Asthma
Conditions
Brief summary
This is a randomized, double-blind, multicenter, parallel-group, variable-length study to compare 2 doses of BDA MDI (PT027) with AS MDI (PT007) on the time to first severe asthma exacerbation in adult, adolescent, and pediatric subjects with moderate to severe asthma.
Interventions
COMBINATION_PRODUCTBudesonide/albuterol sulfate metered-dose inhaler 160/180 μg
Budesonide/albuterol sulfate combination inhalation aerosol
COMBINATION_PRODUCTBudesonide/albuterol sulfate metered-dose inhaler 80/180 μg
Budesonide/albuterol sulfate combination inhalation aerosol
DRUGAlbuterol sulfate metered-dose inhaler 180 μg
Albuterol sulfate inhalation aerosol
Sponsors
Bond Avillion 2 Development LP
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Female or male aged ≥4 years at the time of informed consent 2. Physician diagnosis of asthma documented for at least 1 year 3. Receiving 1 of the following scheduled asthma maintenance therapies for 3 months with stable dosing for at least the last 4 weeks before Visit 1: * Medium-to-high-dose inhaled corticosteroid (ICS) * Medium-to-high-dose ICS and 1 additional maintenance therapy from the following: leukotriene receptor antagonists (LTRA), long-acting muscarinic antagonists (LAMA), or theophylline * Low-to-high-dose ICS in combination with long-acting β2-adrenoreceptor agonist (LABA) with or without one additional maintenance therapy from the following: LTRA, LAMA, or theophylline 4. Prebronchodilator forced expiratory volume in 1 second (FEV1) of ≥40 to \<90% predicted normal value for adults and adolescents, and ≥60 to \<100% predicted normal value for subjects aged 4 to 11 years after withholding specified medications including short/rapid-acting β2-adrenoreceptor agonist (SABA) 5. Demonstrate reversibility at Visit 1, with an increase in FEV1 ≥12% (and ≥200 mL for subjects aged ≥18 years) relative to baseline after administration of sponsor provided Ventolin via central spirometry. One re-test for reversibility testing is allowed within the screening period in advance of Visit 2 6. Demonstrate acceptable spirometry performance (i.e., meet American Thoracic Society/European Respiratory Society acceptability/repeatability criteria) 7. A documented history of at least 1 severe asthma exacerbation within 12 months before Visit 1 8. Able to perform acceptable and reproducible peak expiratory flow (PEF) measurements as assessed by the investigator
Exclusion criteria
1. Chronic obstructive pulmonary disease or other significant lung disease (e.g., chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, or bronchopulmonary dysplasia) 2. Oral corticosteroid/SCS use (any dose and any indication) within 6 weeks before Visit 1 3. Chronic use of oral corticosteroids (OCS, ≥3 weeks use in 3 months prior to Visit 1) 4. Having received any marketed (e.g., omalizumab, mepolizumab, reslizumab, benralizumab) or investigational biologic within 3 months or any other prohibited medication 5. Current smokers, former smokers with \>10 pack-years history, or former smokers who stopped smoking \<6 months before Visit 1 (including all forms of tobacco, e-cigarettes \[vaping\], and marijuana) 6. Life-threatening asthma defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma related syncopal episode(s) within 5 years of Visit 1 7. Historical or current evidence of a clinically significant disease 8. Cancer not in complete remission for at least 5 years 9. Hospitalization for psychiatric disorder or attempted suicide within 1 year of Visit 1 10. History of psychiatric disease, intellectual deficiency, poor motivation, or other conditions if their magnitude is limiting informed consent validity 11. Significant abuse of alcohol or drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Severe Asthma Exacerbation Event | From randomization up to a discontinuation of randomized treatment or a change in maintenance therapy. The mean and median reporting period for all participants was 44 and 48 weeks, respectively. | Time to first severe asthma exacerbation will be calculated as the time from randomization until the start date of the first severe asthma exacerbation. An asthma