Trial Outcomes & Findings for Comparative Study of Error Rates Between ELLIPTA® Dry Powder Inhaler (DPI) and Other DPIs (NCT NCT03114969)

Results Overview

Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by the health care practitioner (HCP) in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in patient instruction leaflets (PILs) for the respective DPI. The errors made during demonstration by participants were defined as "critical", when the participant received a lesser/no dose. The percentage of participants making at least one critical error in the primary DPI is presented. The analysis was performed on the Intent to Treat (ITT) Population which comprised of all enrolled participants who demonstrated use of their primary DPI.

Recruitment status

COMPLETED

Target enrollment

450 participants

Primary outcome timeframe

Day 1

Results posted on

2020-10-28

Participant Flow

This was an open-label study investigating error rates for ELLIPTA dry powder inhaler (DPI), alone or in combination when compared to other DPIs (DISKUS, Turbuhaler, HandiHaler and Breezhaler) and combinations of these, as prescribed to chronic obstructive pulmonary disease (COPD) participants, prior to any retraining in correct use.

A total of 461 participants were screened of which 11 failed screening and 450 participants were enrolled. The study was conducted in two countries-Netherlands and the United Kingdom.

Participant milestones

Participant milestones
Measure	Relvar Ellipta Participants prescribed a fixed dose combination of inhaled corticosteroid/long-acting beta agonist (ICS/LABA) via Relvar Ellipta for treatment of COPD were included. Participants were assessed for errors while using Relvar Ellipta prior to retraining on the correct use of Ellipta DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Relvar Ellipta within 6 weeks at Visit 2.	Symbicort Turbuhaler Participants prescribed a fixed dose combination of ICS/LABA via Symbicort Turbuhaler for treatment of COPD were included. Participants were assessed for errors while using Symbicort Turbuhaler prior to retraining on the correct use of Turbuhaler at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Symbicort Turbuhaler within 6 weeks at Visit 2.	Seretide Diskus Participants prescribed a fixed dose combination of ICS/LABA via Seretide Diskus for treatment of COPD were included. Participants were assessed for errors while using Seretide Diskus prior to retraining on the correct use of Diskus at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Seretide Diskus within 6 weeks at Visit 2.	Spiriva Handihaler Participants prescribed a fixed dose of long-acting muscarinic antagonist (LAMA) via Spiriva Handihaler for treatment of COPD were included. Participants were assessed for errors while using Spiriva Handihaler prior to retraining on the correct use of Handihaler at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Spiriva Handihaler within 6 weeks at Visit 2.	Incruse/Anoro Ellipta Participants prescribed a fixed dose of LAMA via Incruse Ellipta or participants taking a fixed dose combination of LAMA/LABA via Anoro Ellipta for treatment of COPD were included. Participants were assessed for errors while using Incruse/Anoro Ellipta prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Incruse/Anoro Ellipta within 6 weeks at Visit 2.	Ultibro/Seebri Breezhaler Participants prescribed a fixed dose of LAMA via Seebri Breezehaler or participants taking a fixed dose combination of LAMA/LABA via a single DPI of Ultibro Breezehaler for treatment of COPD were included. Participants were assessed for errors while using Ultibro/Seebri Breezehaler prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Ultibro/Seebri Breezehaler within 6 weeks at Visit 2.	Relvar Ellipta+LAMA Participants prescribed a fixed dose combination of ICS/LABA via Relvar Ellipta along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.	Symbicort Turbuhaler+LAMA Participants prescribed a fixed dose combination of ICS/LABA via Symbicort Turbuhaler along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.	Seretide Diskus+LAMA Participants prescribed a fixed dose combination of ICS/LABA via Seretide Diskus along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.
Overall Study STARTED	50	50	50	50	51	49	50	50	50
Overall Study COMPLETED	50	50	46	48	51	48	49	50	48
Overall Study NOT COMPLETED	0	0	4	2	0	1	1	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Relvar Ellipta Participants prescribed a fixed dose combination of inhaled corticosteroid/long-acting beta agonist (ICS/LABA) via Relvar Ellipta for treatment of COPD were included. Participants were assessed for errors while using Relvar Ellipta prior to retraining on the correct use of Ellipta DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Relvar Ellipta within 6 weeks at Visit 2.	Symbicort Turbuhaler Participants prescribed a fixed dose combination of ICS/LABA via Symbicort Turbuhaler for treatment of COPD were included. Participants were assessed for errors while using Symbicort Turbuhaler prior to retraining on the correct use of Turbuhaler at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Symbicort Turbuhaler within 6 weeks at Visit 2.	Seretide Diskus Participants prescribed a fixed dose combination of ICS/LABA via Seretide Diskus for treatment of COPD were included. Participants were assessed for errors while using Seretide Diskus prior to retraining on the correct use of Diskus at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Seretide Diskus within 6 weeks at Visit 2.	Spiriva Handihaler Participants prescribed a fixed dose of long-acting muscarinic antagonist (LAMA) via Spiriva Handihaler for treatment of COPD were included. Participants were assessed for errors while using Spiriva Handihaler prior to retraining on the correct use of Handihaler at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Spiriva Handihaler within 6 weeks at Visit 2.	Incruse/Anoro Ellipta Participants prescribed a fixed dose of LAMA via Incruse Ellipta or participants taking a fixed dose combination of LAMA/LABA via Anoro Ellipta for treatment of COPD were included. Participants were assessed for errors while using Incruse/Anoro Ellipta prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Incruse/Anoro Ellipta within 6 weeks at Visit 2.	Ultibro/Seebri Breezhaler Participants prescribed a fixed dose of LAMA via Seebri Breezehaler or participants taking a fixed dose combination of LAMA/LABA via a single DPI of Ultibro Breezehaler for treatment of COPD were included. Participants were assessed for errors while using Ultibro/Seebri Breezehaler prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Ultibro/Seebri Breezehaler within 6 weeks at Visit 2.	Relvar Ellipta+LAMA Participants prescribed a fixed dose combination of ICS/LABA via Relvar Ellipta along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.	Symbicort Turbuhaler+LAMA Participants prescribed a fixed dose combination of ICS/LABA via Symbicort Turbuhaler along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.	Seretide Diskus+LAMA Participants prescribed a fixed dose combination of ICS/LABA via Seretide Diskus along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.
Overall Study Lost to Follow-up	0	0	3	2	0	0	0	0	0
Overall Study Adverse Event	0	0	1	0	0	1	1	0	2

