Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
Overall error, Error rate, Critical error, COPD, ELLIPTA, Dry powder inhaler
Brief summary
For effective drug delivery using inhalation route, it is important to use the inhalers correctly. This open-label study will evaluate the error rates during the use of ELLIPTA DPI, alone or in combination, in comparison with other DPIs. The study aims to provide clinical evidence in subjects with COPD that the reduced number of steps required to use the ELLIPTA DPI could result in fewer errors made by subjects, and therefore a more consistent treatment. Approximately 450 subjects prescribed with either of RELVAR® ELLIPTA, ANORO® ELLIPTA, INCRUSE® ELLIPTA, SYMBICORT® TURBUHALER®, SERETIDE® DISKUS®, SPIRIVA® HANDIHALER®, ULTIBRO® BREEZHALER® or SEEBRI® BREEZHALER will be included in the study and will have 2 clinical visits. At Visit 1, subjects will take their maintenance DPIs and the critical and overall errors made by subjects will be assessed. After the assessment, subjects will be instructed on correct use or informed of their correct use of their DPIs. The total duration of the study is approximately 6 weeks. ELLIPTA, SERETIDE and DISKUS are registered trademarks of the GSK group of companies. SYMBICORT and TURBUHALER are registered trademarks of the AstraZeneca group of companies. SPIRIVA and HANDIHALER are registered trademarks of Boehringer Ingelheim Pharmaceuticals. ULTIBRO, BREEZHALER and SEEBRI are registered trademarks of the Novartis group of companies.
Interventions
DEVICERelvar ELLIPTA
ELLIPTA inhaler containing Relvar will be used by subjects as their maintenance treatment to control COPD.
DEVICESymbicort TURBUHALER
TURBUHALER inhaler containing Symbicort will be used by subjects as their maintenance treatment to control COPD.
DEVICESeretide DISKUS
DISKUS inhaler containing Seretide will be used by subjects as their maintenance treatment to control COPD.
DEVICESpiriva HANDIHALER
HANDIHALER inhaler containing Spiriva will be used by subjects as their maintenance treatment to control COPD.
DEVICEBREEZHALER
BREEZHALER inhaler containing either Seebri or Ultibro will be used by subjects as their maintenance treatment to control COPD.
DEVICEIncruse ELLIPTA
ELLIPTA inhaler containing Incruse will be used by subjects as their maintenance treatment to control COPD.
DEVICEAnoro ELLIPTA
ELLIPTA inhaler containing Anoro will be used by subjects as their maintenance treatment to control COPD.
Sponsors
GlaxoSmithKline
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects with documented Physician's diagnosis of COPD, and currently receiving maintenance therapy. * Aged \>=40 years of age at inclusion. * Using one of the maintenance therapies of interest for at least 3 months prior to inclusion on the study. * Males or females. * Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the consent form and in the protocol.
Exclusion criteria
* Asthma: Subjects with a current diagnosis of asthma. Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD. * Drug/alcohol abuse: Subjects with a known or suspected alcohol or drug abuse history at screening (Visit 0) that in the opinion of the investigator could interfere with the subject's proper completion of the protocol requirement. * Investigational product: Subjects who have received an investigational drug and/or medical device within 30 days of entry into this study (Screening/Visit 1), or within five half-lives of the investigational drug, whichever is longer. * Investigational product: Subjects who have been trained during participation in any device study in the 6 months prior to entry into this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Making at Least One Critical Error at Visit 1-Primary Device Comparisons | Day 1 | 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. |
| 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) | Day 1 | 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). |
| 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 | Day 1 | 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. |
| 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) | Day 1 | 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. |
| 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) | Day 1 | 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. |
| 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) | Day 1 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Making at Least One Critical Error at Visit 2-Primary Device Comparisons | Week 6 | Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. 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. |
| Percentage of Participants Making at Least One Critical Error at Visit 2 in Primary DPI (Relvar Ellipta DPI Versus All ICS/LABA DPIs With a LAMA Second DPI) | Week 6 | Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. 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 RAP. |
| Percentage of Participants Making at Least One Critical Error at Visit 2 in Primary DPI (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI | Week 6 | Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. 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 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. |
| Percentage of Participants Making at Least One Critical Error at Visit 2-Dual Device Comparisons (Relvar Ellipta DPI Versus Relvar Ellipta With Any Other LAMA) | Week 6 | Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. 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. |
| Percentage of Participants Making at Least One Critical Error at Visit 2-Dual Device Comparisons (Relvar Ellipta DPI Versus All ICS/LABA DPIs With a LAMA Second DPI) | Week 6 | Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. 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. |
| Percentage of Participants Making at Least One Critical Error at Visit 2-Dual Device Comparisons (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI) | Week 6 | Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. 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. |
| Percentage of Participants Making at Least One Overall Error at Visit 1-Primary Device Comparisons | Day 1 | 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. |
