Budesonide/formoterol

The efficacy of BDA MDI administered as needed compared with AS MDI on severe asthma exacerbation risk over the 24 to 52 week treatment period.

Lung function was measured by spirometry. Spirometry assessments were completed 5 minutes before dosing, 30 minutes after dosing (baseline; 5 minutes before the exercise challenge), and then 5, 10, 15, 30, and 60 minutes after the exercise challenge. A reduction in FEV₁ was expected due to the effects of asthma and exercise on breathing and lung function. The percentage fall in FEV₁ was calculated based on the baseline value and maximum percentage fall value during the 60-minute assessment period.

The annual COPD exacerbation rate was analyzed and compared between two arms. Annual exacerbation rate for each subject is defined as number of exacerbations divided by duration of randomized treatment period in years. The annual COPD exacerbation rate of Symbicort group was compared with annual rate of Formoterol group. The rate ratio of Symbicort vs. Formoteroal was assessed by a negative binomial model. Exacerbations, that met the modified Anthonisen criteria and duration ≥2 days were classified as moderate and severe exacerbations. Moderate exacerbation: treatment of symptoms with systemic corticosteroids (≥3 days) and/or antibiotics. Severe exacerbation: symptoms that require hospitalization (including \>24 hours in ED/urgent care setting).

Descriptive statistics for post-dose FEV1 (L) by visit; Baseline defined as the last pre-dose value prior to 1st dose of randomized therapy. Trt Avg = Mean of all available valid values after randomization.

Descriptive statistics for predose FEV1(L) by visit; Baseline defined as the last pre-dose value prior to 1st dose of randomized therapy. Trt Avg = Mean of all available valid values after randomization.

The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group

Mean change from Baseline

Change from baseline

Change from baseline

Change from baseline

Change from baseline

Change from baseline

Change from baseline

Change from baseline

Change from baseline

Change from baseline

Change from baseline

Change from baseline

Change from baseline

Change from baseline

Change from baseline

Change from baseline

Change from baseline

Change from baseline

Change from baseline

Change from baseline

Change from baseline

Change from baseline

Change from baseline

Change from baseline

Change from baseline

Change from baseline

Change from baseline

Change from baseline

Change from baseline

Change in morning peak expiratory flow (mPEF) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)

Asthma exacerbation was defined as deterioration in asthma leading to oral glucocorticosteroid \[GCS\] treatment, hospitalization, or emergency room \[ER\] treatment.

Total number of adverse events

The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.

The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.

The mean AUC of QTcF (ECG interval measured from the beginning of the Q wave to the end of the T wave, corrected for heart rate using Fridericia's formula)was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.

The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.

The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.

Ratio between the value at the end of treatment and the value at start of treatment, including only patients with values at both baseline and end of treatment

Change in the Morning PEF from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomisation). No imputation of missing data was performed

An exacerbation was defined as symptomatic worsening requiring oral/systemic glucocorticoid therapy and/or emergency room visit and/or urgent care center visit and/or hospitalization.

Change from baseline (average of daily records over the 14 days of run-in) to the average of daily records over the treatment period of 12 weeks, with baseline value as covariate.

Number of COPD-related exacerbations per patient-treatment year. COPD-related exacerbation was defined as worsening COPD that required a course of oral steriods for treatment and/or hospitalization.

Rate of exacerbations per subject-year

AEs were defined as undesirable medical conditions or deteriorations of a pre-existing medical condition following/during exposure. All Serious AEs, AEs leading to withdrawal, Other relevant AE were recorded.

The peak expiratory flow rate is the maximal rate that a person can exhale during a short maximal expiratory effort after a full inspiration. Baseline was calculated using the mean of the data recorded during the last 7 days of the run-in period, and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.

FEV1

To determine and compare the systemic availability (Cmax) of budesonide and formoterol after single doses of Symbicort Aerosphere and Symbicort pMDI in participants 4 to less than 12 years of age with asthma.

To determine and compare the systemic availability (AUC0-6) of budesonide and formoterol after single doses of Symbicort Aerosphere and Symbicort pMDI in participants 4 to less than 12 years of age with asthma.