Trial Outcomes & Findings for Comparing Maintenance of Device Mastery With Turbohaler© vs. Spiromax© in Healthcare Professionals naïve to Both Devices (NCT NCT02570425)

Results Overview

Examine if recall of device mastery is superior for the SPIROMAX inhaler as compared to the TURBOHALER after training to device mastery on both devices. The proportion of subjects achieving mastery of inhaler technique between the two inhaler devices was compared using McNemar's test of equality of paired proportions with a 0.050 two- sided significance level. A Conditional Logistic Regression Model was used to quantify the difference between the two inhalers by calculating the odds ratio for achieving mastery for Spiromax® (with Turbohaler® as the reference device) along with a 95% confidence interval for quantifying the precision of the odds ratio estimate.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

516 participants

Primary outcome timeframe

4 weeks

Results posted on

2016-05-30

Participant Flow

Participants were re-randomised to either the BF Spiromax first or Symbicort Turbohaler first at each visit.

Participant milestones

Participant milestones
Measure	Placebo Comparator: Spiromax Followed by Turbohaler Training on BF Spiromax followed by SYMBICORT Turbohaler	Placebo Comparator: Turbohaler Followed by Spiromax Training on SYMBICORT Turbohaler followed by BF Spiromax
Visit 1 STARTED	274	242
Visit 1 COMPLETED	274	242
Visit 1 NOT COMPLETED	0	0
Visit 2 STARTED	251	247
Visit 2 COMPLETED	251	247
Visit 2 NOT COMPLETED	0	0
Visit 3 STARTED	229	231
Visit 3 COMPLETED	229	231
Visit 3 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparing Maintenance of Device Mastery With Turbohaler© vs. Spiromax© in Healthcare Professionals naïve to Both Devices

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SYMBICORT Turbohaler® First, Then Spiromax® n=242 Participants Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline	Budesonide/Formoterol (BF) Spiromax® First, Then Turbohaler® n=274 Participants Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device	Total n=516 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	242 Participants n=5 Participants	274 Participants n=7 Participants	516 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	22.9 years STANDARD_DEVIATION 4.5 • n=5 Participants	22.3 years STANDARD_DEVIATION 4.7 • n=7 Participants	22.6 years STANDARD_DEVIATION 4.6 • n=5 Participants
Sex: Female, Male Female	146 Participants n=5 Participants	169 Participants n=7 Participants	315 Participants n=5 Participants
Sex: Female, Male Male	96 Participants n=5 Participants	105 Participants n=7 Participants	201 Participants n=5 Participants
Region of Enrollment Australia	242 participants n=5 Participants	274 participants n=7 Participants	516 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Examine if recall of device mastery is superior for the SPIROMAX inhaler as compared to the TURBOHALER after training to device mastery on both devices. The proportion of subjects achieving mastery of inhaler technique between the two inhaler devices was compared using McNemar's test of equality of paired proportions with a 0.050 two- sided significance level. A Conditional Logistic Regression Model was used to quantify the difference between the two inhalers by calculating the odds ratio for achieving mastery for Spiromax® (with Turbohaler® as the reference device) along with a 95% confidence interval for quantifying the precision of the odds ratio estimate.

Outcome measures

Outcome measures
Measure	SYMBICORT Turbohaler® n=498 Participants Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline	Budesonide/Formoterol (BF) Spiromax® n=498 Participants Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device	No Preference HCPs indicated no preference of device during training with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device or placebo comparator: SYMBICORT® Turbohaler using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Percentage of Participants Maintaining Correct Inhaler Technique for Spiromax Compared With Turbohaler 4 Weeks After Training as Assessed by Expert Assessor	40 percent of participants	64 percent of participants	—

SECONDARY outcome

Timeframe: 0 weeks (Visit 1)

Examined for both at the end of level 1 (out of 6 level training process). This will be compared using McNemar's test of equality of paired proportions with a 0.050 two- sided significance level. A Conditional Logistic Regression Model was used to quantify the difference between the two inhalers by calculating the odds ratio for achieving mastery for Spiromax® (with Turbohaler® as the reference device) along with a 95% confidence interval for quantifying the precision of the odds ratio estimate.

