| Primary | Stage 1: Percentage of Participants Achieving Device Mastery | Device mastery was defined as absence of healthcare professional (HCP)-observed errors by the end of Step 3 of a 6-step standardized device training protocol for empty Spiromax compared to empty Turbohaler. The 6 steps of device training protocol were: Step 1 - Intuitive use; Step 2 - Patient information leaflet; Step 3 - Instructional video; Step 4 - HCP tuition; Step 5 - HCP tuition (1st repeat); Step 6 - HCP tuition (2nd repeat). | Full analysis set (FAS) for Stage 1 included all randomized participants who completed assessments on both study devices (empty Turbohaler and empty Spiromax), permitting a paired analysis of results. | Posted | | Number | | percentage of participants | | Baseline (Day 1) | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: Empty Spiromax | Participants were trained on the proper use of empty Spiromax. | | OG001 | Stage 1: Empty Turbohaler | Participants were trained on the proper use of empty Turbohaler. |
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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 |
|---|
| Analysis was performed using a conditional logistic regression model. | Chi-squared | | <0.001 | Threshold for significance at 0.05 level. | Odds Ratio (OR) | 3.77 | | | 2-Sided | 95 | 2.05 | 6.95 | | | | | Other | | |
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| Primary | Stage 2: Percentage of Participants Maintaining Device Mastery | Maintenance of device mastery was defined as absence of HCP-observed errors after 12 weeks of device use. | FAS for Stage 2 included all randomized participants who returned for assessment of maintenance of inhaler technique at Week 12, and who had at least 10 weeks (inclusive) of device use of the inhaler (treatment) to which they were randomly assigned. | Posted | | Number | | percentage of participants | | Baseline up to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: BF Spiromax | Participants who had currently received 800 to 1000 μg beclomethasone-equivalent ICS per day received budesonide/formoterol twice daily using the BF Spiromax 160/4.5 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using BF Spiromax were 640 μg and 18 μg, respectively. Participants who had currently received 1600 to 2000 μg beclomethasone-equivalent ICS per day received budesonide/formoterol twice daily using the BF Spiromax 320/9 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using BF Spiromax were 1280 μg and 36 μg, respectively. | | OG001 | Stage 2: Symbicort Turbohaler | Participants who had currently received 800 to 1000 μg beclomethasone-equivalent ICS per day received budesonide/formoterol twice daily using the Symbicort Turbohaler 200/6 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using Symbicort Turbohaler were 800 μg and 24 μg respectively. Participants who had currently received 1600 to 2000 μg beclomethasone-equivalent ICS per day received budesonide/formoterol twice daily using the Symbicort Turbohaler 400/12 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using Symbicort Turbohaler were 1600 μg and 48 μg respectively. |
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| Secondary | Stage 1: Percentage of Participants Achieving Device Mastery by Step 1 | The number of participants achieving device mastery by Step 1 (no training/intuitive use) of the device training process. Device mastery was defined as the absence of nurse-observed errors by the end of Step 3 of a 6-step standardized device training protocol for each device. The 6 training steps were as follows: Step 1, intuitive use; Step 2, patient device information leaflet; Step 3, instructional video; Step 4, nurse tuition; Step 5, nurse tuition (1st repeat); Step 6, nurse tuition (2nd repeat). After each training step an assessment of device use was carried out by the nurse using a pre-defined list of inhaler errors. | FAS for Stage 1 included all randomized participants who completed assessments on both study devices (empty Turbohaler and empty Spiromax), permitting a paired analysis of results. | Posted | | Number | | Percentage of participants | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: Empty Spiromax | Participants were trained on the proper use of empty Spiromax. | | OG001 | Stage 1: Empty Turbohaler | Participants were trained on the proper use of empty Turbohaler. |