Baseline Characteristics

Comparative Study of Error Rates Between ELLIPTA® Dry Powder Inhaler (DPI) and Other DPIs

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Relvar Ellipta n=50 Participants Participants prescribed a fixed dose combination of inhaled corticosteroid/long-acting beta agonist (ICS/LABA) via Relvar Ellipta for treatment of COPD were included. Participants were assessed for errors while using Relvar Ellipta prior to retraining on the correct use of Ellipta DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Relvar Ellipta within 6 weeks at Visit 2.	Symbicort Turbuhaler n=50 Participants Participants prescribed a fixed dose combination of ICS/LABA via Symbicort Turbuhaler for treatment of COPD were included. Participants were assessed for errors while using Symbicort Turbuhaler prior to retraining on the correct use of Turbuhaler at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Symbicort Turbuhaler within 6 weeks at Visit 2.	Seretide Diskus n=50 Participants Participants prescribed a fixed dose combination of ICS/LABA via Seretide Diskus for treatment of COPD were included. Participants were assessed for errors while using Seretide Diskus prior to retraining on the correct use of Diskus at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Seretide Diskus within 6 weeks at Visit 2.	Spiriva Handihaler n=50 Participants Participants prescribed a fixed dose of long-acting muscarinic antagonist (LAMA) via Spiriva Handihaler for treatment of COPD were included. Participants were assessed for errors while using Spiriva Handihaler prior to retraining on the correct use of Handihaler at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Spiriva Handihaler within 6 weeks at Visit 2.	Incruse/Anoro Ellipta n=51 Participants Participants prescribed a fixed dose of LAMA via Incruse Ellipta or participants taking a fixed dose combination of LAMA/LABA via Anoro Ellipta for treatment of COPD were included. Participants were assessed for errors while using Incruse/Anoro Ellipta prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Incruse/Anoro Ellipta within 6 weeks at Visit 2.	Ultibro/Seebri Breezhaler n=49 Participants Participants prescribed a fixed dose of LAMA via Seebri Breezehaler or participants taking a fixed dose combination of LAMA/LABA via a single DPI of Ultibro Breezehaler for treatment of COPD were included. Participants were assessed for errors while using Ultibro/Seebri Breezehaler prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Ultibro/Seebri Breezehaler within 6 weeks at Visit 2.	Relvar Ellipta+LAMA n=50 Participants Participants prescribed a fixed dose combination of ICS/LABA via Relvar Ellipta along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.	Symbicort Turbuhaler+LAMA n=50 Participants Participants prescribed a fixed dose combination of ICS/LABA via Symbicort Turbuhaler along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.	Seretide Diskus+LAMA n=50 Participants Participants prescribed a fixed dose combination of ICS/LABA via Seretide Diskus along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.	Total n=450 Participants Total of all reporting groups
Age, Continuous	64.6 Years STANDARD_DEVIATION 10.24 • n=93 Participants	65.2 Years STANDARD_DEVIATION 11.43 • n=4 Participants	68.7 Years STANDARD_DEVIATION 10.67 • n=27 Participants	69.5 Years STANDARD_DEVIATION 9.95 • n=483 Participants	66.8 Years STANDARD_DEVIATION 8.93 • n=36 Participants	67.7 Years STANDARD_DEVIATION 10.01 • n=10 Participants	66.6 Years STANDARD_DEVIATION 8.44 • n=115 Participants	67.5 Years STANDARD_DEVIATION 8.21 • n=40 Participants	68.1 Years STANDARD_DEVIATION 9.16 • n=8 Participants	67.2 Years STANDARD_DEVIATION 9.75 • n=62 Participants
Sex: Female, Male Female	29 Participants n=93 Participants	26 Participants n=4 Participants	29 Participants n=27 Participants	21 Participants n=483 Participants	24 Participants n=36 Participants	19 Participants n=10 Participants	28 Participants n=115 Participants	18 Participants n=40 Participants	14 Participants n=8 Participants	208 Participants n=62 Participants
Sex: Female, Male Male	21 Participants n=93 Participants	24 Participants n=4 Participants	21 Participants n=27 Participants	29 Participants n=483 Participants	27 Participants n=36 Participants	30 Participants n=10 Participants	22 Participants n=115 Participants	32 Participants n=40 Participants	36 Participants n=8 Participants	242 Participants n=62 Participants
Race/Ethnicity, Customized African American/African Heritage	0 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	1 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=40 Participants	0 Participants n=8 Participants	3 Participants n=62 Participants
Race/Ethnicity, Customized Asian-Central/South Asian Heritage	0 Participants n=93 Participants	0 Participants n=4 Participants	4 Participants n=27 Participants	0 Participants n=483 Participants	3 Participants n=36 Participants	1 Participants n=10 Participants	2 Participants n=115 Participants	2 Participants n=40 Participants	3 Participants n=8 Participants	15 Participants n=62 Participants
Race/Ethnicity, Customized Asian-East Asian Heritage	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=40 Participants	0 Participants n=8 Participants	1 Participants n=62 Participants
Race/Ethnicity, Customized Asian-Japanese Heritage	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=40 Participants	0 Participants n=8 Participants	1 Participants n=62 Participants
Race/Ethnicity, Customized Asian-South East Asian Heritage	0 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=40 Participants	1 Participants n=8 Participants	2 Participants n=62 Participants
Race/Ethnicity, Customized White-Arabic/North African Heritage	0 Participants n=93 Participants	1 Participants n=4 Participants	4 Participants n=27 Participants	1 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	0 Participants n=40 Participants	0 Participants n=8 Participants	7 Participants n=62 Participants
Race/Ethnicity, Customized White-White/Caucasian/European Heritage	49 Participants n=93 Participants	48 Participants n=4 Participants	41 Participants n=27 Participants	49 Participants n=483 Participants	47 Participants n=36 Participants	47 Participants n=10 Participants	47 Participants n=115 Participants	47 Participants n=40 Participants	46 Participants n=8 Participants	421 Participants n=62 Participants