| Percentage of Participants Making at Least One Overall Error at Visit 2 in Primary DPI (Relvar Ellipta DPI Versus All ICS/LABA DPIs With a LAMA Second DPI) | Week 6 | Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. 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 listed in PILs for the respective DPI. The errors 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 PIL. Overall errors is the combination of critical and non-critical errors. The percentage of participants making 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. |
| Percentage of Participants Making at Least One Overall Error at Visit 2 in Primary DPI (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI | Week 6 | Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. 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 listed in PILs for the respective DPI. The errors 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 PIL. Overall errors is the combination of critical and non-critical errors. The percentage of participants making 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. . |
| Percentage of Participants Making at Least One Overall Error at Visit 2-Dual Device Comparisons (Relvar Ellipta DPI Versus Relvar Ellipta With Any Other LAMA) | Week 6 | Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. 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. |
| Percentage of Participants Making at Least One Overall Error at Visit 2-Dual Device Comparisons (Relvar Ellipta DPI Versus All ICS/LABA DPIs With a LAMA Second DPI) | Week 6 | Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on correct use of inhalers. Any error made by the participant was recorded by HCP in the checklist. Checklist of instructions for correct use were based on 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 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. |
| Percentage of Participants Making at Least One Overall Error at Visit 2-Dual Device Comparisons (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI) | Week 6 | Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. 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 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. |
| Percentage of Participants Making at Least One Overall Error at Visit 2-Primary Device Comparisons | Week 6 | Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. 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 the primary DPI is presented. |
| 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) | Day 1 | 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. |
| 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 | Day 1 | 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. |
| 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) | Day 1 | 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. |
| 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) | Day 1 | 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. |
| Percentage of Participants Making at Least One Overall 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) | Day 1 | 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. |
Countries
Netherlands, United Kingdom
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 50 |
| 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. | 50 |
| 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. | 50 |
| 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. | 50 |
| 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. | 51 |
| 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. | 49 |
| 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. | 50 |
| 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. | 50 |
| 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. | 50 |
| Total | 450 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 |
|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 0 | 0 | 1 | 1 | 0 | 2 |
| Overall Study | Lost to Follow-up | 0 | 0 | 3 | 2 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Relvar Ellipta | Symbicort Turbuhaler | Seretide Diskus | Spiriva Handihaler | Incruse/Anoro Ellipta | Ultibro/Seebri Breezhaler | Relvar Ellipta+LAMA | Symbicort Turbuhaler+LAMA | Seretide Diskus+LAMA | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 64.6 Years STANDARD_DEVIATION 10.24 | 65.2 Years STANDARD_DEVIATION 11.43 | 68.7 Years STANDARD_DEVIATION 10.67 | 69.5 Years STANDARD_DEVIATION 9.95 | 66.8 Years STANDARD_DEVIATION 8.93 | 67.7 Years STANDARD_DEVIATION 10.01 | 66.6 Years STANDARD_DEVIATION 8.44 | 67.5 Years STANDARD_DEVIATION 8.21 | 68.1 Years STANDARD_DEVIATION 9.16 | 67.2 Years STANDARD_DEVIATION 9.75 |
| Race/Ethnicity, Customized African American/African Heritage | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian-Central/South Asian Heritage | 0 Participants | 0 Participants | 4 Participants | 0 Participants | 3 Participants | 1 Participants | 2 Participants | 2 Participants | 3 Participants | 15 Participants |
| Race/Ethnicity, Customized Asian-East Asian Heritage | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian-Japanese Heritage | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian-South East Asian Heritage | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized White-Arabic/North African Heritage | 0 Participants | 1 Participants | 4 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 7 Participants |
| Race/Ethnicity, Customized White-White/Caucasian/European Heritage | 49 Participants | 48 Participants | 41 Participants | 49 Participants | 47 Participants | 47 Participants | 47 Participants | 47 Participants | 46 Participants | 421 Participants |
| Sex: Female, Male Female | 29 Participants | 26 Participants | 29 Participants | 21 Participants | 24 Participants | 19 Participants | 28 Participants | 18 Participants | 14 Participants | 208 Participants |
| Sex: Female, Male Male | 21 Participants | 24 Participants | 21 Participants | 29 Participants | 27 Participants | 30 Participants | 22 Participants | 32 Participants | 36 Participants | 242 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 | 0 / 50 | 0 / 50 | 0 / 51 | 0 / 49 | 0 / 50 | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 4 / 50 | 1 / 50 | 0 / 50 | 1 / 50 | 2 / 51 | 2 / 49 | 3 / 50 | 3 / 50 | 5 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 | 0 / 50 | 0 / 50 | 1 / 51 | 1 / 49 | 0 / 50 | 1 / 50 | 0 / 50 |
Outcome results
Primary
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)
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.