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| Secondary | Stage 1: Percentage of Participants Achieving Device Mastery by Step 2 | The number of participants achieving device mastery by Step 2 (patient device information leaflet) of the device training process. Device mastery was defined as the absence of nurse-observed errors by the end of Step 3 of a 6-step standardized device training protocol for each device. The 6 training steps were as follows: Step 1, intuitive use; Step 2, patient device information leaflet; Step 3, instructional video; Step 4, nurse tuition; Step 5, nurse tuition (1st repeat); Step 6, nurse tuition (2nd repeat). After each training step an assessment of device use was carried out by the nurse using a pre-defined list of inhaler errors. | FAS for Stage 1 included all randomized participants who completed assessments on both study devices (empty Turbohaler and empty Spiromax), permitting a paired analysis of results. | Posted | | Number | | Percentage of participants | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: Empty Spiromax | Participants were trained on the proper use of empty Spiromax. | | OG001 | Stage 1: Empty Turbohaler | Participants were trained on the proper use of empty Turbohaler. |
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| Secondary | Stage 1: Number of Steps Taken to Achieve Device Mastery | | FAS for Stage 1 included all randomized participants who completed assessments on both study devices (empty Turbohaler and empty Spiromax), permitting a paired analysis of results. | Posted | | Median | Full Range | steps | | Baseline (Day 1) | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: Empty Spiromax | Participants were trained on the proper use of empty Spiromax. | | OG001 | Stage 1: Empty Turbohaler | Participants were trained on the proper use of empty Turbohaler. |
| |
| Secondary | Stage 1: Number of Nurse-Observed Errors | | FAS for Stage 1 included all randomized participants who completed assessments on both study devices (empty Turbohaler and empty Spiromax), permitting a paired analysis of results. | Posted | | Mean | Standard Deviation | Errors | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: Empty Spiromax | Participants were trained on the proper use of empty Spiromax. | | OG001 | Stage 1: Empty Turbohaler | Participants were trained on the proper use of empty Turbohaler. |
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| Secondary | Stage 1: Patient Satisfaction and Preference Questionnaire (PASAPQ) Total Score | The PASAPQ is a multi-item measure of inhalation device satisfaction and preference designed specifically for participants with asthma and chronic obstructive pulmonary disease. The PASAPQ includes a total of 14 device satisfaction items, including an overall satisfaction item. The total score was the sum of the 13 items related to performance and convenience domains (7 items for performance domain: Questions 1-5, 10-11, and 6 items for convenience domain: Questions 6-9, 12-13). Each PASAPQ item had response options ranging from 1 (very dissatisfied) to 7 (very satisfied). To calculate the total score, the items within each domain were first summed and then transformed to a 0 (least) or 100 (most) point scale, with higher scores indicating greater satisfaction. | FAS for Stage 1 included all randomized participants who completed assessments on both study devices (empty Turbohaler and empty Spiromax), permitting a paired analysis of results. Here 'overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | | Median | Full Range | units on a scale | | Baseline (Day 1) | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: Empty Spiromax | Participants were trained on the proper use of empty Spiromax. | | OG001 | Stage 1: Empty Turbohaler | Participants were trained on the proper use of empty turbohaler. |
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| Secondary | Composite Endpoint: Stage 2: Total Number of Observed Errors (Nurse and Technology [Vitalograph Pneumotrac Spirometer]) | Composite score calculated as the sum of nurse observed errors and technology-observed errors. | FAS for Stage 2 included all randomized participants who returned for assessment of maintenance of inhaler technique at Week 12, and who had at least 10 weeks (inclusive) of device use of the inhaler (treatment) to which they were randomly assigned. | Posted | | Mean | Standard Deviation | errors | | Baseline up to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: BF Spiromax | Participants who had currently received 800 to 1000 μg beclomethasone-equivalent ICS per day received budesonide/formoterol twice daily using the BF Spiromax 160/4.5 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using BF Spiromax were 640 μg and 18 μg, respectively. Participants who had currently received 1600 to 2000 μg beclomethasone-equivalent ICS per day received budesonide/formoterol twice daily using the BF Spiromax 320/9 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using BF Spiromax were 1280 μg and 36 μg, respectively. | | OG001 | Stage 2: Symbicort Turbohaler | Participants who had currently received 800 to 1000 μg beclomethasone-equivalent ICS per day received budesonide/formoterol twice daily using the Symbicort Turbohaler 200/6 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using Symbicort Turbohaler were 800 μg and 24 μg respectively. Participants who had currently received 1600 to 2000 μg beclomethasone-equivalent ICS per day received budesonide/formoterol twice daily using the Symbicort Turbohaler 400/12 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using Symbicort Turbohaler were 1600 μg and 48 μg respectively. |