PRIMARY outcome

Timeframe: Day 1

Population: ITT Population

Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by the health care practitioner (HCP) in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in patient instruction leaflets (PILs) for the respective DPI. The errors made during demonstration by participants were defined as "critical", when the participant received a lesser/no dose. The percentage of participants making at least one critical error in the primary DPI is presented. The analysis was performed on the Intent to Treat (ITT) Population which comprised of all enrolled participants who demonstrated use of their primary DPI.

Outcome measures

Outcome measures
Measure	Relvar Ellipta n=50 Participants Participants prescribed a fixed dose combination of inhaled corticosteroid/long-acting beta agonist (ICS/LABA) via Relvar Ellipta for treatment of COPD were included. Participants were assessed for errors while using Relvar Ellipta prior to retraining on the correct use of Ellipta DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Relvar Ellipta within 6 weeks at Visit 2.	Symbicort Turbuhaler n=50 Participants Participants prescribed a fixed dose combination of ICS/LABA via Symbicort Turbuhaler for treatment of COPD were included. Participants were assessed for errors while using Symbicort Turbuhaler prior to retraining on the correct use of Turbuhaler at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Symbicort Turbuhaler within 6 weeks at Visit 2.	Seretide Diskus n=50 Participants Participants prescribed a fixed dose combination of ICS/LABA via Seretide Diskus for treatment of COPD were included. Participants were assessed for errors while using Seretide Diskus prior to retraining on the correct use of Diskus at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Seretide Diskus within 6 weeks at Visit 2.	Spiriva Handihaler n=50 Participants Participants prescribed a fixed dose of long-acting muscarinic antagonist (LAMA) via Spiriva Handihaler for treatment of COPD were included. Participants were assessed for errors while using Spiriva Handihaler prior to retraining on the correct use of Handihaler at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Spiriva Handihaler within 6 weeks at Visit 2.	Incruse/Anoro Ellipta n=51 Participants Participants prescribed a fixed dose of LAMA via Incruse Ellipta or participants taking a fixed dose combination of LAMA/LABA via Anoro Ellipta for treatment of COPD were included. Participants were assessed for errors while using Incruse/Anoro Ellipta prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Incruse/Anoro Ellipta within 6 weeks at Visit 2.	Ultibro/Seebri Breezhaler n=49 Participants Participants prescribed a fixed dose of LAMA via Seebri Breezehaler or participants taking a fixed dose combination of LAMA/LABA via a single DPI of Ultibro Breezehaler for treatment of COPD were included. Participants were assessed for errors while using Ultibro/Seebri Breezehaler prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Ultibro/Seebri Breezehaler within 6 weeks at Visit 2.	Relvar Ellipta+LAMA n=50 Participants Participants prescribed a fixed dose combination of ICS/LABA via Relvar Ellipta along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.	Symbicort Turbuhaler+LAMA n=50 Participants Participants prescribed a fixed dose combination of ICS/LABA via Symbicort Turbuhaler along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.	Seretide Diskus+LAMA n=50 Participants Participants prescribed a fixed dose combination of ICS/LABA via Seretide Diskus along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.
Percentage of Participants Making at Least One Critical Error at Visit 1-Primary Device Comparisons	10 Percentage of participants	40 Percentage of participants	26 Percentage of participants	34 Percentage of participants	10 Percentage of participants	33 Percentage of participants	12 Percentage of participants	38 Percentage of participants	26 Percentage of participants

PRIMARY outcome

Timeframe: Day 1

Population: ITT Population

Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as "critical", when the participant received a lesser/no dose. The percentage of participants making at least one critical error in the primary DPI is presented. The aim of the analysis was to compare percentage of participants making at least one critical error with Ellipta versus all ICS/LABA+LAMA DPIs; hence, the arms were combined as pre-specified in the protocol and reporting and analysis plan (RAP).

Outcome measures

Outcome measures
Measure	Relvar Ellipta n=150 Participants Participants prescribed a fixed dose combination of inhaled corticosteroid/long-acting beta agonist (ICS/LABA) via Relvar Ellipta for treatment of COPD were included. Participants were assessed for errors while using Relvar Ellipta prior to retraining on the correct use of Ellipta DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Relvar Ellipta within 6 weeks at Visit 2.	Symbicort Turbuhaler n=50 Participants Participants prescribed a fixed dose combination of ICS/LABA via Symbicort Turbuhaler for treatment of COPD were included. Participants were assessed for errors while using Symbicort Turbuhaler prior to retraining on the correct use of Turbuhaler at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Symbicort Turbuhaler within 6 weeks at Visit 2.	Seretide Diskus Participants prescribed a fixed dose combination of ICS/LABA via Seretide Diskus for treatment of COPD were included. Participants were assessed for errors while using Seretide Diskus prior to retraining on the correct use of Diskus at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Seretide Diskus within 6 weeks at Visit 2.	Spiriva Handihaler Participants prescribed a fixed dose of long-acting muscarinic antagonist (LAMA) via Spiriva Handihaler for treatment of COPD were included. Participants were assessed for errors while using Spiriva Handihaler prior to retraining on the correct use of Handihaler at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Spiriva Handihaler within 6 weeks at Visit 2.	Incruse/Anoro Ellipta Participants prescribed a fixed dose of LAMA via Incruse Ellipta or participants taking a fixed dose combination of LAMA/LABA via Anoro Ellipta for treatment of COPD were included. Participants were assessed for errors while using Incruse/Anoro Ellipta prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Incruse/Anoro Ellipta within 6 weeks at Visit 2.	Ultibro/Seebri Breezhaler Participants prescribed a fixed dose of LAMA via Seebri Breezehaler or participants taking a fixed dose combination of LAMA/LABA via a single DPI of Ultibro Breezehaler for treatment of COPD were included. Participants were assessed for errors while using Ultibro/Seebri Breezehaler prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Ultibro/Seebri Breezehaler within 6 weeks at Visit 2.	Relvar Ellipta+LAMA Participants prescribed a fixed dose combination of ICS/LABA via Relvar Ellipta along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.	Symbicort Turbuhaler+LAMA Participants prescribed a fixed dose combination of ICS/LABA via Symbicort Turbuhaler along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.	Seretide Diskus+LAMA Participants prescribed a fixed dose combination of ICS/LABA via Seretide Diskus along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.
Percentage of Participants Making at Least One Critical Error at Visit 1 in Primary DPI (Relvar Ellipta DPI Versus All ICS/LABA DPIs With a LAMA Second DPI)	25 Percentage of participants	10 Percentage of participants	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 1

