| Primary | Peak Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Within 4 Hours Post-dose Following 1 Week of Treatment | Peak change from baseline in FEV1 within 4 hours post-dose was defined as the maximum of the FEV1 assessments within 4 hours post-dosing at each visit minus baseline, provided that there were at least 2 non-missing values during the first 4 hours post dose. | Modified Intent-to-treat (mITT) Population included all patients who were randomized to treatment and received at least one dose of study treatment with post-baseline spirometry data from both treatment periods at Visits 4 and 6. Patients with data judged to be impacted by important protocol deviations were excluded. Patients discontinued and restarted due to the study having been put on hold for the COVID-19 pandemic used the instance of enrollment after they restarted. | Posted | | Least Squares Mean | 95% Confidence Interval | L | | baseline and 4 hours post dose after 1 week of treatment | | | | ID | Title | Description |
|---|
| OG000 | BFF MDI | Subject treated with Budesonide Formoterol Fumarate Metered Dose Inhalation | | OG001 | Symbicort Turbuhaler | Subject treated with Symbicort Turbuhaler |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0000.256(0.190 to 0.322)
- OG0010.274(0.208 to 0.340)
|
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | ANCOVA | | 0.3450 | | Mean Difference (Final Values) | -0.017 | Standard Error of the Mean | 0.0179 | 2-Sided | 95 | -0.054 | 0.020 | | | | | Other | | |
|
| Secondary | Area Under the Curve for Change From Baseline in FEV1 From Area Under the Curve 0 to 4 Hours (AUC0-4 h) Following 1 Week of Treatment | FEV1 AUC0-4 was calculated using the trapezoidal rule and was normalized by dividing by the time in hours from dosing to the last measurement included (typically 4 hours). | mITT Population included all patients who were randomized to treatment and received at least one dose of study treatment with post-baseline spirometry data from both treatment periods at Visits 4 and 6. Patients with data judged to be impacted by important protocol deviations were excluded. Patients discontinued and restarted due to the study having been put on hold for the COVID-19 pandemic used the instance of enrollment after they restarted. | Posted | | Least Squares Mean | 95% Confidence Interval | L | | baseline and 4 hours post dose after 1 week of treatment | | | | ID | Title | Description |
|---|
| OG000 | BFF MDI | Subject treated with Budesonide Formoterol Fumarate Metered Dose Inhalation | | OG001 | Symbicort Turbuhaler | Subject treated with Symbicort Turbuhaler |
| |
| Secondary | Change From Baseline in Pre-dose FEV1 Following 1 Week of Treatment | Change from baseline in pre-dose FEV1 following 1 week of treatment was defined as the 45-minute pre-dose value following 1 week of treatment minus baseline. | mITT Population included all patients who were randomized to treatment and received at least one dose of study treatment with post-baseline spirometry data from both treatment periods at Visits 4 and 6. Patients with data judged to be impacted by important protocol deviations were excluded. Patients discontinued and restarted due to the study having been put on hold for the COVID-19 pandemic used the instance of enrollment after they restarted. | Posted | | Least Squares Mean | 95% Confidence Interval | L | | baseline and after 1 week of treatment | | | | ID | Title | Description |
|---|
| OG000 | BFF MDI | Subject treated with Budesonide Formoterol Fumarate Metered Dose Inhalation | | OG001 | Symbicort Turbuhaler | Subject treated with Symbicort Turbuhaler |
| |
| Secondary | Change From Baseline in 2-hour Post-dose Inspiratory Capacity (IC) Following 1 Week of Treatment | Change from baseline in 2-hour post-dose IC following 1 week of treatment was defined as the 2-hour post-dose assessment of IC following 1 week of treatment minus baseline IC. | mITT Population included all patients who were randomized to treatment and received at least one dose of study treatment with post-baseline spirometry data from both treatment periods at Visits 4 and 6. Patients with data judged to be impacted by important protocol deviations were excluded. Patients discontinued and restarted due to the study having been put on hold for the COVID-19 pandemic used the instance of enrollment after they restarted. | Posted | | Least Squares Mean | 95% Confidence Interval | L | | baseline and 2 hours post dose after 1 week of treatment | | | | ID | Title | Description |
|---|
| OG000 | BFF MDI | Subject treated with Budesonide Formoterol Fumarate Metered Dose Inhalation | | OG001 | Symbicort Turbuhaler | Subject treated with Symbicort Turbuhaler |
| |
| Secondary | Change From Baseline in Pre-dose Peak Inspiratory Flow (PIF; InCheck Device Set to no Resistance) Following 1 Week of Treatment | Change from baseline in pre-dose PIF (InCheck device set to no resistance) following 1 week of treatment was defined as the pre-dose PIF (InCheck device set to no resistance) following 1 week of treatment minus baseline PIF. (The InCheck Inspiratory Flow Measurement Device is an inhalation airflow meter that may be set to various resistances similar to marketed inhaler products. For this measurement, the device was set to no resistance.) | mITT Population included all patients who were randomized to treatment and received at least one dose of study treatment with post-baseline spirometry data from both treatment periods at Visits 4 and 6. Patients with data judged to be impacted by important protocol deviations were excluded. Patients discontinued and restarted due to the study having been put on hold for the COVID-19 pandemic used the instance of enrollment after they restarted. | Posted | | Least Squares Mean | 95% Confidence Interval | L/min | | baseline and after 1 week of treatment | | | | ID | Title | Description |