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| Secondary | Stage 2: Number of Technology-Observed Errors (Vitalograph Pneumotrac Spirometer) | | FAS for Stage 2 included all randomized participants who returned for assessment of maintenance of inhaler technique at Week 12, and who had at least 10 weeks (inclusive) of device use of the inhaler (treatment) to which they were randomly assigned. | Posted | | Mean | Standard Deviation | Errors | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: BF Spiromax | Participants who had currently received 800 to 1000 μg beclomethasone-equivalent ICS per day received budesonide/formoterol twice daily using the BF Spiromax 160/4.5 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using BF Spiromax were 640 μg and 18 μg, respectively. Participants who had currently received 1600 to 2000 μg beclomethasone-equivalent ICS per day received budesonide/formoterol twice daily using the BF Spiromax 320/9 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using BF Spiromax were 1280 μg and 36 μg, respectively. | | OG001 | Stage 1: Symbicort Turbohaler | Participants who had currently received 800 to 1000 μg beclomethasone-equivalent ICS per day received budesonide/formoterol twice daily using the Symbicort Turbohaler 200/6 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using Symbicort Turbohaler were 800 μg and 24 μg respectively. Participants who had currently received 1600 to 2000 μg beclomethasone-equivalent ICS per day received budesonide/formoterol twice daily using the Symbicort Turbohaler 400/12 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using Symbicort Turbohaler were 1600 μg and 48 μg respectively. |
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| Secondary | Stage 2: Total Number of Handling Errors | Total number of device handling errors included HCP observed errors and technology observed errors. | FAS for Stage 2 included all randomized participants who returned for assessment of maintenance of inhaler technique at Week 12, and who had at least 10 weeks (inclusive) of device use of the inhaler (treatment) to which they were randomly assigned. | Posted | | Mean | Standard Deviation | errors | | Baseline up to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: BF Spiromax | Participants who had currently received 800 to 1000 μg beclomethasone-equivalent ICS per day received budesonide/formoterol twice daily using the BF Spiromax 160/4.5 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using BF Spiromax were 640 μg and 18 μg, respectively. Participants who had currently received 1600 to 2000 μg beclomethasone-equivalent ICS per day received budesonide/formoterol twice daily using the BF Spiromax 320/9 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using BF Spiromax were 1280 μg and 36 μg, respectively. | | OG001 | Stage 2: Symbicort Turbohaler | Participants who had currently received 800 to 1000 μg beclomethasone-equivalent ICS per day received budesonide/formoterol twice daily using the Symbicort Turbohaler 200/6 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using Symbicort Turbohaler were 800 μg and 24 μg respectively. Participants who had currently received 1600 to 2000 μg beclomethasone-equivalent ICS per day received budesonide/formoterol twice daily using the Symbicort Turbohaler 400/12 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using Symbicort Turbohaler were 1600 μg and 48 μg respectively. |
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| Secondary | Stage 2: Change in Handling Errors From Stage 1 to Stage 2 | The difference in the number of handling errors identified after participant training using the patient device information leaflet at stage 1 and after 12 weeks of treatment (end of stage 2). | FAS for Stage 2 included all randomized participants who returned for assessment of maintenance of inhaler technique at Week 12, and who had at least 10 weeks (inclusive) of device use of the inhaler (treatment) to which they were randomly assigned. | Posted | | Mean | Standard Deviation | Errors | | Baseline (Day 1), Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: BF Spiromax | Participants who had currently received 800 to 1000 μg beclomethasone-equivalent ICS per day received budesonide/formoterol twice daily using the BF Spiromax 