Study to Evaluate the Mastery of Inhaler Technique for Budesonide Formoterol (BF) SPIROMAX® as Compared to SYMBICORT® TURBOHALER® as Treatment for Adult Participants With Asthma

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).

Time frame: Baseline (Day 1)

Population: 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.

Maintenance of device mastery was defined as absence of HCP-observed errors after 12 weeks of device use.

Time frame: Baseline up to Week 12

Population: 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.

Composite score calculated as the sum of nurse observed errors and technology-observed errors.

Time frame: Baseline up to Week 12

Population: 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.

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'.

Time frame: Baseline up to Week 12

Population: The safety population for stage 2 included all participants randomly assigned to treatment who received at least 1 dose of study drug.

Time frame: Day 1

Population: 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.

Time frame: Baseline (Day 1)

Population: 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.

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.

Time frame: Baseline (Day 1)

Population: 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.

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.

Time frame: Day 1

Population: 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.

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.

Time frame: Day 1

Population: 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.

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.

Time frame: Baseline, Weeks 4, 8, and 12

Population: 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.

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.

Time frame: Baseline, Week 12

Population: 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.

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).

Time frame: Baseline (Day 1), Week 12

Population: 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.

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.

Time frame: Baseline Up to Week 12

Population: 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.

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.

Time frame: Baseline Up to Week 12

Population: 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.

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.

Time frame: Baseline up to Week 12

Population: 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.

Severe asthma exacerbation was defined as a hospitalization or emergency room attendance for asthma, or an acute course of oral corticosteroids (OCS).

Time frame: Week 12

Population: 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.

Time frame: Week 12

Population: 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.

Time to treatment failure was defined as change of asthma treatment or treatment for an asthma exacerbation or lower respiratory tract infection.

Time frame: Baseline up to Week 12

Population: 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.

Total number of device handling errors included HCP observed errors and technology observed errors.

Time frame: Baseline up to Week 12

Population: 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.