exacerbation will be considered severe if it results in at least one of the following: a temporary bolus/burst of systemic corticosteroids for at least 3 consecutive days to treat symptoms of asthma worsening (a single depo-injectable dose of corticosteroids will be considered equivalent), an emergency room or urgent care visit (\<24 hours in the facility for evaluation and treatment) due to asthma that required systemic corticosteroids, or an in-patient hospitalization (admission to an in-patient facility and/or ≥ 24 hours in a healthcare facility) due to asthma. The descriptive summary shows the number of participants with a severe exacerbation event, occurring between the date of randomization up to the date of randomized treatment discontinuation or a change in maintenance therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Annualized Severe Exacerbation Rate | From randomization up to discontinuation of randomized treatment or a change in maintenance therapy. The mean and median reporting period for all participants was 44 and 48 weeks, respectively. | The annualized severe exacerbation rate (severe exacerbations per year) is estimated from a negative binomial model with treatment, age group, region, and number of severe exacerbations in the last 12 months prior to randomization as categorical covariates. The logarithm of the time at risk is included as an offset variable. |
| Total Annualized Dose of Systemic Corticosteroid (SCS) | From randomization up to discontinuation of randomized treatment or a change in maintenance therapy. The mean and median reporting period for all participants was 44 and 48 weeks, respectively. | This endpoint includes all systemic corticosteroids (SCS) taken in response to a severe exacerbation event from randomization up to randomized treatment discontinuation or a change in maintenance therapy. All SCS are standardized to equipotent doses of prednisone before deriving the total dose. The total annualized dose is calculated as the total dose of SCS divided by the duration of the randomized treatment period. |
| Asthma Control Questionnaire-5 (ACQ-5) - Number of Participants Who Were Responders at Week 24 | From baseline to Week 24 | The ACQ-5 consists of 5 questions on symptom control, with each scored on a 7-point scale (0 = excellent asthma control; 6 = extremely poor control). The overall score (0 = excellent asthma control; 6 = extremely poor control, so a lower score is the better outcome) is the mean of the 5 symptom items. A responder is defined as a participant with a decrease from baseline to Week 24 overall ACQ-5 score of 0.5 or more. ACQ-5 is not validated for children less than 6 years old, data for participants who were 4 or 5 years old was excluded from the analysis of ACQ-5. |
| Asthma Quality of Life Questionnaire for Participants Aged 12 Years and Older (AQLQ+12) - Number of Participants Who Were Responders at Week 24 | From baseline to 24 weeks | The AQLQ+12 consists of 32 questions in 4 domains and is assessed on separate 7-point Likert scales from 1 to 7, with higher values indicating better health-related quality of life. The overall score is the mean of all responses. A responder is defined as a participant with an increase from baseline to week 24 AQLQ-12 score of at least 0.5. |
Countries
Argentina, Canada, Czechia, Germany, Serbia, Slovakia, South Africa, Spain, Ukraine, United Kingdom, United States
Participant flow
Recruitment details
The first subject enrolled on 13 December 2018 and the last subject completed the study on 07 February 2022. Subjects were enrolled at 347 study centers worldwide (Argentina, Canada, Czechia, Germany, Serbia, Slovakia, South Africa, Spain, Ukraine, United Kingdom and the United States).
Pre-assignment details
The randomized treatment phase started after a 2 to 4 week screening period during which participants used sponsor provided Ventolin HFA (albuterol sulfate) as needed. In addition to the 3,132 participants randomized, 2,488 participants were screened but did not participate, of which 2,456 were ineligible (98.7%). The next most frequent reason was withdrawal by the participant, with 18 meeting this criteria.