Population: ITT Population

Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as "critical", when the participant received a lesser/no dose. The percentage of participants making at least one critical error in the primary DPI is presented. The aim of the analysis was to compare percentage of participants making at least one critical error with Ellipta and Ellipta+LAMA versus Turbuhaler and Turbuhaler+LAMA and Diskus and Diskus+LAMA; hence, the arms were combined as pre-specified in the protocol and RAP.

Outcome measures

Outcome measures
Measure	Relvar Ellipta n=100 Participants Participants prescribed a fixed dose combination of inhaled corticosteroid/long-acting beta agonist (ICS/LABA) via Relvar Ellipta for treatment of COPD were included. Participants were assessed for errors while using Relvar Ellipta prior to retraining on the correct use of Ellipta DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Relvar Ellipta within 6 weeks at Visit 2.	Symbicort Turbuhaler n=100 Participants Participants prescribed a fixed dose combination of ICS/LABA via Symbicort Turbuhaler for treatment of COPD were included. Participants were assessed for errors while using Symbicort Turbuhaler prior to retraining on the correct use of Turbuhaler at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Symbicort Turbuhaler within 6 weeks at Visit 2.	Seretide Diskus n=100 Participants Participants prescribed a fixed dose combination of ICS/LABA via Seretide Diskus for treatment of COPD were included. Participants were assessed for errors while using Seretide Diskus prior to retraining on the correct use of Diskus at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Seretide Diskus within 6 weeks at Visit 2.	Spiriva Handihaler Participants prescribed a fixed dose of long-acting muscarinic antagonist (LAMA) via Spiriva Handihaler for treatment of COPD were included. Participants were assessed for errors while using Spiriva Handihaler prior to retraining on the correct use of Handihaler at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Spiriva Handihaler within 6 weeks at Visit 2.	Incruse/Anoro Ellipta Participants prescribed a fixed dose of LAMA via Incruse Ellipta or participants taking a fixed dose combination of LAMA/LABA via Anoro Ellipta for treatment of COPD were included. Participants were assessed for errors while using Incruse/Anoro Ellipta prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Incruse/Anoro Ellipta within 6 weeks at Visit 2.	Ultibro/Seebri Breezhaler Participants prescribed a fixed dose of LAMA via Seebri Breezehaler or participants taking a fixed dose combination of LAMA/LABA via a single DPI of Ultibro Breezehaler for treatment of COPD were included. Participants were assessed for errors while using Ultibro/Seebri Breezehaler prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Ultibro/Seebri Breezehaler within 6 weeks at Visit 2.	Relvar Ellipta+LAMA Participants prescribed a fixed dose combination of ICS/LABA via Relvar Ellipta along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.	Symbicort Turbuhaler+LAMA Participants prescribed a fixed dose combination of ICS/LABA via Symbicort Turbuhaler along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.	Seretide Diskus+LAMA Participants prescribed a fixed dose combination of ICS/LABA via Seretide Diskus along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.
Percentage of Participants Making at Least One Critical Error at Visit 1 in Primary DPI (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI	11 Percentage of participants	39 Percentage of participants	26 Percentage of participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 1

Population: ITT Population

Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as "critical", when the participant received a lesser/no dose. The percentage of participants making at least one critical error in either one or both devices (where applicable) is presented.

Outcome measures

Outcome measures
Measure	Relvar Ellipta n=50 Participants Participants prescribed a fixed dose combination of inhaled corticosteroid/long-acting beta agonist (ICS/LABA) via Relvar Ellipta for treatment of COPD were included. Participants were assessed for errors while using Relvar Ellipta prior to retraining on the correct use of Ellipta DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Relvar Ellipta within 6 weeks at Visit 2.	Symbicort Turbuhaler n=50 Participants Participants prescribed a fixed dose combination of ICS/LABA via Symbicort Turbuhaler for treatment of COPD were included. Participants were assessed for errors while using Symbicort Turbuhaler prior to retraining on the correct use of Turbuhaler at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Symbicort Turbuhaler within 6 weeks at Visit 2.	Seretide Diskus Participants prescribed a fixed dose combination of ICS/LABA via Seretide Diskus for treatment of COPD were included. Participants were assessed for errors while using Seretide Diskus prior to retraining on the correct use of Diskus at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Seretide Diskus within 6 weeks at Visit 2.	Spiriva Handihaler Participants prescribed a fixed dose of long-acting muscarinic antagonist (LAMA) via Spiriva Handihaler for treatment of COPD were included. Participants were assessed for errors while using Spiriva Handihaler prior to retraining on the correct use of Handihaler at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Spiriva Handihaler within 6 weeks at Visit 2.	Incruse/Anoro Ellipta Participants prescribed a fixed dose of LAMA via Incruse Ellipta or participants taking a fixed dose combination of LAMA/LABA via Anoro Ellipta for treatment of COPD were included. Participants were assessed for errors while using Incruse/Anoro Ellipta prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Incruse/Anoro Ellipta within 6 weeks at Visit 2.	Ultibro/Seebri Breezhaler Participants prescribed a fixed dose of LAMA via Seebri Breezehaler or participants taking a fixed dose combination of LAMA/LABA via a single DPI of Ultibro Breezehaler for treatment of COPD were included. Participants were assessed for errors while using Ultibro/Seebri Breezehaler prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Ultibro/Seebri Breezehaler within 6 weeks at Visit 2.	Relvar Ellipta+LAMA Participants prescribed a fixed dose combination of ICS/LABA via Relvar Ellipta along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.	Symbicort Turbuhaler+LAMA Participants prescribed a fixed dose combination of ICS/LABA via Symbicort Turbuhaler along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.	Seretide Diskus+LAMA Participants prescribed a fixed dose combination of ICS/LABA via Seretide Diskus along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.
Percentage of Participants Making at Least One Critical Error at Visit 1-Dual Device Comparisons (Relvar Ellipta DPI Versus Relvar Ellipta With Any Other LAMA)	10 Percentage of participants	22 Percentage of participants	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 1