Outcome measures

Outcome measures
Measure	SYMBICORT Turbohaler® n=516 Participants Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline	Budesonide/Formoterol (BF) Spiromax® n=516 Participants Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device	No Preference HCPs indicated no preference of device during training with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device or placebo comparator: SYMBICORT® Turbohaler using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Percentage of Participants Achieving Device Mastery at the End of Level 1 Out of a 6 Level Training Process as Assessed by Expert Assessor	4 percent of participants	22 percent of participants	—

SECONDARY outcome

Timeframe: 0 weeks (Visit 1)

Examined for both at the end of level 2 (out of 6 level training process). This will be compared using McNemar's test of equality of paired proportions with a 0.050 two- sided significance level. A Conditional Logistic Regression Model was used to quantify the difference between the two inhalers by calculating the odds ratio for achieving mastery for Spiromax® (with Turbohaler® as the reference device) along with a 95% confidence interval for quantifying the precision of the odds ratio estimate.

Outcome measures

Outcome measures
Measure	SYMBICORT Turbohaler® n=516 Participants Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline	Budesonide/Formoterol (BF) Spiromax® n=516 Participants Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device	No Preference HCPs indicated no preference of device during training with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device or placebo comparator: SYMBICORT® Turbohaler using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Percentage of Participants Achieving Device Mastery at the End of Level 2 Out of a 6 Level Training Process as Assessed by Expert Assessor	31 percent of participants	58 percent of participants	—

SECONDARY outcome

Timeframe: 4 weeks

Examined at the end of level 1 (out of 6 level training process). This will be compared using McNemar's test of equality of paired proportions with a 0.050 two- sided significance level. A Conditional Logistic Regression Model was used to quantify the difference between the two inhalers by calculating the odds ratio for achieving mastery for Spiromax® (with Turbohaler® as the reference device) along with a 95% confidence interval for quantifying the precision of the odds ratio estimate.

Outcome measures

Outcome measures
Measure	SYMBICORT Turbohaler® n=498 Participants Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline	Budesonide/Formoterol (BF) Spiromax® n=498 Participants Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device	No Preference HCPs indicated no preference of device during training with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device or placebo comparator: SYMBICORT® Turbohaler using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Percentage of Participants Achieving Device Mastery at the End of Level 1 Out of a 6 Level Training Process at Week 4 as Assessed by Expert Assessor	40 percent of participants	64 percent of participants	—

SECONDARY outcome

Timeframe: 4 weeks

Examined at the end of level 2 (out of 6 level training process). This will be compared using McNemar's test of equality of paired proportions with a 0.050 two- sided significance level. A Conditional Logistic Regression Model was used to quantify the difference between the two inhalers by calculating the odds ratio for achieving mastery for Spiromax® (with Turbohaler® as the reference device) along with a 95% confidence interval for quantifying the precision of the odds ratio estimate.

Outcome measures

Outcome measures
Measure	SYMBICORT Turbohaler® n=498 Participants Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline	Budesonide/Formoterol (BF) Spiromax® n=498 Participants Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device	No Preference HCPs indicated no preference of device during training with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device or placebo comparator: SYMBICORT® Turbohaler using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Percentage of Participants Achieving Device Mastery at the End of Level 2 Out of a 6 Level Training Process at Week 4 as Assessed by Expert Assessor	77 percent of participants	86 percent of participants	—

SECONDARY outcome

Timeframe: 8 weeks

Examined for both at the end of level 1 (out of 6 level training process). This will be compared using McNemar's test of equality of paired proportions with a 0.050 two- sided significance level. A Conditional Logistic Regression Model was used to quantify the difference between the two inhalers by calculating the odds ratio for achieving mastery for Spiromax® (with Turbohaler® as the reference device) along with a 95% confidence interval for quantifying the precision of the odds ratio estimate.