Time frame: Day 1
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Relvar Ellipta | 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 |
| Symbicort Turbuhaler | 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) | 41 Percentage of participants |
p-value: 0.00195% CI: [1.851, 12.903]Regression, Logistic
p-value: <0.00195% CI: [2.106, 14.284]Regression, Logistic
Primary
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)
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.
Time frame: Day 1
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Relvar Ellipta | 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 |
| Symbicort Turbuhaler | 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) | 22 Percentage of participants |
p-value: 0.10895% CI: [0.818, 7.659]Regression, Logistic
p-value: 0.12295% CI: [0.792, 7.331]Regression, Logistic
Primary
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)
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.
Time frame: Day 1
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Relvar Ellipta | 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 |
| Symbicort Turbuhaler | 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) | 47 Percentage of participants |
| Seretide Diskus | 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) | 36 Percentage of participants |
p-value: <0.00195% CI: [1.863, 8.337]Regression, Logistic
p-value: 0.0395% CI: [1.088, 5.256]Regression, Logistic
p-value: <0.00195% CI: [2.388, 9.364]Regression, Logistic
p-value: 0.00295% CI: [1.473, 5.936]Regression, Logistic
Primary
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)
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).
Time frame: Day 1
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Relvar Ellipta | 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 |
| Symbicort Turbuhaler | 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) | 10 Percentage of participants |
p-value: 0.195% CI: [0.853, 6.163]Regression, Logistic
p-value: 0.05195% CI: [0.994, 7.022]Regression, Logistic
Primary
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
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.
Time frame: Day 1
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Relvar Ellipta | 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 |
| Symbicort Turbuhaler | 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 | 39 Percentage of participants |
| Seretide Diskus | 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 | 26 Percentage of participants |
p-value: <0.00195% CI: [1.808, 8.829]Regression, Logistic
p-value: 0.06995% CI: [0.94, 5.059]Regression, Logistic
p-value: <0.00195% CI: [2.339, 10.08]Regression, Logistic
p-value: 0.0195% CI: [1.274, 5.764]Regression, Logistic
Primary
Percentage of Participants Making at Least One Critical Error at Visit 1-Primary Device Comparisons
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.