160/4.5 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using BF Spiromax were 640 μg and 18 μg, respectively. Participants who had currently received 1600 to 2000 μg beclomethasone-equivalent ICS per day received budesonide/formoterol twice daily using the BF Spiromax 320/9 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using BF Spiromax were 1280 μg and 36 μg, respectively. | | OG001 | Stage 2: Symbicort Turbohaler | Participants who had currently received 800 to 1000 μg beclomethasone-equivalent ICS per day received budesonide/formoterol twice daily using the Symbicort Turbohaler 200/6 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using Symbicort Turbohaler were 800 μg and 24 μg respectively. Participants who had currently received 1600 to 2000 μg beclomethasone-equivalent ICS per day received budesonide/formoterol twice daily using the Symbicort Turbohaler 400/12 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using Symbicort Turbohaler were 1600 μg and 48 μg respectively. |
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| Secondary | Stage 2: Number of Participants In Pre-specified Treatment Adherence Categories (Assessed by Device Dose Counters) | Treatment adherence was categorized (as less than or equal to 50%, 51%-70%, 71%-99%, and 100%) and compared across treatment groups using a chi-square test. | FAS for Stage 2 included all randomized participants who returned for assessment of maintenance of inhaler technique at Week 12, and who had at least 10 weeks (inclusive) of device use of the inhaler (treatment) to which they were randomly assigned. | Posted | | Count of Participants | | Participants | | Baseline up to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: BF Spiromax | Participants who had currently received 800 to 1000 μg beclomethasone-equivalent ICS per day received budesonide/formoterol twice daily using the BF Spiromax 160/4.5 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using BF Spiromax were 640 μg and 18 μg, respectively. Participants who had currently received 1600 to 2000 μg beclomethasone-equivalent ICS per day received budesonide/formoterol twice daily using the BF Spiromax 320/9 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using BF Spiromax were 1280 μg and 36 μg, respectively. | | OG001 | Stage 2: Symbicort Turbohaler | Participants who had currently received 800 to 1000 μg beclomethasone-equivalent ICS per day received budesonide/formoterol twice daily using the Symbicort Turbohaler 200/6 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using Symbicort Turbohaler were 800 μg and 24 μg respectively. Participants who had currently received 1600 to 2000 μg beclomethasone-equivalent ICS per day received budesonide/formoterol twice daily using the Symbicort Turbohaler 400/12 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using Symbicort Turbohaler were 1600 μg and 48 μg respectively. |
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| Secondary | Stage 2: Change From Baseline in 6-Item Asthma Control Questionnaire (ACQ) (Excluding Forced Expiratory Volume in 1 Second [FEV1] Question) Score at Weeks 4, 8, and 12 | The ACQ is a 7-item, validated tool for assessing asthma control (Juniper et al 1999). Thinking about their asthma for the last 7 days, participants were asked to evaluate their asthma against 5 symptom items and a rescue bronchodilator use question using a 7-point scale (0=no impairment and 6=maximum impairment). Spirometry data were used to grade the percent predicted forced expiratory volume in 1 second (FEV1) on a 7-point scale (0 to 6). The score is the mean of the first 6 questions (excluding the FEV1 question), generating a value from 0 (totally controlled) to 6 (severely uncontrolled). A negative change from Baseline indicates improvement. | FAS for Stage 2 included all randomized participants who returned for assessment of maintenance of inhaler technique at Week 12, and who had at least 10 weeks (inclusive) of device use of the inhaler (treatment) to which they were randomly assigned. Here 'overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Weeks 4, 8, and 12 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: BF Spiromax | Participants who had currently received 800 to 1000 μg beclomethasone-equivalent ICS per day received budesonide/formoterol twice daily using the BF Spiromax 160/4.5 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using BF Spiromax were 640 μg and 18 μg, respectively. Participants who had currently received 1600 to 2000 μg beclomethasone-equivalent ICS per day received budesonide/formoterol twice daily using the BF Spiromax 320/9 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using BF Spiromax were 1280 μg and 36 μg, respectively. |
|