Outcome measures

Outcome measures
Measure	SYMBICORT Turbohaler® n=460 Participants Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline	Budesonide/Formoterol (BF) Spiromax® n=460 Participants Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device	No Preference HCPs indicated no preference of device during training with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device or placebo comparator: SYMBICORT® Turbohaler using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Percentage of Participants Achieving Device Mastery at the End of Level 1 Out of a 6 Level Training Process at Week 8 as Assessed by Expert Assessor	65 percent of participants	79 percent of participants	—

SECONDARY outcome

Timeframe: 8 weeks

Examined for both at the end of level 2 (out of 6 level training process). This will be compared using McNemar's test of equality of paired proportions with a 0.050 two- sided significance level. A Conditional Logistic Regression Model was used to quantify the difference between the two inhalers by calculating the odds ratio for achieving mastery for Spiromax® (with Turbohaler® as the reference device) along with a 95% confidence interval for quantifying the precision of the odds ratio estimate.

Outcome measures

Outcome measures
Measure	SYMBICORT Turbohaler® n=460 Participants Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline	Budesonide/Formoterol (BF) Spiromax® n=460 Participants Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device	No Preference HCPs indicated no preference of device during training with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device or placebo comparator: SYMBICORT® Turbohaler using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Percentage of Participants Achieving Device Mastery at the End of Level 2 Out of a 6 Level Training Process at Week 8 as Assessed by Expert Assessor	93 percent of participants	92 percent of participants	—

SECONDARY outcome

Timeframe: 0 weeks (Visit 1)

Number of participants achieving mastery at each level in the 6 level training process at baseline visit as assessed by expert assessor

Outcome measures

Outcome measures
Measure	SYMBICORT Turbohaler® n=516 Participants Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline	Budesonide/Formoterol (BF) Spiromax® n=516 Participants Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device	No Preference HCPs indicated no preference of device during training with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device or placebo comparator: SYMBICORT® Turbohaler using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Number of Participants Achieving Device Mastery at Levels 1-6 as Assessed by Expert Assessor Level 1: Intuitive Use	20 participants	113 participants	—
Number of Participants Achieving Device Mastery at Levels 1-6 as Assessed by Expert Assessor Level 2: Patient Information Leaflet	142 participants	186 participants	—
Number of Participants Achieving Device Mastery at Levels 1-6 as Assessed by Expert Assessor Level 3: Instructional Video	176 participants	87 participants	—
Number of Participants Achieving Device Mastery at Levels 1-6 as Assessed by Expert Assessor Level 4: Expert Tuition	158 participants	116 participants	—
Number of Participants Achieving Device Mastery at Levels 1-6 as Assessed by Expert Assessor Level 5: Repeat of Expert Tuition	19 participants	13 participants	—
Number of Participants Achieving Device Mastery at Levels 1-6 as Assessed by Expert Assessor Level 6: Second Repeat of Expert Tuition	1 participants	1 participants	—

SECONDARY outcome

Timeframe: 0 weeks (Visit 1)

Number of participants achieving mastery at each level in the 6 level training process after 4 weeks from baseline visit as assessed by expert assessor