Participants by arm
| Arm | Count |
|---|---|
| BDA MDI (PT027) 160/180 μg Budesonide/albuterol sulfate, BDA MDI, PT027 high dose
Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg: Budesonide/albuterol sulfate combination inhalation aerosol | 1,015 |
| BDA MDI (PT027) 80/180 μg Budesonide/albuterol sulfate, BDA MDI, PT027 low dose
Budesonide/albuterol sulfate metered-dose inhaler 80/180 μg: Budesonide/albuterol sulfate combination inhalation aerosol | 1,055 |
| AS MDI (PT007) 180 µg Albuterol sulfate MDI, PT007
Albuterol sulfate metered-dose inhaler 180 μg: Albuterol sulfate inhalation aerosol | 1,057 |
| Total | 3,127 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | >= 3 severe exacerbation events within a 3 month period | 1 | 4 | 4 |
| Overall Study | >= 5 total severe exacerbation events | 0 | 1 | 1 |
| Overall Study | Adverse Event | 7 | 7 | 8 |
| Overall Study | A single severe exacerbation event lasting >20 days | 0 | 1 | 2 |
| Overall Study | Condition under investigation worsened | 2 | 0 | 1 |
| Overall Study | Death | 4 | 2 | 2 |
| Overall Study | Lack of Efficacy | 1 | 2 | 2 |
| Overall Study | Lost to Follow-up | 19 | 25 | 21 |
| Overall Study | Other reasons | 8 | 12 | 15 |
| Overall Study | Pregnancy | 1 | 0 | 3 |
| Overall Study | Protocol Violation | 5 | 6 | 8 |
| Overall Study | Randomized and did not receive randomized study treatment | 1 | 2 | 2 |
| Overall Study | Withdrawal by Subject | 52 | 62 | 74 |
Baseline characteristics
| Characteristic | BDA MDI (PT027) 160/180 μg | BDA MDI (PT027) 80/180 μg | AS MDI (PT007) 180 µg | Total |
|---|---|---|---|---|
| Age, Continuous | 50.6 years STANDARD_DEVIATION 15.05 | 48.5 years STANDARD_DEVIATION 16.71 | 49.1 years STANDARD_DEVIATION 17.22 | 49.4 years STANDARD_DEVIATION 16.39 |
| Age, Customized Adolescents (>=12 to <18 years) | 34 Participants | 32 Participants | 34 Participants | 100 Participants |
| Age, Customized Adults (>=18 to <65 years) | 789 Participants | 805 Participants | 784 Participants | 2378 Participants |
| Age, Customized Children (>=4 to <12 years) | 0 Participants | 41 Participants | 42 Participants | 83 Participants |
| Age, Customized Elderly (>=65 years) | 192 Participants | 177 Participants | 197 Participants | 566 Participants |
| Body mass index | 28.887 kg/m^2 STANDARD_DEVIATION 5.4002 | 28.496 kg/m^2 STANDARD_DEVIATION 5.5886 | 28.948 kg/m^2 STANDARD_DEVIATION 5.6271 | 28.776 kg/m^2 STANDARD_DEVIATION 5.5432 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 235 Participants | 261 Participants | 316 Participants | 812 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 780 Participants | 794 Participants | 741 Participants | 2315 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Height | 166.8 Centimeters STANDARD_DEVIATION 9.92 | 165.1 Centimeters STANDARD_DEVIATION 11.45 | 164.4 Centimeters STANDARD_DEVIATION 11.67 | 165.4 Centimeters STANDARD_DEVIATION 11.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 29 Participants | 33 Participants | 23 Participants | 85 Participants |
| Race (NIH/OMB) Black or African American | 139 Participants | 141 Participants | 137 Participants | 417 Participants |
| Race (NIH/OMB) More than one race | 18 Participants | 20 Participants | 24 Participants | 62 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 12 Participants | 4 Participants | 24 Participants |
| Race (NIH/OMB) White | 820 Participants | 848 Participants | 869 Participants | 2537 Participants |
| Region of Enrollment Argentina | 157 Participants | 200 Participants | 207 Participants | 564 Participants |
| Region of Enrollment Canada | 19 Participants | 11 Participants | 12 Participants | 42 Participants |
| Region of Enrollment Czechia | 74 Participants | 64 Participants | 73 Participants | 211 Participants |
| Region of Enrollment Germany | 109 Participants | 108 Participants | 112 Participants | 329 Participants |
| Region of Enrollment Serbia | 65 Participants | 54 Participants | 57 Participants | 176 Participants |
| Region of Enrollment Slovakia | 25 Participants | 30 Participants | 28 Participants | 83 Participants |
| Region of Enrollment South Africa | 106 Participants | 120 Participants | 115 Participants | 341 Participants |
| Region of Enrollment Spain | 21 Participants | 28 Participants | 25 Participants | 74 Participants |