Time frame: Day 1
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Relvar Ellipta | Percentage of Participants Making at Least One Critical Error at Visit 1-Primary Device Comparisons | 10 Percentage of participants |
| Symbicort Turbuhaler | Percentage of Participants Making at Least One Critical Error at Visit 1-Primary Device Comparisons | 40 Percentage of participants |
| Seretide Diskus | Percentage of Participants Making at Least One Critical Error at Visit 1-Primary Device Comparisons | 26 Percentage of participants |
| Spiriva Handihaler | Percentage of Participants Making at Least One Critical Error at Visit 1-Primary Device Comparisons | 34 Percentage of participants |
| Incruse/Anoro Ellipta | Percentage of Participants Making at Least One Critical Error at Visit 1-Primary Device Comparisons | 10 Percentage of participants |
| Ultibro/Seebri Breezhaler | Percentage of Participants Making at Least One Critical Error at Visit 1-Primary Device Comparisons | 33 Percentage of participants |
| Relvar Ellipta+LAMA | Percentage of Participants Making at Least One Critical Error at Visit 1-Primary Device Comparisons | 12 Percentage of participants |
| Symbicort Turbuhaler+LAMA | Percentage of Participants Making at Least One Critical Error at Visit 1-Primary Device Comparisons | 38 Percentage of participants |
| Seretide Diskus+LAMA | Percentage of Participants Making at Least One Critical Error at Visit 1-Primary Device Comparisons | 26 Percentage of participants |
p-value: 0.00595% CI: [1.584, 13.686]Regression, Logistic
p-value: 0.11495% CI: [0.805, 7.632]Regression, Logistic
p-value: 0.02695% CI: [1.16, 10.555]Regression, Logistic
p-value: 0.01295% CI: [1.348, 11.534]Regression, Logistic
p-value: 0.74695% CI: [0.361, 4.151]Regression, Logistic
p-value: 0.00195% CI: [1.932, 16.013]Regression, Logistic
p-value: 0.0595% CI: [0.999, 8.882]Regression, Logistic
p-value: 0.00695% CI: [1.521, 12.834]Regression, Logistic
p-value: 0.00995% CI: [1.425, 12.178]Regression, Logistic
p-value: 0.76195% CI: [0.357, 4.095]Regression, Logistic
Secondary
Percentage of Participants Making at Least One Critical Error at Visit 2-Dual Device Comparisons (Relvar Ellipta DPI Versus All ICS/LABA DPIs With a LAMA Second DPI)
Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. 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.
Time frame: Week 6
Population: ITT Population. Only those participants with data available at Visit 2 were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Relvar Ellipta | Percentage of Participants Making at Least One Critical Error at Visit 2-Dual Device Comparisons (Relvar Ellipta DPI Versus All ICS/LABA DPIs With a LAMA Second DPI) | 0 Percentage of participants |
| Symbicort Turbuhaler | Percentage of Participants Making at Least One Critical Error at Visit 2-Dual Device Comparisons (Relvar Ellipta DPI Versus All ICS/LABA DPIs With a LAMA Second DPI) | 13 Percentage of participants |
p-value: 0.07995% CI: [0.753, 188.208]Regression, Logistic
p-value: 0.06395% CI: [0.866, 262.042]Regression, Logistic
Secondary
Percentage of Participants Making at Least One Critical Error at Visit 2-Dual Device Comparisons (Relvar Ellipta DPI Versus Relvar Ellipta With Any Other LAMA)
Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. 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.
Time frame: Week 6
Population: ITT Population. Only those participants with data available at Visit 2 were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Relvar Ellipta | Percentage of Participants Making at Least One Critical Error at Visit 2-Dual Device Comparisons (Relvar Ellipta DPI Versus Relvar Ellipta With Any Other LAMA) | 0 Percentage of participants |
| Symbicort Turbuhaler | Percentage of Participants Making at Least One Critical Error at Visit 2-Dual Device Comparisons (Relvar Ellipta DPI Versus Relvar Ellipta With Any Other LAMA) | 8 Percentage of participants |
p-value: 0.0995% CI: [0.68, 216.818]Regression, Logistic
p-value: 0.1395% CI: [0.508, 196.435]Regression, Logistic
Secondary
Percentage of Participants Making at Least One Critical Error at Visit 2-Dual Device Comparisons (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI)
Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. 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.
Time frame: Week 6
Population: ITT Population. Only those participants with data available at Visit 2 were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Relvar Ellipta | Percentage of Participants Making at Least One Critical Error at Visit 2-Dual Device Comparisons (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI) | 4 Percentage of participants |
| Symbicort Turbuhaler | Percentage of Participants Making at Least One Critical Error at Visit 2-Dual Device Comparisons (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI) | 11 Percentage of participants |
| Seretide Diskus | Percentage of Participants Making at Least One Critical Error at Visit 2-Dual Device Comparisons (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI) | 13 Percentage of participants |
p-value: 0.23995% CI: [0.521, 13.69]Regression, Logistic
p-value: 0.295% CI: [0.567, 15.125]Regression, Logistic
p-value: 0.07895% CI: [0.848, 21.489]Regression, Logistic
p-value: 0.04695% CI: [1.031, 25.55]Regression, Logistic
Secondary
Percentage of Participants Making at Least One Critical Error at Visit 2 in Primary DPI (Relvar Ellipta DPI Versus All ICS/LABA DPIs With a LAMA Second DPI)
Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. 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 RAP.