Outcome measures

Outcome measures
Measure	SYMBICORT Turbohaler® n=498 Participants Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline	Budesonide/Formoterol (BF) Spiromax® n=498 Participants Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device	No Preference HCPs indicated no preference of device during training with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device or placebo comparator: SYMBICORT® Turbohaler using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Number of Participants Achieving Device Masteryin Levels 1-6 After 4 Weeks From Baseline Visit as Assessed by Expert Assessor Level 1: Intuitive Use	202 participants	317 participants	—
Number of Participants Achieving Device Masteryin Levels 1-6 After 4 Weeks From Baseline Visit as Assessed by Expert Assessor Level 2: Patient Information Leaflet	182 participants	113 participants	—
Number of Participants Achieving Device Masteryin Levels 1-6 After 4 Weeks From Baseline Visit as Assessed by Expert Assessor Level 3: Instructional Video	60 participants	34 participants	—
Number of Participants Achieving Device Masteryin Levels 1-6 After 4 Weeks From Baseline Visit as Assessed by Expert Assessor Level 4: Expert Tuition	47 participants	31 participants	—
Number of Participants Achieving Device Masteryin Levels 1-6 After 4 Weeks From Baseline Visit as Assessed by Expert Assessor Level 5: Repeat of Expert Tuition	7 participants	3 participants	—
Number of Participants Achieving Device Masteryin Levels 1-6 After 4 Weeks From Baseline Visit as Assessed by Expert Assessor Level 6: Second Repeat of Expert Tuition	0 participants	0 participants	—

SECONDARY outcome

Timeframe: 8 weeks

Number of participants achieving mastery at each level in the 6 level training process after 8 weeks from baseline visit as assessed by expert assessor

Outcome measures

Outcome measures
Measure	SYMBICORT Turbohaler® n=460 Participants Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline	Budesonide/Formoterol (BF) Spiromax® n=460 Participants Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device	No Preference HCPs indicated no preference of device during training with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device or placebo comparator: SYMBICORT® Turbohaler using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Number of Participants Achieving Device Mastery in Levels 1-6 After 8 Weeks From Baseline Visit as Assessed by Expert Assessor Level 1: Intuitive Use	299 participants	362 participants	—
Number of Participants Achieving Device Mastery in Levels 1-6 After 8 Weeks From Baseline Visit as Assessed by Expert Assessor Level 2: Patient Information Leaflet	127 participants	63 participants	—
Number of Participants Achieving Device Mastery in Levels 1-6 After 8 Weeks From Baseline Visit as Assessed by Expert Assessor Level 3: Instructional Video	16 participants	20 participants	—
Number of Participants Achieving Device Mastery in Levels 1-6 After 8 Weeks From Baseline Visit as Assessed by Expert Assessor Level 4: Expert Tuition	14 participants	19 participants	—
Number of Participants Achieving Device Mastery in Levels 1-6 After 8 Weeks From Baseline Visit as Assessed by Expert Assessor Level 5: Repeat of Expert Tuition	0 participants	0 participants	—
Number of Participants Achieving Device Mastery in Levels 1-6 After 8 Weeks From Baseline Visit as Assessed by Expert Assessor Level 6: Second Repeat of Expert Tuition	0 participants	0 participants	—

SECONDARY outcome

Timeframe: 4 weeks

Number of levels required to achieve device mastery out of a 6 level training processrequired by each patient at each visit as assessed by expert assessor

Outcome measures

Outcome measures
Measure	SYMBICORT Turbohaler® n=516 Participants Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline	Budesonide/Formoterol (BF) Spiromax® n=516 Participants Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device	No Preference HCPs indicated no preference of device during training with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device or placebo comparator: SYMBICORT® Turbohaler using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
The Number of Levels Out of a 6 Level Training Process Required by Each Patient on Achieving Device Mastery as Assessed by Expert Assessor Visit 1	2.48 levels Standard Deviation 1.15	3.03 levels Standard Deviation 3.0	—
The Number of Levels Out of a 6 Level Training Process Required by Each Patient on Achieving Device Mastery as Assessed by Expert Assessor Visit 2	1.57 levels Standard Deviation 0.91	1.94 levels Standard Deviation 1.01	—
The Number of Levels Out of a 6 Level Training Process Required by Each Patient on Achieving Device Mastery as Assessed by Expert Assessor Visit 3	1.33 levels Standard Deviation 0.73	1.45 levels Standard Deviation 0.72	—

SECONDARY outcome

Timeframe: 0 weeks (Visit 1)