| Region of Enrollment Ukraine | 156 Participants | 150 Participants | 128 Participants | 434 Participants |
| Region of Enrollment United Kingdom | 9 Participants | 15 Participants | 10 Participants | 34 Participants |
| Region of Enrollment United States | 274 Participants | 275 Participants | 290 Participants | 839 Participants |
| Sex: Female, Male Female | 647 Participants | 686 Participants | 695 Participants | 2028 Participants |
| Sex: Female, Male Male | 368 Participants | 369 Participants | 362 Participants | 1099 Participants |
| Weight | 80.5 Kilograms STANDARD_DEVIATION 16.88 | 78.2 Kilograms STANDARD_DEVIATION 18.93 | 78.8 Kilograms STANDARD_DEVIATION 18.47 | 79.2 Kilograms STANDARD_DEVIATION 18.15 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 4 / 1,015 | 2 / 1,055 | 2 / 1,057 |
| other Total, other adverse events | 244 / 1,015 | 253 / 1,055 | 243 / 1,057 |
| serious Total, serious adverse events | 53 / 1,015 | 40 / 1,055 | 48 / 1,057 |
Outcome results
Primary
Number of Participants With a Severe Asthma Exacerbation Event
Time to first severe asthma exacerbation will be calculated as the time from randomization until the start date of the first severe asthma exacerbation. An asthma exacerbation will be considered severe if it results in at least one of the following: a temporary bolus/burst of systemic corticosteroids for at least 3 consecutive days to treat symptoms of asthma worsening (a single depo-injectable dose of corticosteroids will be considered equivalent), an emergency room or urgent care visit (\<24 hours in the facility for evaluation and treatment) due to asthma that required systemic corticosteroids, or an in-patient hospitalization (admission to an in-patient facility and/or ≥ 24 hours in a healthcare facility) due to asthma. The descriptive summary shows the number of participants with a severe exacerbation event, occurring between the date of randomization up to the date of randomized treatment discontinuation or a change in maintenance therapy.
Time frame: From randomization up to a discontinuation of randomized treatment or a change in maintenance therapy. The mean and median reporting period for all participants was 44 and 48 weeks, respectively.
Population: All participants that were randomized, took at least one puff of randomized treatment, and had at least one efficacy assessment, excluding participants confirmed as duplicates (n = 4). As children \<12 years of age were not randomized to the BDA MDI 160/180μg dose, comparison was made to the participants \>=12 years of age within the AS MDI 180μg arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BDA MDI 160/180 μg (Full Analysis Set; >=12 Years) | Number of Participants With a Severe Asthma Exacerbation Event | 207 Participants |
| AS MDI 180 μg (Full Analysis Set; >=12 Years) | Number of Participants With a Severe Asthma Exacerbation Event | 266 Participants |
| BDA MDI 80/180 μg (Full Analysis Set) | Number of Participants With a Severe Asthma Exacerbation Event | 241 Participants |
| AS MDI 180 μg (Full Analysis Set) | Number of Participants With a Severe Asthma Exacerbation Event | 276 Participants |
Comparison: H0 = null hypothesis. Hazard ratios, 95% confidence intervals for hazard ratios and p-values are estimated using a Cox regression model with treatment group, age group, region and number of severe exacerbations in the last 12 months prior to randomization as factors. A hazard ratio less than 1 favours BDA MDI treatment.p-value: <0.00195% CI: [0.611, 0.879]Regression, Cox
Comparison: H0 = Null hypothesis. Hazard ratios, 95% confidence intervals for hazard ratios and p-values are estimated using a Cox regression model with treatment group, age group, region and number of severe exacerbations in the last 12 months prior to randomization as factors. A hazard ratio less than 1 favours BDI MDI treatment.p-value: 0.04195% CI: [0.702, 0.992]Regression, Cox
Secondary
Annualized Severe Exacerbation Rate
The annualized severe exacerbation rate (severe exacerbations per year) is estimated from a negative binomial model with treatment, age group, region, and number of severe exacerbations in the last 12 months prior to randomization as categorical covariates. The logarithm of the time at risk is included as an offset variable.