|---|
| OG000 | BFF MDI | Subject treated with Budesonide Formoterol Fumarate Metered Dose Inhalation | | OG001 | Symbicort Turbuhaler | Subject treated with Symbicort Turbuhaler |
| |
| Secondary | Change From Baseline in Pre-dose PIF (Resistance Set Equal to Turbuhaler S) Following 1 Week of Treatment | Change from baseline in pre-dose PIF (resistance set equal to Turbuhaler S) following 1 week of treatment was defined as the pre-dose PIF (resistance set equal to Turbuhaler S) following 1 week of treatment minus baseline PIF. (The InCheck Inspiratory Flow Measurement Device is an inhalation airflow meter that may be set to various resistances similar to marketed inhaler products. For this measurement, the device was set to resistance equal to the product Turbuhaler S.) | mITT Population included all patients who were randomized to treatment and received at least one dose of study treatment with post-baseline spirometry data from both treatment periods at Visits 4 and 6. Patients with data judged to be impacted by important protocol deviations were excluded. Patients discontinued and restarted due to the study having been put on hold for the COVID-19 pandemic used the instance of enrollment after they restarted. | Posted | | Least Squares Mean | 95% Confidence Interval | L/min | | baseline and after 1 week of treatment | | | | ID | Title | Description |
|---|
| OG000 | BFF MDI | Subject treated with Budesonide Formoterol Fumarate Metered Dose Inhalation | | OG001 | Symbicort Turbuhaler | Subject treated with Symbicort Turbuhaler |
| |
| Secondary | Change From Baseline in Pre-dose PIF (Resistance Set Equal to ELLIPTA) Following 1 Week of Treatment | Change from baseline in pre-dose PIF (resistance set equal to ELLIPTA) following 1 week of treatment was defined as the pre-dose PIF (resistance set equal to ELLIPTA) following 1 week of treatment minus baseline PIF. (The InCheck Inspiratory Flow Measurement Device is an inhalation airflow meter that may be set to various resistances similar to marketed inhaler products. For this measurement, the device was set to resistance equal to the product ELLIPTA.) | mITT Population included all patients who were randomized to treatment and received at least one dose of study treatment with post-baseline spirometry data from both treatment periods at Visits 4 and 6. Patients with data judged to be impacted by important protocol deviations were excluded. Patients discontinued and restarted due to the study having been put on hold for the COVID-19 pandemic used the instance of enrollment after they restarted. | Posted | | Least Squares Mean | 95% Confidence Interval | L/min | | baseline and after 1 week of treatment | | | | ID | Title | Description |
|---|
| OG000 | BFF MDI | Subject treated with Budesonide Formoterol Fumarate Metered Dose Inhalation | | OG001 | Symbicort Turbuhaler | Subject treated with Symbicort Turbuhaler |
| |
| Secondary | Change From Baseline in 2-hour Post-dose FEV1 Following the First Dose | Change from baseline in 2-hour post-dose FEV1 following the 1st dose of treatment was defined as the 2-hour post-dose assessment of FEV1 following the 1st dose of treatment (Visit 3 or 5) minus baseline FEV1. | mITT Population included all patients who were randomized to treatment and received at least one dose of study treatment with post-baseline spirometry data from both treatment periods at Visits 4 and 6. Patients with data judged to be impacted by important protocol deviations were excluded. Patients discontinued and restarted due to the study having been put on hold for the COVID-19 pandemic used the instance of enrollment after they restarted. | Posted | | Least Squares Mean | 95% Confidence Interval | L | | baseline and 2 hours post dose after the first dose of treatment | | | | ID | Title | Description |
|---|
| OG000 | BFF MDI | Subject treated with Budesonide Formoterol Fumarate Metered Dose Inhalation | | OG001 | Symbicort Turbuhaler | Subject treated with Symbicort Turbuhaler |
| |
| Secondary | Change From Baseline in 2-hour Post-dose IC Following the First Dose | Change from baseline in 2-hour post-dose IC following the 1st dose of treatment was defined as the 2-hour post-dose assessment of IC following the 1st dose of treatment (Visit 3 or 5) minus baseline IC. | mITT Population included all patients who were randomized to treatment and received at least one dose of study treatment with post-baseline spirometry data from both treatment periods at Visits 4 and 6. Patients with data judged to be impacted by important protocol deviations were excluded. Patients discontinued and restarted due to the study having been put on hold for the COVID-19 pandemic used the instance of enrollment after they restarted. | Posted | | Least Squares Mean | 95% Confidence Interval | L | | baseline and 2 hours post dose after the first dose of treatment | | | | ID | Title | Description |
|---|
| OG000 | BFF MDI | Subject treated with Budesonide Formoterol Fumarate Metered Dose Inhalation | | OG001 | Symbicort Turbuhaler | Subject treated with Symbicort Turbuhaler |
| |