Quantity of errors made at each level recalled during baseline visit by all participants using an expert assessor

Outcome measures

Outcome measures
Measure	SYMBICORT Turbohaler® n=516 Participants Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline	Budesonide/Formoterol (BF) Spiromax® n=516 Participants Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device	No Preference HCPs indicated no preference of device during training with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device or placebo comparator: SYMBICORT® Turbohaler using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Number of Assessor-observed Errors Recalled During Baseline Visit by All Participants	2540 errors	1447 errors	—

SECONDARY outcome

Timeframe: 4 weeks

Quantity of errors made at each level recalled by expert assessors at 4 weeks after baseline visit by all participants

Outcome measures

Outcome measures
Measure	SYMBICORT Turbohaler® n=498 Participants Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline	Budesonide/Formoterol (BF) Spiromax® n=498 Participants Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device	No Preference HCPs indicated no preference of device during training with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device or placebo comparator: SYMBICORT® Turbohaler using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Number of Assessor-observed Errors Recalled at 4 Weeks After Baseline Visit by All Participants	780 errors	367 errors	—

SECONDARY outcome

Timeframe: 8 weeks

Quantity of errors made at each level recalled by expert assessors at 8 weeks after baseline visit by all participants

Outcome measures

Outcome measures
Measure	SYMBICORT Turbohaler® n=460 Participants Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline	Budesonide/Formoterol (BF) Spiromax® n=460 Participants Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device	No Preference HCPs indicated no preference of device during training with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device or placebo comparator: SYMBICORT® Turbohaler using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Number of Assessor-observed Errors Recalled 8 Weeks After Baseline Visit by All Participants	296 errors	175 errors	—

SECONDARY outcome

Timeframe: 0 weeks (Visit 1)

Outcome measures

Outcome measures
Measure	SYMBICORT Turbohaler® n=516 Participants Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline	Budesonide/Formoterol (BF) Spiromax® n=516 Participants Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device	No Preference HCPs indicated no preference of device during training with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device or placebo comparator: SYMBICORT® Turbohaler using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Type of Participant Handling Errors Recalled by Expert Assessors at Baseline Visit by All Participants Exhales into the device before taking a dose	61 errors	101 errors	—
Type of Participant Handling Errors Recalled by Expert Assessors at Baseline Visit by All Participants Does not remove cap	0 errors	6 errors	—
Type of Participant Handling Errors Recalled by Expert Assessors at Baseline Visit by All Participants Not holding device with mouthpiece cover at bottom	62 errors	0 errors	—
Type of Participant Handling Errors Recalled by Expert Assessors at Baseline Visit by All Participants Device is not held upright (±90°) during dose prep	318 errors	0 errors	—
Type of Participant Handling Errors Recalled by Expert Assessors at Baseline Visit by All Participants Device is not held upright (±45°) during dose prep	0 errors	614 errors	—
Type of Participant Handling Errors Recalled by Expert Assessors at Baseline Visit by All Participants Not twisting the base until it clicks	0 errors	557 errors	—
Type of Participant Handling Errors Recalled by Expert Assessors at Baseline Visit by All Participants Vigorous shaking before or after dose preparation	78 errors	29 errors	—
Type of Participant Handling Errors Recalled by Expert Assessors at Baseline Visit by All Participants Inhalation is not as fast as possible from start	613 errors	581 errors	—
Type of Participant Handling Errors Recalled by Expert Assessors at Baseline Visit by All Participants Inhaler not held upright (± 45°) until inhalation	0 errors	402 errors	—
Type of Participant Handling Errors Recalled by Expert Assessors at Baseline Visit by All Participants Fails to seal lips around mouthpi	131 errors	157 errors	—
Type of Participant Handling Errors Recalled by Expert Assessors at Baseline Visit by All Participants Puts fingers or mouth/face around air inlets	105 errors	93 errors	—
Type of Participant Handling Errors Recalled by Expert Assessors at Baseline Visit by All Participants Does not open cap	28 errors	0 errors	—
Type of Participant Handling Errors Recalled by Expert Assessors at Baseline Visit by All Participants A click is not heard when the cap is opened	51 errors	0 errors	—