Time frame: Week 6
Population: ITT Population. Only those participants with data available at Visit 2 were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Relvar Ellipta | Percentage of Participants Making at Least One Critical Error at Visit 2 in Primary DPI (Relvar Ellipta DPI Versus All ICS/LABA DPIs With a LAMA Second DPI) | 8 Percentage of participants |
| Symbicort Turbuhaler | Percentage of Participants Making at Least One Critical Error at Visit 2 in Primary DPI (Relvar Ellipta DPI Versus All ICS/LABA DPIs With a LAMA Second DPI) | 0 Percentage of participants |
p-value: 0.14795% CI: [0.488, 124.117]Regression, Logistic
p-value: 0.1295% CI: [0.553, 173.301]Regression, Logistic
Secondary
Percentage of Participants Making at Least One Critical Error at Visit 2 in Primary DPI (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI
Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. 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 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.
Time frame: Week 6
Population: ITT Population. Only those participants with data available at Visit 2 were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Relvar Ellipta | Percentage of Participants Making at Least One Critical Error at Visit 2 in Primary DPI (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI | 3 Percentage of participants |
| Symbicort Turbuhaler | Percentage of Participants Making at Least One Critical Error at Visit 2 in Primary DPI (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI | 7 Percentage of participants |
| Seretide Diskus | Percentage of Participants Making at Least One Critical Error at Visit 2 in Primary DPI (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI | 12 Percentage of participants |
p-value: 0.39595% CI: [0.383, 11.389]Regression, Logistic
p-value: 0.16695% CI: [0.612, 17.244]Regression, Logistic
p-value: 0.17595% CI: [0.596, 17.14]Regression, Logistic
p-value: 0.04295% CI: [1.059, 27.61]Regression, Logistic
Secondary
Percentage of Participants Making at Least One Critical Error at Visit 2-Primary Device Comparisons
Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. 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.
Time frame: Week 6
Population: ITT Population. Only those participants with data available at Visit 2 were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Relvar Ellipta | Percentage of Participants Making at Least One Critical Error at Visit 2-Primary Device Comparisons | 0 Percentage of participants |
| Symbicort Turbuhaler | Percentage of Participants Making at Least One Critical Error at Visit 2-Primary Device Comparisons | 8 Percentage of participants |
| Seretide Diskus | Percentage of Participants Making at Least One Critical Error at Visit 2-Primary Device Comparisons | 11 Percentage of participants |
| Spiriva Handihaler | Percentage of Participants Making at Least One Critical Error at Visit 2-Primary Device Comparisons | 21 Percentage of participants |
| Incruse/Anoro Ellipta | Percentage of Participants Making at Least One Critical Error at Visit 2-Primary Device Comparisons | 0 Percentage of participants |
| Ultibro/Seebri Breezhaler | Percentage of Participants Making at Least One Critical Error at Visit 2-Primary Device Comparisons | 17 Percentage of participants |
| Relvar Ellipta+LAMA | Percentage of Participants Making at Least One Critical Error at Visit 2-Primary Device Comparisons | 6 Percentage of participants |
| Symbicort Turbuhaler+LAMA | Percentage of Participants Making at Least One Critical Error at Visit 2-Primary Device Comparisons | 6 Percentage of participants |
| Seretide Diskus+LAMA | Percentage of Participants Making at Least One Critical Error at Visit 2-Primary Device Comparisons | 13 Percentage of participants |
p-value: 0.17695% CI: [0.408, 132.143]Regression, Logistic
p-value: 0.12895% CI: [0.526, 164.465]Regression, Logistic
p-value: 0.03895% CI: [1.19, 351.613]Regression, Logistic
p-value: 0.04195% CI: [1.131, 311.669]Regression, Logistic
p-value: 0.14195% CI: [0.484, 162.775]Regression, Logistic
p-value: 0.12695% CI: [0.519, 200.904]Regression, Logistic
p-value: 0.08295% CI: [0.715, 263.125]Regression, Logistic
p-value: 0.02495% CI: [1.561, 512.532]Regression, Logistic
p-value: 0.03895% CI: [1.183, 399.541]Regression, Logistic
p-value: 0.18895% CI: [0.371, 155.763]Regression, Logistic
Secondary
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)
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.