Population: ITT Population

Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as "critical", when the participant received a lesser/no dose. The percentage of participants making at least one critical error in either one or both devices (where applicable) is presented. The aim of the analysis was to compare percentage of participants making at least one critical error with Ellipta versus all ICS/LABA+LAMA DPIs; hence, the arms were combined as pre-specified in the protocol and RAP.

Outcome measures

Outcome measures
Measure	Relvar Ellipta n=50 Participants Participants prescribed a fixed dose combination of inhaled corticosteroid/long-acting beta agonist (ICS/LABA) via Relvar Ellipta for treatment of COPD were included. Participants were assessed for errors while using Relvar Ellipta prior to retraining on the correct use of Ellipta DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Relvar Ellipta within 6 weeks at Visit 2.	Symbicort Turbuhaler n=150 Participants Participants prescribed a fixed dose combination of ICS/LABA via Symbicort Turbuhaler for treatment of COPD were included. Participants were assessed for errors while using Symbicort Turbuhaler prior to retraining on the correct use of Turbuhaler at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Symbicort Turbuhaler within 6 weeks at Visit 2.	Seretide Diskus Participants prescribed a fixed dose combination of ICS/LABA via Seretide Diskus for treatment of COPD were included. Participants were assessed for errors while using Seretide Diskus prior to retraining on the correct use of Diskus at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Seretide Diskus within 6 weeks at Visit 2.	Spiriva Handihaler Participants prescribed a fixed dose of long-acting muscarinic antagonist (LAMA) via Spiriva Handihaler for treatment of COPD were included. Participants were assessed for errors while using Spiriva Handihaler prior to retraining on the correct use of Handihaler at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Spiriva Handihaler within 6 weeks at Visit 2.	Incruse/Anoro Ellipta Participants prescribed a fixed dose of LAMA via Incruse Ellipta or participants taking a fixed dose combination of LAMA/LABA via Anoro Ellipta for treatment of COPD were included. Participants were assessed for errors while using Incruse/Anoro Ellipta prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Incruse/Anoro Ellipta within 6 weeks at Visit 2.	Ultibro/Seebri Breezhaler Participants prescribed a fixed dose of LAMA via Seebri Breezehaler or participants taking a fixed dose combination of LAMA/LABA via a single DPI of Ultibro Breezehaler for treatment of COPD were included. Participants were assessed for errors while using Ultibro/Seebri Breezehaler prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Ultibro/Seebri Breezehaler within 6 weeks at Visit 2.	Relvar Ellipta+LAMA Participants prescribed a fixed dose combination of ICS/LABA via Relvar Ellipta along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.	Symbicort Turbuhaler+LAMA Participants prescribed a fixed dose combination of ICS/LABA via Symbicort Turbuhaler along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.	Seretide Diskus+LAMA Participants prescribed a fixed dose combination of ICS/LABA via Seretide Diskus along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.
Percentage of Participants Making at Least One Critical Error at Visit 1-Dual Device Comparisons (Relvar Ellipta DPI Versus All ICS/LABA DPIs With a LAMA Second DPI)	10 Percentage of participants	41 Percentage of participants	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 1

Population: ITT Population

Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as "critical", when the participant received a lesser/no dose. The percentage of participants making at least one critical error in either one or both devices (where applicable) is presented. The aim of the analysis was to compare percentage of participants making at least one critical error with Ellipta and Ellipta+LAMA versus Turbuhaler and Turbuhaler+LAMA and Diskus and Diskus+LAMA; hence, the arms were combined as pre-specified in the protocol and RAP.

Outcome measures

Outcome measures
Measure	Relvar Ellipta n=100 Participants Participants prescribed a fixed dose combination of inhaled corticosteroid/long-acting beta agonist (ICS/LABA) via Relvar Ellipta for treatment of COPD were included. Participants were assessed for errors while using Relvar Ellipta prior to retraining on the correct use of Ellipta DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Relvar Ellipta within 6 weeks at Visit 2.	Symbicort Turbuhaler n=100 Participants Participants prescribed a fixed dose combination of ICS/LABA via Symbicort Turbuhaler for treatment of COPD were included. Participants were assessed for errors while using Symbicort Turbuhaler prior to retraining on the correct use of Turbuhaler at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Symbicort Turbuhaler within 6 weeks at Visit 2.	Seretide Diskus n=100 Participants Participants prescribed a fixed dose combination of ICS/LABA via Seretide Diskus for treatment of COPD were included. Participants were assessed for errors while using Seretide Diskus prior to retraining on the correct use of Diskus at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Seretide Diskus within 6 weeks at Visit 2.	Spiriva Handihaler Participants prescribed a fixed dose of long-acting muscarinic antagonist (LAMA) via Spiriva Handihaler for treatment of COPD were included. Participants were assessed for errors while using Spiriva Handihaler prior to retraining on the correct use of Handihaler at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Spiriva Handihaler within 6 weeks at Visit 2.	Incruse/Anoro Ellipta Participants prescribed a fixed dose of LAMA via Incruse Ellipta or participants taking a fixed dose combination of LAMA/LABA via Anoro Ellipta for treatment of COPD were included. Participants were assessed for errors while using Incruse/Anoro Ellipta prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Incruse/Anoro Ellipta within 6 weeks at Visit 2.	Ultibro/Seebri Breezhaler Participants prescribed a fixed dose of LAMA via Seebri Breezehaler or participants taking a fixed dose combination of LAMA/LABA via a single DPI of Ultibro Breezehaler for treatment of COPD were included. Participants were assessed for errors while using Ultibro/Seebri Breezehaler prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Ultibro/Seebri Breezehaler within 6 weeks at Visit 2.	Relvar Ellipta+LAMA Participants prescribed a fixed dose combination of ICS/LABA via Relvar Ellipta along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.	Symbicort Turbuhaler+LAMA Participants prescribed a fixed dose combination of ICS/LABA via Symbicort Turbuhaler along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.	Seretide Diskus+LAMA Participants prescribed a fixed dose combination of ICS/LABA via Seretide Diskus along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.
Percentage of Participants Making at Least One Critical Error at Visit 1-Dual Device Comparisons (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI)	16 Percentage of participants	47 Percentage of participants	36 Percentage of participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1

