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This is a randomised, open-label, placebo, crossover, multicentre study with a single visit. The study will comprise five sub-studies. Subjects will receive inactive treatment (placebo) via the ELLIPTA® inhaler and one of the other inhaler devices depending on the sub-study they are randomised to. Only subjects who are naïve to the ELLIPTA inhaler and to one of the other inhaler devices that will be used in this study will be included. Furthermore, subjects who are naïve to the BREEZEHALER® and HANDIHALER® inhalers must be naïve to all other inhaler devices that requires a capsule. The study will be conducted in the UK and the Netherlands, and comprises one visit only. A sufficient number of subjects (at least 600) with COPD will be screened and 570 will be randomised to one of five sub-studies. Eligible subjects will be allocated to one of the sub-studies depending on their experience of using the other inhaler (i.e., depending on which other inhaler they are naïve to).
This study is designed to assess the proportion of COPD subjects making critical and overall (i.e., critical and non-critical errors) errors in using ELLIPTA inhaler and other commercially available inhaler devices such as the TURBUHALER®, HANDIHALER, BREEZHALER, MDI and DISKUS®/ACCUHALER® inhalers. This study will also assess the 'ease of use' and preference between the ELLIPTA inhaler and the other commercially available inhaler devices.
ELLIPTA, DISKUS, and ACCUHALER are registered trademarks of the GSK group of companies. TURBUHALER is a registered trademark of AstraZeneca. HANDIHALER is a registered trademark of Boehringer Ingelheim Pharma GmbH & Co. KG. BREEZHALER is a registered trademark of Novartis AG.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sub-Study 1 | Experimental | Subjects will be randomized to either use ELLIPTA inhaler first and then DISKUS/ACCUHALER inhaler or use DISKUS/ACCUHALER inhaler first and then ELLIPTA inhaler. |
|
| Sub-Study 2 | Experimental | Subjects will be randomized to either use ELLIPTA inhaler first and then MDI inhaler or use MDI inhaler first and then ELLIPTA inhaler. |
|
| Sub-Study 3 | Experimental | Subjects will be randomized to either use ELLIPTA inhaler first and then TURBUHALER inhaler or use TURBUHALER inhaler first and then ELLIPTA. |
|
| Sub-Study 4 | Experimental | Subjects will be randomized to either use ELLIPTA inhaler first and then HANDIHALER inhaler or use HANDIHALER inhaler first and then ELLIPTA inhaler. |
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| Sub-Study 5 | Experimental | Subjects will be randomized to either use ELLIPTA inhaler first and then BREEZEHALER inhaler or use BREEZEHALER inhaler first and then ELLIPTA inhaler. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ELLIPTA | Device | Dry powder inhaler (placebo) with two blister strips. One placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Made at Least One Critical Error After Reading the Patient Information Leaflet | A critical error was defined as an error that was most likely to result in no or only minimal medication being inhaled. The errors considered as critical errors while handling the inhaler devices were failed to open cover, lever was not pushed back, shook the device after dose preparation, exhaled directly into mouthpiece, no seal by the lips round the mouthpiece during the inhalation. As per the crossover study design participants received placebo via the ELLIPTA inhaler first and then non-ELLIPTA inhaler or non-ELLIPTA inhaler first and then ELLIPTA on Day 1. The percentage of participants who made at least one critical error was reported for each inhaler regardless sequence. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Made at Least One Overall Error After Reading the Patient Information Leaflet | An overall error includes a critical and non-critical error. Any error made by the participants while demonstrating the use of the inhaler after reading the patient instruction leaflet was recorded by health care professional (HCP). The percentage of participants who made at least one overall error was reported. As per the crossover study design participants received placebo via the ELLIPTA inhaler first and then non-ELLIPTA inhaler or non-ELLIPTA inhaler first and then ELLIPTA on Day 1. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Almere Stad | 1311 RL | Netherlands | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27883002 | Derived | van der Palen J, Thomas M, Chrystyn H, Sharma RK, van der Valk PD, Goosens M, Wilkinson T, Stonham C, Chauhan AJ, Imber V, Zhu CQ, Svedsater H, Barnes NC. A randomised open-label cross-over study of inhaler errors, preference and time to achieve correct inhaler use in patients with COPD or asthma: comparison of ELLIPTA with other inhaler devices. NPJ Prim Care Respir Med. 2016 Nov 24;26:16079. doi: 10.1038/npjpcrm.2016.79. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 200301 | Statistical Analysis Plan | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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A total of 575 participants were enrolled in the study out of them 8 failed in screening and remaining 567 were randomized and included in intent to treat population. Participants were allocated to a particular sub-study depending on their experience of using the other inhaler (i.e., depending on which other inhaler they were naïve to using).