Time frame: Day 1
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Relvar Ellipta | 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 |
| Symbicort Turbuhaler | 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) | 71 Percentage of participants |
p-value: <0.00195% CI: [2.019, 8.807]Regression, Logistic
p-value: <0.00195% CI: [2.66, 11.005]Regression, Logistic
Secondary
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)
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.
Time frame: Day 1
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Relvar Ellipta | 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 |
| Symbicort Turbuhaler | 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) | 46 Percentage of participants |
p-value: 0.1295% CI: [0.842, 4.428]Regression, Logistic
p-value: 0.23295% CI: [0.73, 3.664]Regression, Logistic
Secondary
Percentage of Participants Making at Least One Overall 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)
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.
Time frame: Day 1
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Relvar Ellipta | Percentage of Participants Making at Least One Overall 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) | 40 Percentage of participants |
| Symbicort Turbuhaler | Percentage of Participants Making at Least One Overall 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) | 72 Percentage of participants |
| Seretide Diskus | Percentage of Participants Making at Least One Overall 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) | 74 Percentage of participants |
p-value: 0.00795% CI: [1.274, 4.815]Regression, Logistic
p-value: 0.00695% CI: [1.328, 5.683]Regression, Logistic
p-value: <0.00195% CI: [2.133, 7.118]Regression, Logistic
p-value: <0.00195% CI: [2.508, 9.1]Regression, Logistic
Secondary
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)
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.
Time frame: Day 1
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Relvar Ellipta | 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 |
| Symbicort Turbuhaler | 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) | 34 Percentage of participants |
p-value: 0.06795% CI: [0.955, 3.921]Regression, Logistic
p-value: 0.00795% CI: [1.283, 4.961]Regression, Logistic
Secondary
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
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.
Time frame: Day 1
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Relvar Ellipta | 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 |
| Symbicort Turbuhaler | 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 | 67 Percentage of participants |
| Seretide Diskus | 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 | 63 Percentage of participants |
p-value: 0.00895% CI: [1.252, 4.596]Regression, Logistic
p-value: 0.08295% CI: [0.926, 3.544]Regression, Logistic
p-value: <0.00195% CI: [2.135, 6.905]Regression, Logistic
p-value: <0.00195% CI: [1.81, 5.766]Regression, Logistic
Secondary
Percentage of Participants Making at Least One Overall Error at Visit 1-Primary Device Comparisons
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.
Time frame: Day 1
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Relvar Ellipta | Percentage of Participants Making at Least One Overall Error at Visit 1-Primary Device Comparisons | 34 Percentage of participants |
| Symbicort Turbuhaler | Percentage of Participants Making at Least One Overall Error at Visit 1-Primary Device Comparisons | 64 Percentage of participants |
| Seretide Diskus | Percentage of Participants Making at Least One Overall Error at Visit 1-Primary Device Comparisons | 60 Percentage of participants |
| Spiriva Handihaler | Percentage of Participants Making at Least One Overall Error at Visit 1-Primary Device Comparisons | 74 Percentage of participants |
| Incruse/Anoro Ellipta | Percentage of Participants Making at Least One Overall Error at Visit 1-Primary Device Comparisons | 37 Percentage of participants |
| Ultibro/Seebri Breezhaler | Percentage of Participants Making at Least One Overall Error at Visit 1-Primary Device Comparisons | 55 Percentage of participants |
| Relvar Ellipta+LAMA | Percentage of Participants Making at Least One Overall Error at Visit 1-Primary Device Comparisons | 34 Percentage of participants |
| Symbicort Turbuhaler+LAMA | Percentage of Participants Making at Least One Overall Error at Visit 1-Primary Device Comparisons | 70 Percentage of participants |
| Seretide Diskus+LAMA | Percentage of Participants Making at Least One Overall Error at Visit 1-Primary Device Comparisons | 66 Percentage of participants |
p-value: 0.04595% CI: [1.018, 5.676]Regression, Logistic
p-value: 0.17295% CI: [0.77, 4.319]Regression, Logistic
p-value: 0.01695% CI: [1.229, 7.272]Regression, Logistic
p-value: 0.17995% CI: [0.775, 3.937]Regression, Logistic
p-value: 0.6995% CI: [0.509, 2.775]Regression, Logistic
p-value: 0.00495% CI: [1.48, 7.639]Regression, Logistic
p-value: 0.01295% CI: [1.264, 6.42]Regression, Logistic
p-value: <0.00195% CI: [1.986, 10.791]Regression, Logistic
p-value: 0.08195% CI: [0.916, 4.528]Regression, Logistic
p-value: 195% CI: [0.438, 2.283]Regression, Logistic
Secondary
Percentage of Participants Making at Least One Overall Error at Visit 2-Dual Device Comparisons (Relvar Ellipta DPI Versus All ICS/LABA DPIs With a LAMA Second DPI)
Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on correct use of inhalers. Any error made by the participant was recorded by HCP in the checklist. Checklist of instructions for correct use were based on 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 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.