| Secondary | Stage 2: Change From Baseline in 7-Item ACQ | The ACQ is a 7-item, validated tool for assessing asthma control (Juniper et al 1999). Thinking about their asthma for the last 7 days, participants were asked to evaluate their asthma against 5 symptom items and a rescue bronchodilator use question using a 7-point scale (0=no impairment and 6=maximum impairment). Spirometry data were used to grade the percent predicted FEV1 on a 7-point scale (0 to 6). The ACQ score is the mean of the 7 questions, generating a value from 0 (totally controlled) to 6 (severely uncontrolled). A negative change from Baseline indicates improvement. | FAS for Stage 2 included all randomized participants who returned for assessment of maintenance of inhaler technique at Week 12, and who had at least 10 weeks (inclusive) of device use of the inhaler (treatment) to which they were randomly assigned. Here 'overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: BF Spiromax | Participants who had currently received 800 to 1000 μg beclomethasone-equivalent ICS per day received budesonide/formoterol twice daily using the BF Spiromax 160/4.5 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using BF Spiromax were 640 μg and 18 μg, respectively. Participants who had currently received 1600 to 2000 μg beclomethasone-equivalent ICS per day received budesonide/formoterol twice daily using the BF Spiromax 320/9 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using BF Spiromax were 1280 μg and 36 μg, respectively. |
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| Secondary | Stage 2: Time to First Treatment Failure | Time to treatment failure was defined as change of asthma treatment or treatment for an asthma exacerbation or lower respiratory tract infection. | FAS for Stage 2 included all randomized participants who returned for assessment of maintenance of inhaler technique at Week 12, and who had at least 10 weeks (inclusive) of device use of the inhaler (treatment) to which they were randomly assigned. | Posted | | Mean | Standard Deviation | days | | Baseline up to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: BF Spiromax | Participants who had currently received 800 to 1000 μg beclomethasone-equivalent ICS per day received budesonide/formoterol twice daily using the BF Spiromax 160/4.5 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using BF Spiromax were 640 μg and 18 μg, respectively. Participants who had currently received 1600 to 2000 μg beclomethasone-equivalent ICS per day received budesonide/formoterol twice daily using the BF Spiromax 320/9 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using BF Spiromax were 1280 μg and 36 μg, respectively. | | OG001 | Stage 2: Symbicort Turbohaler | Participants who had currently received 800 to 1000 μg beclomethasone-equivalent ICS per day received budesonide/formoterol twice daily using the Symbicort Turbohaler 200/6 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using Symbicort Turbohaler were 800 μg and 24 μg respectively. Participants who had currently received 1600 to 2000 μg beclomethasone-equivalent ICS per day received budesonide/formoterol twice daily using the Symbicort Turbohaler 400/12 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using Symbicort Turbohaler were 1600 μg and 48 μg respectively. |
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| Secondary | Stage 2: Number of Participants With Severe Asthma Exacerbations | Severe asthma exacerbation was defined as a hospitalization or emergency room attendance for asthma, or an acute course of oral corticosteroids (OCS). | FAS for Stage 2 included all randomized participants who returned for assessment of maintenance of inhaler technique at Week 12, and who had at least 10 weeks (inclusive) of device use of the inhaler (treatment) to which they were randomly assigned. | Posted | | Count of Participants | | Participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: BF Spiromax | Participants who had currently received 800 to 1000 μg beclomethasone-equivalent ICS per day received budesonide/formoterol twice daily using the BF Spiromax 160/4.5 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using BF Spiromax were 640 μg and 18 μg, respectively. Participants who had currently received 1600 to 2000 μg beclomethasone-equivalent ICS per day received budesonide/formoterol twice daily using the BF Spiromax 320/9 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using BF Spiromax were 1280 μg and 36 μg, respectively. | | OG001 | Stage 2: Symbicort Turbohaler | Participants who had currently received 800 to 1000 μg beclomethasone-equivalent ICS per day received budesonide/formoterol twice daily using the Symbicort Turbohaler 200/6 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using Symbicort Turbohaler were 800 μg and 24 μg respectively. Participants who had currently received 1600 to 2000 μg beclomethasone-equivalent ICS per day received budesonide/formoterol twice daily using the Symbicort Turbohaler 400/12 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using Symbicort Turbohaler were 1600 μg and 48 μg respectively. |
