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.

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.

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.

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.

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.

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.

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.

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.

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.

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.