Baseline to Week 28 |
|
| Secondary |
Change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score |
Change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score at Week 52. The SGRQ is a questionnaire that measures health status of participants with airway obstruction diseases. The total score is expressed as a percentage of overall impairment, where 100 represents the worst possible health status and 0 indicates the best possible health status. |
Baseline to Week 52 |
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