Time frame: Week 6
Population: ITT Population. Only those participants with data available at Visit 2 were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Relvar Ellipta | Percentage of Participants Making at Least One Overall Error at Visit 2-Dual Device Comparisons (Relvar Ellipta DPI Versus All ICS/LABA DPIs With a LAMA Second DPI) | 12 Percentage of participants |
| Symbicort Turbuhaler | Percentage of Participants Making at Least One Overall Error at Visit 2-Dual Device Comparisons (Relvar Ellipta DPI Versus All ICS/LABA DPIs With a LAMA Second DPI) | 29 Percentage of participants |
p-value: 0.05295% CI: [0.993, 6.407]Regression, Logistic
p-value: 0.02995% CI: [1.107, 6.862]Regression, Logistic
Secondary
Percentage of Participants Making at Least One Overall Error at Visit 2-Dual Device Comparisons (Relvar Ellipta DPI Versus Relvar Ellipta With Any Other LAMA)
Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. 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.
Time frame: Week 6
Population: ITT Population. Only those participants with data available at Visit 2 were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Relvar Ellipta | Percentage of Participants Making at Least One Overall Error at Visit 2-Dual Device Comparisons (Relvar Ellipta DPI Versus Relvar Ellipta With Any Other LAMA) | 12 Percentage of participants |
| Symbicort Turbuhaler | Percentage of Participants Making at Least One Overall Error at Visit 2-Dual Device Comparisons (Relvar Ellipta DPI Versus Relvar Ellipta With Any Other LAMA) | 16 Percentage of participants |
p-value: 0.47295% CI: [0.492, 4.633]Regression, Logistic
p-value: 0.55395% CI: [0.459, 4.283]Regression, Logistic
Secondary
Percentage of Participants Making at Least One Overall Error at Visit 2-Dual Device Comparisons (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI)
Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. 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 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.
Time frame: Week 6
Population: ITT Population. Only those participants with data available at Visit 2 were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Relvar Ellipta | Percentage of Participants Making at Least One Overall Error at Visit 2-Dual Device Comparisons (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI) | 14 Percentage of participants |
| Symbicort Turbuhaler | Percentage of Participants Making at Least One Overall Error at Visit 2-Dual Device Comparisons (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI) | 33 Percentage of participants |
| Seretide Diskus | Percentage of Participants Making at Least One Overall Error at Visit 2-Dual Device Comparisons (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI) | 34 Percentage of participants |
p-value: 0.02495% CI: [1.123, 5.276]Regression, Logistic
p-value: 0.03595% CI: [1.061, 5.376]Regression, Logistic
p-value: 0.00395% CI: [1.434, 5.819]Regression, Logistic
p-value: 0.00395% CI: [1.461, 6.055]Regression, Logistic
Secondary
Percentage of Participants Making at Least One Overall Error at Visit 2 in Primary DPI (Relvar Ellipta DPI Versus All ICS/LABA DPIs With a LAMA Second DPI)
Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. 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 listed in PILs for the respective DPI. The errors 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 PIL. Overall errors is the combination of critical and non-critical errors. The percentage of participants making 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.