SECONDARY outcome

Timeframe: 4 weeks

Outcome measures

Outcome measures
Measure	SYMBICORT Turbohaler® n=498 Participants Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline	Budesonide/Formoterol (BF) Spiromax® n=498 Participants Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device	No Preference HCPs indicated no preference of device during training with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device or placebo comparator: SYMBICORT® Turbohaler using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Type of Participant Handling Errors by Expert Assessors 4 Weeks After Baseline Visit by All Participants Fails to seal lips around mouthpi	15 errors	20 errors	—
Type of Participant Handling Errors by Expert Assessors 4 Weeks After Baseline Visit by All Participants Not holding device with mouthpiece cover at bottom	6 errors	0 errors	—
Type of Participant Handling Errors by Expert Assessors 4 Weeks After Baseline Visit by All Participants Device is not held upright (±90°) during dose prep	106 errors	0 errors	—
Type of Participant Handling Errors by Expert Assessors 4 Weeks After Baseline Visit by All Participants Device is not held upright (±45°) during dose prep	0 errors	184 errors	—
Type of Participant Handling Errors by Expert Assessors 4 Weeks After Baseline Visit by All Participants Not twisting the base until it clicks	0 errors	204 errors	—
Type of Participant Handling Errors by Expert Assessors 4 Weeks After Baseline Visit by All Participants Vigorous shaking before or after dose preparation	19 errors	8 errors	—
Type of Participant Handling Errors by Expert Assessors 4 Weeks After Baseline Visit by All Participants Exhales into the device before taking a dose	23 errors	36 errors	—
Type of Participant Handling Errors by Expert Assessors 4 Weeks After Baseline Visit by All Participants Inhalation is not as fast as possible from start	148 errors	166 errors	—
Type of Participant Handling Errors by Expert Assessors 4 Weeks After Baseline Visit by All Participants Does not remove cap	0 errors	0 errors	—
Type of Participant Handling Errors by Expert Assessors 4 Weeks After Baseline Visit by All Participants Inhaler not held upright (± 45°) until inhalation	0 errors	119 errors	—
Type of Participant Handling Errors by Expert Assessors 4 Weeks After Baseline Visit by All Participants Puts fingers or mouth/face around air inlets	0 errors	43 errors	—
Type of Participant Handling Errors by Expert Assessors 4 Weeks After Baseline Visit by All Participants Does not open cap	0 errors	0 errors	—
Type of Participant Handling Errors by Expert Assessors 4 Weeks After Baseline Visit by All Participants A click is not heard when the cap is opened	2 errors	0 errors	—