Population: ITT Population

Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as "critical", when the participant received a lesser/no dose and non-critical when the dose may not be affected, but the participant has demonstrated improper use of their DPI, as per the PIL. Overall errors is the combination of critical and non-critical errors. The percentage of participants with at least one overall error in the primary DPI is presented.

Outcome measures

Outcome measures
Measure	Relvar Ellipta n=50 Participants Participants prescribed a fixed dose combination of inhaled corticosteroid/long-acting beta agonist (ICS/LABA) via Relvar Ellipta for treatment of COPD were included. Participants were assessed for errors while using Relvar Ellipta prior to retraining on the correct use of Ellipta DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Relvar Ellipta within 6 weeks at Visit 2.	Symbicort Turbuhaler n=50 Participants Participants prescribed a fixed dose combination of ICS/LABA via Symbicort Turbuhaler for treatment of COPD were included. Participants were assessed for errors while using Symbicort Turbuhaler prior to retraining on the correct use of Turbuhaler at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Symbicort Turbuhaler within 6 weeks at Visit 2.	Seretide Diskus n=50 Participants Participants prescribed a fixed dose combination of ICS/LABA via Seretide Diskus for treatment of COPD were included. Participants were assessed for errors while using Seretide Diskus prior to retraining on the correct use of Diskus at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Seretide Diskus within 6 weeks at Visit 2.	Spiriva Handihaler n=50 Participants Participants prescribed a fixed dose of long-acting muscarinic antagonist (LAMA) via Spiriva Handihaler for treatment of COPD were included. Participants were assessed for errors while using Spiriva Handihaler prior to retraining on the correct use of Handihaler at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Spiriva Handihaler within 6 weeks at Visit 2.	Incruse/Anoro Ellipta n=51 Participants Participants prescribed a fixed dose of LAMA via Incruse Ellipta or participants taking a fixed dose combination of LAMA/LABA via Anoro Ellipta for treatment of COPD were included. Participants were assessed for errors while using Incruse/Anoro Ellipta prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Incruse/Anoro Ellipta within 6 weeks at Visit 2.	Ultibro/Seebri Breezhaler n=49 Participants Participants prescribed a fixed dose of LAMA via Seebri Breezehaler or participants taking a fixed dose combination of LAMA/LABA via a single DPI of Ultibro Breezehaler for treatment of COPD were included. Participants were assessed for errors while using Ultibro/Seebri Breezehaler prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Ultibro/Seebri Breezehaler within 6 weeks at Visit 2.	Relvar Ellipta+LAMA n=50 Participants Participants prescribed a fixed dose combination of ICS/LABA via Relvar Ellipta along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.	Symbicort Turbuhaler+LAMA n=50 Participants Participants prescribed a fixed dose combination of ICS/LABA via Symbicort Turbuhaler along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.	Seretide Diskus+LAMA n=50 Participants Participants prescribed a fixed dose combination of ICS/LABA via Seretide Diskus along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.
Percentage of Participants Making at Least One Overall Error at Visit 1-Primary Device Comparisons	34 Percentage of participants	64 Percentage of participants	60 Percentage of participants	74 Percentage of participants	37 Percentage of participants	55 Percentage of participants	34 Percentage of participants	70 Percentage of participants	66 Percentage of participants

SECONDARY outcome

Timeframe: Day 1

Population: ITT Population

Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as "critical", when the participant received a lesser/no dose and non-critical when the dose may not be affected, but the participant has demonstrated improper use of their DPI, as per the PIL. Overall errors is the combination of critical and non-critical errors. The percentage of participants with at least one overall error in primary DPI is presented. The aim of the analysis was to compare percentage of participants making at least one overall error with Ellipta versus all ICS/LABA+LAMA DPIs; hence, the arms were combined as pre-specified in the protocol and RAP.