Time frame: Week 6
Population: ITT Population. Only those participants with data available at Visit 2 were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Relvar Ellipta | Percentage of Participants Making at Least One Overall Error at Visit 2 in Primary DPI (Relvar Ellipta DPI Versus All ICS/LABA DPIs With a LAMA Second DPI) | 19 Percentage of participants |
| Symbicort Turbuhaler | Percentage of Participants Making at Least One Overall Error at Visit 2 in Primary DPI (Relvar Ellipta DPI Versus All ICS/LABA DPIs With a LAMA Second DPI) | 12 Percentage of participants |
p-value: 0.40495% CI: [0.578, 3.905]Regression, Logistic
p-value: 0.3395% CI: [0.625, 4.05]Regression, Logistic
Secondary
Percentage of Participants Making at Least One Overall Error at Visit 2 in Primary DPI (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI
Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. 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 listed in PILs for the respective DPI. The errors 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 PIL. Overall errors is the combination of critical and non-critical errors. The percentage of participants making 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. .
Time frame: Week 6
Population: ITT Population. Only those participants with data available at Visit 2 were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Relvar Ellipta | Percentage of Participants Making at Least One Overall Error at Visit 2 in Primary DPI (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI | 13 Percentage of participants |
| Symbicort Turbuhaler | Percentage of Participants Making at Least One Overall Error at Visit 2 in Primary DPI (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI | 25 Percentage of participants |
| Seretide Diskus | Percentage of Participants Making at Least One Overall Error at Visit 2 in Primary DPI (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI | 27 Percentage of participants |
p-value: 0.18995% CI: [0.761, 3.968]Regression, Logistic
p-value: 0.08695% CI: [0.901, 4.799]Regression, Logistic
p-value: 0.08295% CI: [0.918, 4.142]Regression, Logistic
p-value: 0.01895% CI: [1.161, 5.024]Regression, Logistic
Secondary
Percentage of Participants Making at Least One Overall Error at Visit 2-Primary Device Comparisons
Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. 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 the primary DPI is presented.
Time frame: Week 6
Population: ITT Population. Only those participants with data available at Visit 2 were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Relvar Ellipta | Percentage of Participants Making at Least One Overall Error at Visit 2-Primary Device Comparisons | 12 Percentage of participants |
| Symbicort Turbuhaler | Percentage of Participants Making at Least One Overall Error at Visit 2-Primary Device Comparisons | 35 Percentage of participants |
| Seretide Diskus | Percentage of Participants Making at Least One Overall Error at Visit 2-Primary Device Comparisons | 27 Percentage of participants |
| Spiriva Handihaler | Percentage of Participants Making at Least One Overall Error at Visit 2-Primary Device Comparisons | 36 Percentage of participants |
| Incruse/Anoro Ellipta | Percentage of Participants Making at Least One Overall Error at Visit 2-Primary Device Comparisons | 8 Percentage of participants |
| Ultibro/Seebri Breezhaler | Percentage of Participants Making at Least One Overall Error at Visit 2-Primary Device Comparisons | 32 Percentage of participants |
| Relvar Ellipta+LAMA | Percentage of Participants Making at Least One Overall Error at Visit 2-Primary Device Comparisons | 14 Percentage of participants |
| Symbicort Turbuhaler+LAMA | Percentage of Participants Making at Least One Overall Error at Visit 2-Primary Device Comparisons | 14 Percentage of participants |
| Seretide Diskus+LAMA | Percentage of Participants Making at Least One Overall Error at Visit 2-Primary Device Comparisons | 28 Percentage of participants |
p-value: 0.0295% CI: [1.218, 9.961]Regression, Logistic
p-value: 0.14395% CI: [0.757, 6.895]Regression, Logistic
p-value: 0.00695% CI: [1.615, 17.187]Regression, Logistic
p-value: 0.00995% CI: [1.478, 14.666]Regression, Logistic
p-value: 0.67995% CI: [0.405, 4.005]Regression, Logistic
p-value: 0.0195% CI: [1.372, 10.544]Regression, Logistic
p-value: 0.08395% CI: [0.886, 7.369]Regression, Logistic
p-value: 0.00295% CI: [1.89, 18.611]Regression, Logistic
p-value: 0.00795% CI: [1.556, 15.612]Regression, Logistic
p-value: 0.74695% CI: [0.385, 3.788]Regression, Logistic