SECONDARY outcome

Timeframe: 8 weeks

Outcome measures

Outcome measures
Measure	SYMBICORT Turbohaler® n=460 Participants Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline	Budesonide/Formoterol (BF) Spiromax® n=460 Participants Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device	No Preference HCPs indicated no preference of device during training with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device or placebo comparator: SYMBICORT® Turbohaler using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Type of Participant Handling Errors Recalled by Expert Assessors 8 Weeks After Baseline Visit by All Participants Not holding device with mouthpiece cover at bottom	3 errors	0 errors	—
Type of Participant Handling Errors Recalled by Expert Assessors 8 Weeks After Baseline Visit by All Participants Device is not held upright (±90°) during dose prep	34 errors	0 errors	—
Type of Participant Handling Errors Recalled by Expert Assessors 8 Weeks After Baseline Visit by All Participants Device is not held upright (±45°) during dose prep	0 errors	70 errors	—
Type of Participant Handling Errors Recalled by Expert Assessors 8 Weeks After Baseline Visit by All Participants Not twisting the base until it clicks	0 errors	49 errors	—
Type of Participant Handling Errors Recalled by Expert Assessors 8 Weeks After Baseline Visit by All Participants Vigorous shaking before or after dose preparation	6 errors	2 errors	—
Type of Participant Handling Errors Recalled by Expert Assessors 8 Weeks After Baseline Visit by All Participants Exhales into the device before taking a dose	12 errors	19 errors	—
Type of Participant Handling Errors Recalled by Expert Assessors 8 Weeks After Baseline Visit by All Participants Inhalation is not as fast as possible from start	71 errors	82 errors	—
Type of Participant Handling Errors Recalled by Expert Assessors 8 Weeks After Baseline Visit by All Participants Does not remove cap	0 errors	0 errors	—
Type of Participant Handling Errors Recalled by Expert Assessors 8 Weeks After Baseline Visit by All Participants Inhaler not held upright (± 45°) until inhalation	0 errors	30 errors	—
Type of Participant Handling Errors Recalled by Expert Assessors 8 Weeks After Baseline Visit by All Participants Fails to seal lips around mouthpi	5 errors	5 errors	—
Type of Participant Handling Errors Recalled by Expert Assessors 8 Weeks After Baseline Visit by All Participants Puts fingers or mouth/face around air inlets	41 errors	39 errors	—
Type of Participant Handling Errors Recalled by Expert Assessors 8 Weeks After Baseline Visit by All Participants Does not open cap	0 errors	0 errors	—
Type of Participant Handling Errors Recalled by Expert Assessors 8 Weeks After Baseline Visit by All Participants A click is not heard when the cap is opened	0 errors	0 errors	—

SECONDARY outcome

Timeframe: 0 weeks (Visit 1)

Device preference for either Spiromax or Turbohaler device at baseline assessed by PASAPQ Part II Q15 score

Outcome measures

Outcome measures
Measure	SYMBICORT Turbohaler® n=516 Participants Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline	Budesonide/Formoterol (BF) Spiromax® n=516 Participants Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device	No Preference n=516 Participants HCPs indicated no preference of device during training with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device or placebo comparator: SYMBICORT® Turbohaler using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Preference of Participant Device Questionnaire Assessed by PASAPQ Part II Q15 Score	74 percent of participants	16 percent of participants	10 percent of participants

SECONDARY outcome

Timeframe: 4 weeks

Device preference for either Spiromax or Turbohaler device 4 weeks after baseline visit assessed by PASAPQ Part II Q15 score

Outcome measures

Outcome measures
Measure	SYMBICORT Turbohaler® n=498 Participants Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline	Budesonide/Formoterol (BF) Spiromax® n=498 Participants Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device	No Preference n=498 Participants HCPs indicated no preference of device during training with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device or placebo comparator: SYMBICORT® Turbohaler using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Preference of Device Questionnaire 4 Weeks After Baseline Visit Assessed by PASAPQ Part II Q15 Score	74.5 percent of participants	15.5 percent of participants	10 percent of participants

SECONDARY outcome

Timeframe: 8 weeks

Device preference for either Spiromax or Turbohaler device 8 weeks after baseline visit assessed by PASAPQ Part II Q15 score

Outcome measures

Outcome measures
Measure	SYMBICORT Turbohaler® n=460 Participants Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline	Budesonide/Formoterol (BF) Spiromax® n=460 Participants Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device	No Preference n=460 Participants HCPs indicated no preference of device during training with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device or placebo comparator: SYMBICORT® Turbohaler using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training. Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Preference of Device Questionnaire 8 Weeks After Baseline Visit Assessed by PASAPQ Part II Q15 Score	79 percent of participants	14 percent of participants	7 percent of participants

Adverse Events

SYMBICORT Turbohaler®

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Budesonide/Formoterol (BF) Spiromax®

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Assoc Prof Sinthia Bosnic-Anticevich

Sydney Medical School, University of Sydney & Woolcock Institute of Medical Research

Phone: +61 2 9114 0040

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place