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| Secondary | Stage 2: Impact of Maintaining Device Mastery on Time to Treatment Failure | The impact of maintaining device mastery on time to treatment failure (defined as change of asthma treatment or treatment for an asthma exacerbation or lower respiratory tract infection) was assessed by comparing the time to treatment failure for participants with and without device mastery. Device mastery was defined as the absence of nurse-observed errors by the end of Step 3 of a 6-step standardized device training protocol for each device. | FAS for Stage 2 included all randomized participants who returned for assessment of maintenance of inhaler technique at Week 12, and who had at least 10 weeks (inclusive) of device use of the inhaler (treatment) to which they were randomly assigned. Here 'overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Days | | Baseline Up to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: BF Spiromax | Participants who had currently received 800 to 1000 μg beclomethasone-equivalent ICS per day received budesonide/formoterol twice daily using the BF Spiromax 160/4.5 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using BF Spiromax were 640 μg and 18 μg, respectively. Participants who had currently received 1600 to 2000 μg beclomethasone-equivalent ICS per day received budesonide/formoterol twice daily using the BF Spiromax 320/9 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using BF Spiromax were 1280 μg and 36 μg, respectively. | | OG001 |
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| Secondary | Stage 2: Impact of Maintaining Device Mastery on Asthma Control Questionnaire Score | The impact of maintaining device mastery on asthma control was assessed by comparing the 7-item ACQ scores for participants with and without device mastery. The ACQ is a 7-item, validated tool for assessing asthma control (Juniper et al 1999). Thinking about their asthma for the last 7 days, participants were asked to evaluate their asthma against 5 symptom items and a rescue bronchodilator use question using a 7-point scale (0=no impairment and 6=maximum impairment). Spirometry data were used to grade the percent predicted FEV1 on a 7-point scale (0 to 6). The ACQ score is the mean of the 7 questions, generating a value from 0 (totally controlled) to 6 (severely uncontrolled). Device mastery was defined as the absence of nurse-observed errors by the end of Step 3 of a 6-step standardized device training protocol for each device. | FAS for Stage 2 included all randomized participants who returned for assessment of maintenance of inhaler technique at Week 12, and who had at least 10 weeks (inclusive) of device use of the inhaler (treatment) to which they were randomly assigned. Here 'overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline Up to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: BF Spiromax | Participants who had currently received 800 to 1000 μg beclomethasone-equivalent ICS per day received budesonide/formoterol twice daily using the BF Spiromax 160/4.5 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using BF Spiromax were 640 μg and 18 μg, respectively. Participants who had currently received 1600 to 2000 μg beclomethasone-equivalent ICS per day received budesonide/formoterol twice daily using the BF Spiromax 320/9 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using BF Spiromax were 1280 μg and 36 μg, respectively. |
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| Secondary | Number of Participants With Adverse Events (AEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'. | The safety population for stage 2 included all participants randomly assigned to treatment who received at least 1 dose of study drug. | Posted | | Count of Participants | | Participants | | Baseline up to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: BF Spiromax | Participants who had currently received 800 to 1000 μg beclomethasone-equivalent ICS per day received budesonide/formoterol twice daily using the BF Spiromax 160/4.5 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using BF Spiromax were 640 μg and 18 μg, respectively. Participants who had currently received 1600 to 2000 μg beclomethasone-equivalent ICS per day received budesonide/formoterol twice daily using the BF Spiromax 320/9 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using BF Spiromax were 1280 μg and 36 μg, respectively. | | OG001 | Stage 2: Symbicort Turbohaler |
|