Outcome measures

Outcome measures
Measure	Relvar Ellipta n=150 Participants Participants prescribed a fixed dose combination of inhaled corticosteroid/long-acting beta agonist (ICS/LABA) via Relvar Ellipta for treatment of COPD were included. Participants were assessed for errors while using Relvar Ellipta prior to retraining on the correct use of Ellipta DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Relvar Ellipta within 6 weeks at Visit 2.	Symbicort Turbuhaler n=50 Participants Participants prescribed a fixed dose combination of ICS/LABA via Symbicort Turbuhaler for treatment of COPD were included. Participants were assessed for errors while using Symbicort Turbuhaler prior to retraining on the correct use of Turbuhaler at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Symbicort Turbuhaler within 6 weeks at Visit 2.	Seretide Diskus Participants prescribed a fixed dose combination of ICS/LABA via Seretide Diskus for treatment of COPD were included. Participants were assessed for errors while using Seretide Diskus prior to retraining on the correct use of Diskus at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Seretide Diskus within 6 weeks at Visit 2.	Spiriva Handihaler Participants prescribed a fixed dose of long-acting muscarinic antagonist (LAMA) via Spiriva Handihaler for treatment of COPD were included. Participants were assessed for errors while using Spiriva Handihaler prior to retraining on the correct use of Handihaler at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Spiriva Handihaler within 6 weeks at Visit 2.	Incruse/Anoro Ellipta Participants prescribed a fixed dose of LAMA via Incruse Ellipta or participants taking a fixed dose combination of LAMA/LABA via Anoro Ellipta for treatment of COPD were included. Participants were assessed for errors while using Incruse/Anoro Ellipta prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Incruse/Anoro Ellipta within 6 weeks at Visit 2.	Ultibro/Seebri Breezhaler Participants prescribed a fixed dose of LAMA via Seebri Breezehaler or participants taking a fixed dose combination of LAMA/LABA via a single DPI of Ultibro Breezehaler for treatment of COPD were included. Participants were assessed for errors while using Ultibro/Seebri Breezehaler prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Ultibro/Seebri Breezehaler within 6 weeks at Visit 2.	Relvar Ellipta+LAMA Participants prescribed a fixed dose combination of ICS/LABA via Relvar Ellipta along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.	Symbicort Turbuhaler+LAMA Participants prescribed a fixed dose combination of ICS/LABA via Symbicort Turbuhaler along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.	Seretide Diskus+LAMA Participants prescribed a fixed dose combination of ICS/LABA via Seretide Diskus along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.
Percentage of Participants Making at Least One Overall Error at Visit 1 in Primary DPI (Relvar Ellipta DPI Versus All ICS/LABA DPIs With a LAMA Second DPI)	57 Percentage of participants	34 Percentage of participants	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1

Population: ITT Population

Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as "critical", when the participant received a lesser/no dose and non-critical when the dose may not be affected, but the participant has demonstrated improper use of their DPI, as per the PIL. Overall errors is the combination of critical and non-critical errors. The percentage of participants with at least one overall error in primary DPI is presented. The aim of the analysis was to compare percentage of participants making at least one overall error with Ellipta and Ellipta+LAMA versus Turbuhaler and Turbuhaler+LAMA and Diskus and Diskus+LAMA; hence, the arms were combined as pre-specified in the protocol and RAP.

Outcome measures

Outcome measures
Measure	Relvar Ellipta n=100 Participants Participants prescribed a fixed dose combination of inhaled corticosteroid/long-acting beta agonist (ICS/LABA) via Relvar Ellipta for treatment of COPD were included. Participants were assessed for errors while using Relvar Ellipta prior to retraining on the correct use of Ellipta DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Relvar Ellipta within 6 weeks at Visit 2.	Symbicort Turbuhaler n=100 Participants Participants prescribed a fixed dose combination of ICS/LABA via Symbicort Turbuhaler for treatment of COPD were included. Participants were assessed for errors while using Symbicort Turbuhaler prior to retraining on the correct use of Turbuhaler at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Symbicort Turbuhaler within 6 weeks at Visit 2.	Seretide Diskus n=100 Participants Participants prescribed a fixed dose combination of ICS/LABA via Seretide Diskus for treatment of COPD were included. Participants were assessed for errors while using Seretide Diskus prior to retraining on the correct use of Diskus at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Seretide Diskus within 6 weeks at Visit 2.	Spiriva Handihaler Participants prescribed a fixed dose of long-acting muscarinic antagonist (LAMA) via Spiriva Handihaler for treatment of COPD were included. Participants were assessed for errors while using Spiriva Handihaler prior to retraining on the correct use of Handihaler at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Spiriva Handihaler within 6 weeks at Visit 2.	Incruse/Anoro Ellipta Participants prescribed a fixed dose of LAMA via Incruse Ellipta or participants taking a fixed dose combination of LAMA/LABA via Anoro Ellipta for treatment of COPD were included. Participants were assessed for errors while using Incruse/Anoro Ellipta prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Incruse/Anoro Ellipta within 6 weeks at Visit 2.	Ultibro/Seebri Breezhaler Participants prescribed a fixed dose of LAMA via Seebri Breezehaler or participants taking a fixed dose combination of LAMA/LABA via a single DPI of Ultibro Breezehaler for treatment of COPD were included. Participants were assessed for errors while using Ultibro/Seebri Breezehaler prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Ultibro/Seebri Breezehaler within 6 weeks at Visit 2.	Relvar Ellipta+LAMA Participants prescribed a fixed dose combination of ICS/LABA via Relvar Ellipta along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.	Symbicort Turbuhaler+LAMA Participants prescribed a fixed dose combination of ICS/LABA via Symbicort Turbuhaler along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.	Seretide Diskus+LAMA Participants prescribed a fixed dose combination of ICS/LABA via Seretide Diskus along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.
Percentage of Participants Making at Least One Overall Error at Visit 1 in Primary DPI (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI	34 Percentage of participants	67 Percentage of participants	63 Percentage of participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1

Population: ITT Population

Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as "critical", when the participant received a lesser/no dose and non-critical when the dose may not be affected, but the participant has demonstrated improper use of their DPI, as per the PIL. Overall errors is the combination of critical and non-critical errors. The percentage of participants making at least one overall error in either one or both devices (where applicable) is presented.