Time frame: From randomization up to discontinuation of randomized treatment or a change in maintenance therapy. The mean and median reporting period for all participants was 44 and 48 weeks, respectively.
Population: All participants that were randomized, took at least one puff of randomized treatment, and had at least one efficacy assessment, excluding participants confirmed as duplicates (n = 4). As children \<12 years of age were not randomized to the BDA MDI 160/180μg dose, comparison was made to the participants \>=12 years of age within the AS MDI 180μg arm.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| BDA MDI 160/180 μg (Full Analysis Set; >=12 Years) | Annualized Severe Exacerbation Rate | 0.45 Severe exacerbations per year |
| AS MDI 180 μg (Full Analysis Set; >=12 Years) | Annualized Severe Exacerbation Rate | 0.59 Severe exacerbations per year |
| BDA MDI 80/180 μg (Full Analysis Set) | Annualized Severe Exacerbation Rate | 0.49 Severe exacerbations per year |
| AS MDI 180 μg (Full Analysis Set) | Annualized Severe Exacerbation Rate | 0.61 Severe exacerbations per year |
Comparison: Estimated from a negative binomial model with treatment, age group, region, and number of severe exacerbations in the last 12 months prior to randomization as categorical covariates. The logarithm of the time at risk is included as an offset variable. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.p-value: 0.00895% CI: [0.62, 0.93]Negative binomial model
Comparison: Estimated from a negative binomial model with treatment, age group, region, and number of severe exacerbations in the last 12 months prior to randomization as categorical covariates. The logarithm of the time at risk is included as an offset variable. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.p-value: 0.02895% CI: [0.66, 0.98]Negative binomial model
Secondary
Asthma Control Questionnaire-5 (ACQ-5) - Number of Participants Who Were Responders at Week 24
The ACQ-5 consists of 5 questions on symptom control, with each scored on a 7-point scale (0 = excellent asthma control; 6 = extremely poor control). The overall score (0 = excellent asthma control; 6 = extremely poor control, so a lower score is the better outcome) is the mean of the 5 symptom items. A responder is defined as a participant with a decrease from baseline to Week 24 overall ACQ-5 score of 0.5 or more. ACQ-5 is not validated for children less than 6 years old, data for participants who were 4 or 5 years old was excluded from the analysis of ACQ-5.
Time frame: From baseline to Week 24
Population: All participants that were randomized, took at least one puff of randomized treatment, and had at least one efficacy assessment, excluding participants confirmed as duplicates (n = 4). As children \<12 years of age were not randomized to the BDA MDI 160/180μg dose, comparison was made to the participants \>=12 years of age within the AS MDI 180μg arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BDA MDI 160/180 μg (Full Analysis Set; >=12 Years) | Asthma Control Questionnaire-5 (ACQ-5) - Number of Participants Who Were Responders at Week 24 | 677 Participants |
| AS MDI 180 μg (Full Analysis Set; >=12 Years) | Asthma Control Questionnaire-5 (ACQ-5) - Number of Participants Who Were Responders at Week 24 | 630 Participants |
| BDA MDI 80/180 μg (Full Analysis Set) | Asthma Control Questionnaire-5 (ACQ-5) - Number of Participants Who Were Responders at Week 24 | 681 Participants |
| AS MDI 180 μg (Full Analysis Set) | Asthma Control Questionnaire-5 (ACQ-5) - Number of Participants Who Were Responders at Week 24 | 650 Participants |
Comparison: Logistic regression model with baseline ACQ-5 as a continuous covariate and age group, region and number of severe exacerbations in the 12 months prior to randomization as categorical covariates. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.p-value: 0.03395% CI: [1.016, 1.467]Regression, Logistic
Comparison: Logistic regression model with baseline ACQ-5 as a continuous covariate and age group, region and number of severe exacerbations in the 12 months prior to randomization as categorical covariates. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.p-value: 0.17595% CI: [0.946, 1.353]Regression, Logistic
Secondary
Asthma Quality of Life Questionnaire for Participants Aged 12 Years and Older (AQLQ+12) - Number of Participants Who Were Responders at Week 24
The AQLQ+12 consists of 32 questions in 4 domains and is assessed on separate 7-point Likert scales from 1 to 7, with higher values indicating better health-related quality of life. The overall score is the mean of all responses. A responder is defined as a participant with an increase from baseline to week 24 AQLQ-12 score of at least 0.5.