The study was conducted between 28 August 2014 and 31 July 2015 at 8 centers, 6 in the Netherlands and 2 in the United Kingdom. Only participants who were naïve to the ELLIPTA inhaler and to one of the other inhaler devices that was used in this study were included.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sub-study 1:ELLIPTA Versus (Vs) DISKUS/ACCUHALER | Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily Chronic Obstructive Pulmonary Disease (COPD) maintenance and other medication(s) during the study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| DISKUS/ACCUHALER | Device | Placebo inhaler with one blister strip containing lactose monohydrate. |
|
| MDI | Device | Placebo inhaler containing propellant (1,1,1, 2-Tetrafluoroethane). |
|
| TURBUHALER | Device | Placebo inhaler containing lactose monohydrate. |
|
| HANDIHALER | Device | Placebo inhaler containing lactose monohydrate in a capsule. |
|
| BREEZEHALER | Device | Placebo inhaler containing lactose monohydrate in a capsule. |
|
| Day 1 |
| Percentage of Participants Making at Least One Critical Error After the First Instruction From the HCP | A critical error was defined as an error that was most likely to result in no or only minimal medication being inhaled. The errors considered as critical errors while handling the inhaler devices were failed to open cover, lever was not pushed back, shook the device after dose preparation, exhaled directly into mouthpiece, no seal by the lips round the mouthpiece during the inhalation. As per the crossover study design participants received placebo via the ELLIPTA inhaler first and then non-ELLIPTA inhaler or non-ELLIPTA inhaler first and then ELLIPTA on Day 1. If the participant made any error while demonstrating the use of the inhaler after reading the patient instruction leaflet, the HCP demonstrated the correct usage of the inhaler to the participant. The participants were then asked to demonstrate inhaler use again. If any further critical error were made by the participant, the error were recorded by HCP. | Day 1 |
| Percentage of Participants Making at Least One Overall Error After the First Instruction From the HCP | An overall error includes a critical and non-critical error. If the participant made any error while demonstrating the use of the inhaler after reading the patient instruction leaflet, the HCP demonstrated the correct usage of the inhaler to the participant. The participants were then asked to demonstrate inhaler use again. If any further error was made by the participant was recorded by HCP. | Day 1 |
| Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique | If the participant made any error while demonstrating the use of the first inhaler after reading the patient instruction leaflet, the HCP demonstrated the correct usage of the inhaler to the participant. The participant was then asked to demonstrate inhaler use again. Any errors made by the participant were recorded by the HCP. The same procedure was repeated if the participant continues to make errors in the use of the inhaler. In total, the HCP demonstrated the use of the inhaler up to three times. Same procedure was followed for second inhaler. The number of participants who demonstrated the adequate inhalation technique after third time instructions from HCP was reported. | Day 1 |
| Percentage of Participants Who Overall Preferred the ELLIPTA Device Compared to Non-ELLIPTA Inhalers as Assessed by the Preference Questionnaire | After completing the demonstration procedures of the inhalers, the HCP asked the participant a number of questions from preference questionnaire. Preference questionnaire consisted of eight questions related to both inhalers used during the study. Each question had one response to choose from 3 preference options (Other inhaler device, ELLIPTA inhaler device and No preference). The number of participants who overall preferred the ELLIPTA device compared to non-ELLIPTA inhalers (First question in the preference questionnaire) were reported. | Day 1 |
| Percentage of Participants Who Overall Found the ELLIPTA Device Easy to Use Compared With Non-ELLIPTA Inhalers as Assessed by the Ease of Use Questionnaire | After completing the demonstration procedures of the inhalers, the HCP asked the participant a number of questions from ease of use questionnaire. Ease of use questionnaire consisted of six questions each for ELLIPTA inhaler and the other inhaler under study. Each question had one response to choose from 5 options of ease of use (Very easy, easy, neutral, difficult and very difficult). Based upon the response given by the participants the number of participants who rated ease of use higher for ELLIPTA, higher for non- ELLIPTA, or rated the same were reported | Day 1 |
| Beek |
| 6191 JW |
| Netherlands |
| GSK Investigational Site | Enschede | 7513 ER | Netherlands |
| GSK Investigational Site | Kloosterhaar | 7694 AC | Netherlands |
| GSK Investigational Site | Nijverdal | 7442 LS | Netherlands |
| GSK Investigational Site | Zutphen | 7207 AE | Netherlands |
| GSK Investigational Site | Portsmouth | PO6 3LY | United Kingdom |
| GSK Investigational Site | Southampton | SO16 6YD | United Kingdom |
For additional information about this study please refer to the GSK Clinical Study Register |
| 200301 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 200301 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 200301 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 200301 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 200301 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 200301 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FG001 |