Outcome measures

Outcome measures
Measure	Relvar Ellipta n=50 Participants Participants prescribed a fixed dose combination of inhaled corticosteroid/long-acting beta agonist (ICS/LABA) via Relvar Ellipta for treatment of COPD were included. Participants were assessed for errors while using Relvar Ellipta prior to retraining on the correct use of Ellipta DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Relvar Ellipta within 6 weeks at Visit 2.	Symbicort Turbuhaler n=50 Participants Participants prescribed a fixed dose combination of ICS/LABA via Symbicort Turbuhaler for treatment of COPD were included. Participants were assessed for errors while using Symbicort Turbuhaler prior to retraining on the correct use of Turbuhaler at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Symbicort Turbuhaler within 6 weeks at Visit 2.	Seretide Diskus Participants prescribed a fixed dose combination of ICS/LABA via Seretide Diskus for treatment of COPD were included. Participants were assessed for errors while using Seretide Diskus prior to retraining on the correct use of Diskus at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Seretide Diskus within 6 weeks at Visit 2.	Spiriva Handihaler Participants prescribed a fixed dose of long-acting muscarinic antagonist (LAMA) via Spiriva Handihaler for treatment of COPD were included. Participants were assessed for errors while using Spiriva Handihaler prior to retraining on the correct use of Handihaler at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Spiriva Handihaler within 6 weeks at Visit 2.	Incruse/Anoro Ellipta Participants prescribed a fixed dose of LAMA via Incruse Ellipta or participants taking a fixed dose combination of LAMA/LABA via Anoro Ellipta for treatment of COPD were included. Participants were assessed for errors while using Incruse/Anoro Ellipta prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Incruse/Anoro Ellipta within 6 weeks at Visit 2.	Ultibro/Seebri Breezhaler Participants prescribed a fixed dose of LAMA via Seebri Breezehaler or participants taking a fixed dose combination of LAMA/LABA via a single DPI of Ultibro Breezehaler for treatment of COPD were included. Participants were assessed for errors while using Ultibro/Seebri Breezehaler prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Ultibro/Seebri Breezehaler within 6 weeks at Visit 2.	Relvar Ellipta+LAMA Participants prescribed a fixed dose combination of ICS/LABA via Relvar Ellipta along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.	Symbicort Turbuhaler+LAMA Participants prescribed a fixed dose combination of ICS/LABA via Symbicort Turbuhaler along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.	Seretide Diskus+LAMA Participants prescribed a fixed dose combination of ICS/LABA via Seretide Diskus along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.
Percentage of Participants Making at Least One Overall Error at Visit 1-Dual Device Comparisons (Relvar Ellipta DPI Versus Relvar Ellipta With Any Other LAMA)	34 Percentage of participants	46 Percentage of participants	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1

Population: ITT Population

Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. Errors made during demonstration by participants were defined as "critical", when the participant received a lesser/no dose and non-critical when the dose may not be affected, but the participant has demonstrated improper use of their DPI, as per the PIL. Overall errors is the combination of critical and non-critical errors. Percentage of participants making at least one overall error in either one or both devices (where applicable) is presented. The aim of the analysis was to compare percentage of participants making at least one overall error with Ellipta versus all ICS/LABA+LAMA DPIs; hence, the arms were combined as pre-specified in the protocol and RAP.

Outcome measures

Outcome measures
Measure	Relvar Ellipta n=50 Participants Participants prescribed a fixed dose combination of inhaled corticosteroid/long-acting beta agonist (ICS/LABA) via Relvar Ellipta for treatment of COPD were included. Participants were assessed for errors while using Relvar Ellipta prior to retraining on the correct use of Ellipta DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Relvar Ellipta within 6 weeks at Visit 2.	Symbicort Turbuhaler n=150 Participants Participants prescribed a fixed dose combination of ICS/LABA via Symbicort Turbuhaler for treatment of COPD were included. Participants were assessed for errors while using Symbicort Turbuhaler prior to retraining on the correct use of Turbuhaler at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Symbicort Turbuhaler within 6 weeks at Visit 2.	Seretide Diskus Participants prescribed a fixed dose combination of ICS/LABA via Seretide Diskus for treatment of COPD were included. Participants were assessed for errors while using Seretide Diskus prior to retraining on the correct use of Diskus at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Seretide Diskus within 6 weeks at Visit 2.	Spiriva Handihaler Participants prescribed a fixed dose of long-acting muscarinic antagonist (LAMA) via Spiriva Handihaler for treatment of COPD were included. Participants were assessed for errors while using Spiriva Handihaler prior to retraining on the correct use of Handihaler at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Spiriva Handihaler within 6 weeks at Visit 2.	Incruse/Anoro Ellipta Participants prescribed a fixed dose of LAMA via Incruse Ellipta or participants taking a fixed dose combination of LAMA/LABA via Anoro Ellipta for treatment of COPD were included. Participants were assessed for errors while using Incruse/Anoro Ellipta prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Incruse/Anoro Ellipta within 6 weeks at Visit 2.	Ultibro/Seebri Breezhaler Participants prescribed a fixed dose of LAMA via Seebri Breezehaler or participants taking a fixed dose combination of LAMA/LABA via a single DPI of Ultibro Breezehaler for treatment of COPD were included. Participants were assessed for errors while using Ultibro/Seebri Breezehaler prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Ultibro/Seebri Breezehaler within 6 weeks at Visit 2.	Relvar Ellipta+LAMA Participants prescribed a fixed dose combination of ICS/LABA via Relvar Ellipta along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.	Symbicort Turbuhaler+LAMA Participants prescribed a fixed dose combination of ICS/LABA via Symbicort Turbuhaler along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.	Seretide Diskus+LAMA Participants prescribed a fixed dose combination of ICS/LABA via Seretide Diskus along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.
Percentage of Participants Making at Least One Overall Error at Visit 1-Dual Device Comparisons (Relvar Ellipta DPI Versus All ICS/LABA DPIs With a LAMA Second DPI)	34 Percentage of participants	71 Percentage of participants	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1

Population: ITT Population

Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. Errors made during demonstration by participants were defined as "critical", when the participant received a lesser/no dose and non-critical when the dose may not be affected, but the participant has demonstrated improper use of their DPI, as per the PIL. Overall errors is the combination of critical and non-critical errors. Percentage of participants making at least one overall error in either one or both devices (where applicable) is presented.The aim of the analysis was to compare percentage of participants making at least one overall error with Ellipta and Ellipta+LAMA versus Turbuhaler and Turbuhaler+LAMA and Diskus and Diskus+LAMA; hence, the arms were combined as pre-specified in the protocol and RAP.