Time frame: From baseline to 24 weeks
Population: All participants that were randomized, took at least one puff of randomized treatment, and had at least one efficacy assessment, excluding participants confirmed as duplicates (n = 4). As children \<12 years of age were not randomized to the BDA MDI 160/180μg dose, comparison was made to the participants \>=12 years of age within the AS MDI 180μg arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BDA MDI 160/180 μg (Full Analysis Set; >=12 Years) | Asthma Quality of Life Questionnaire for Participants Aged 12 Years and Older (AQLQ+12) - Number of Participants Who Were Responders at Week 24 | 508 Participants |
| AS MDI 180 μg (Full Analysis Set; >=12 Years) | Asthma Quality of Life Questionnaire for Participants Aged 12 Years and Older (AQLQ+12) - Number of Participants Who Were Responders at Week 24 | 489 Participants |
| BDA MDI 80/180 μg (Full Analysis Set) | Asthma Quality of Life Questionnaire for Participants Aged 12 Years and Older (AQLQ+12) - Number of Participants Who Were Responders at Week 24 | 461 Participants |
Comparison: Logistic regression model with baseline AQLQ-12 as a continuous covariate and age group, region and number of severe exacerbations in the 12 months prior to randomization as categorical covariates. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.p-value: 0.02895% CI: [1.022, 1.475]Regression, Logistic
Comparison: Logistic regression model with baseline AQLQ-12 as a continuous covariate and age group, region and number of severe exacerbations in the 12 months prior to randomization as categorical covariates. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.p-value: 0.2695% CI: [0.925, 1.335]Regression, Logistic
Secondary
Total Annualized Dose of Systemic Corticosteroid (SCS)
This endpoint includes all systemic corticosteroids (SCS) taken in response to a severe exacerbation event from randomization up to randomized treatment discontinuation or a change in maintenance therapy. All SCS are standardized to equipotent doses of prednisone before deriving the total dose. The total annualized dose is calculated as the total dose of SCS divided by the duration of the randomized treatment period.
Time frame: From randomization up to discontinuation of randomized treatment or a change in maintenance therapy. The mean and median reporting period for all participants was 44 and 48 weeks, respectively.
Population: All participants that were randomized, took at least one puff of randomized treatment, and had at least one efficacy assessment, excluding participants confirmed as duplicates (n = 4). As children \<12 years of age were not randomized to the BDA MDI 160/180μg dose, comparison was made to the participants \>=12 years of age within the AS MDI 180μg arm.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| BDA MDI 160/180 μg (Full Analysis Set; >=12 Years) | Total Annualized Dose of Systemic Corticosteroid (SCS) | 86.2 Milligram(s) |
| AS MDI 180 μg (Full Analysis Set; >=12 Years) | Total Annualized Dose of Systemic Corticosteroid (SCS) | 129.3 Milligram(s) |
| BDA MDI 80/180 μg (Full Analysis Set) | Total Annualized Dose of Systemic Corticosteroid (SCS) | 95.5 Milligram(s) |
| AS MDI 180 μg (Full Analysis Set) | Total Annualized Dose of Systemic Corticosteroid (SCS) | 127.1 Milligram(s) |
Comparison: P-values are calculated via a Wilcoxon rank sum test. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.p-value: 0.002Wilcoxon rank sum
Comparison: P-values are calculated via a Wilcoxon rank sum test. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.p-value: 0.06Wilcoxon rank sum