| Sub-study 2: ELLIPTA Vs Metered-dose Inhaler (MDI) |
Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study. |
| FG002 | Sub-study 3: ELLIPTA Vs TURBUHALER | Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study. |
| FG003 | Sub-study 4: ELLIPTA Vs HANDIHALER | Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study. |
| FG004 | Sub-study 5: ELLIPTA Vs BREEZHALER | Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER | Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study. |
| BG001 | Sub-study 2: ELLIPTA Vs MDI | Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study. |
| BG002 | Sub-study 3: ELLIPTA Vs TURBUHALER | Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study. |
| BG003 | Sub-study 4: ELLIPTA Vs HANDIHALER | Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study. |
| BG004 | Sub-study 5: ELLIPTA Vs BREEZHALER | Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex/Gender, Customized | Number | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Made at Least One Critical Error After Reading the Patient Information Leaflet | A critical error was defined as an error that was most likely to result in no or only minimal medication being inhaled. The errors considered as critical errors while handling the inhaler devices were failed to open cover, lever was not pushed back, shook the device after dose preparation, exhaled directly into mouthpiece, no seal by the lips round the mouthpiece during the inhalation. As per the crossover study design participants received placebo via the ELLIPTA inhaler first and then non-ELLIPTA inhaler or non-ELLIPTA inhaler first and then ELLIPTA on Day 1. The percentage of participants who made at least one critical error was reported for each inhaler regardless sequence. | Modified Intent-to-Treat Population comprised of all participants in the Intent-to-Treat Population who completed demonstration of using both study inhaler devices after reading patient information leaflet. | Posted | Number | Percentage of participants | Day 1 |
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| Secondary | Percentage of Participants Who Made at Least One Overall Error After Reading the Patient Information Leaflet | An overall error includes a critical and non-critical error. Any error made by the participants while demonstrating the use of the inhaler after reading the patient instruction leaflet was recorded by health care professional (HCP). The percentage of participants who made at least one overall error was reported. As per the crossover study design participants received placebo via the ELLIPTA inhaler first and then non-ELLIPTA inhaler or non-ELLIPTA inhaler first and then ELLIPTA on Day 1. | Modified Intent-to-Treat Population. | Posted | Number | Percentage of participants | Day 1 |
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| Secondary | Percentage of Participants Making at Least One Critical Error After the First Instruction From the HCP | A critical error was defined as an error that was most likely to result in no or only minimal medication being inhaled. The errors considered as critical errors while handling the inhaler devices were failed to open cover, lever was not pushed back, shook the device after dose preparation, exhaled directly into mouthpiece, no seal by the lips round the mouthpiece during the inhalation. As per the crossover study design participants received placebo via the ELLIPTA inhaler first and then non-ELLIPTA inhaler or non-ELLIPTA inhaler first and then ELLIPTA on Day 1. If the participant made any error while demonstrating the use of the inhaler after reading the patient instruction leaflet, the HCP demonstrated the correct usage of the inhaler to the participant. The participants were then asked to demonstrate inhaler use again. If any further critical error were made by the participant, the error were recorded by HCP. | Modified Intent-to-Treat Population | Posted | Number | Percentage of participants | Day 1 |
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| Secondary | Percentage of Participants Making at Least One Overall Error After the First Instruction From the HCP | An overall error includes a critical and non-critical error. If the participant made any error while demonstrating the use of the inhaler after reading the patient instruction leaflet, the HCP demonstrated the correct usage of the inhaler to the participant. The participants were then asked to demonstrate inhaler use again. If any further error was made by the participant was recorded by HCP. | Modified Intent-to-Treat Population. | Posted | Number | Percentage of participants | Day 1 |
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| Secondary | Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique | If the participant made any error while demonstrating the use of the first inhaler after reading the patient instruction leaflet, the HCP demonstrated the correct usage of the inhaler to the participant. The participant was then asked to demonstrate inhaler use again. Any errors made by the participant were recorded by the HCP. The same procedure was repeated if the participant continues to make errors in the use of the inhaler. In total, the HCP demonstrated the use of the inhaler up to three times. Same procedure was followed for second inhaler. The number of participants who demonstrated the adequate inhalation technique after third time instructions from HCP was reported. | Modified Intent-to-Treat Population | Posted | Number | Participants | Day 1 |
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| Secondary | Percentage of Participants Who Overall Preferred the ELLIPTA Device Compared to Non-ELLIPTA Inhalers as Assessed by the Preference Questionnaire | After completing the demonstration procedures of the inhalers, the HCP asked the participant a number of questions from preference questionnaire. Preference questionnaire consisted of eight questions related to both inhalers used during the study. Each question had one response to choose from 3 preference options (Other inhaler device, ELLIPTA inhaler device and No preference). The number of participants who overall preferred the ELLIPTA device compared to non-ELLIPTA inhalers (First question in the preference questionnaire) were reported. | Modified Intent-to-Treat population. Only participants who completed the questionnaire were included in the analysis. | Posted | Number | Percentage of participants | Day 1 |
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| Secondary | Percentage of Participants Who Overall Found the ELLIPTA Device Easy to Use Compared With Non-ELLIPTA Inhalers as Assessed by the Ease of Use Questionnaire | After completing the demonstration procedures of the inhalers, the HCP asked the participant a number of questions from ease of use questionnaire. Ease of use questionnaire consisted of six questions each for ELLIPTA inhaler and the other inhaler under study. Each question had one response to choose from 5 options of ease of use (Very easy, easy, neutral, difficult and very difficult). Based upon the response given by the participants the number of participants who rated ease of use higher for ELLIPTA, higher for non- ELLIPTA, or rated the same were reported | Modified Intent-to-Treat Population. | Posted | Number | Percentage of participants | Day 1 |
|
Adverse events and serious adverse events were collected from the start of study treatment (Day 1) and until the follow up contact.
Intent-to-Treat Population comprised of all participants who had been randomized and used at least one study inhaler after reading patient information leaflet.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER | Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study. | 0 | 171 | 0 | 171 | ||
| EG001 | Sub-study 2: ELLIPTA Vs MDI | Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study. | 0 | 80 | 0 | 80 | ||
| EG002 | Sub-study 3: ELLIPTA Vs TURBUHALER | Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study. | 0 | 100 | 0 | 100 | ||
| EG003 | Sub-study 4: ELLIPTA Vs HANDIHALER | Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study. | 0 | 118 | 0 | 118 | ||
| EG004 | Sub-study 5: ELLIPTA Vs BREEZHALER | Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study. | 0 | 98 | 0 | 98 |
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GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
|
| Unknown |
|
| Asian - East Asian Heritage |
|
| Asian - South East Asian Heritage |
|
| Native Hawaiian or Other Pacific Islander |
|
| White - White/Caucasian/European Heritage |
|
| Unknown |
|
| Error with only non-ELLIPTA inhaler |
|
| Error with both inhalers |
|
| <0.001 |
Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using MDI |
| 95 |
| Superiority or Other |
| Cochran-Mantel-Haenszel | <0.001 | Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using TURBUHALER | 95 | Superiority or Other |
| Cochran-Mantel-Haenszel | <0.001 | Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using HANDIHALER | 95 | Superiority or Other |
| Cochran-Mantel-Haenszel | <0.001 | Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using BREEZHALER | 95 | Superiority or Other |
Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study. |
| OG003 | Sub-study 4: ELLIPTA Vs HANDIHALER | Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study. |
| OG004 | Sub-study 5: ELLIPTA Vs BREEZHALER | Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study. |
|
|
|
Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
| OG002 | Sub-study 3: ELLIPTA Vs TURBUHALER | Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study. |
| OG003 | Sub-study 4: ELLIPTA Vs HANDIHALER | Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study. |
| OG004 | Sub-study 5: ELLIPTA Vs BREEZHALER | Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study. |
|
|
|
Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
| OG003 | Sub-study 4: ELLIPTA Vs HANDIHALER | Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study. |
| OG004 | Sub-study 5: ELLIPTA Vs BREEZHALER | Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study. |
|
|
|
| OG002 | Sub-study 3: ELLIPTA Vs TURBUHALER | Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study. |
| OG003 | Sub-study 4: ELLIPTA Vs HANDIHALER | Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study. |
| OG004 | Sub-study 5: ELLIPTA Vs BREEZHALER | Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study. |
|
|
|
| OG002 | Sub-study 3: ELLIPTA Vs TURBUHALER | Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study. |
| OG003 | Sub-study 4: ELLIPTA Vs HANDIHALER | Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study. |
| OG004 | Sub-study 5: ELLIPTA Vs BREEZHALER | Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study. |
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| OG002 |
| Sub-study 3: ELLIPTA Vs TURBUHALER |
Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study. |
| OG003 | Sub-study 4: ELLIPTA Vs HANDIHALER | Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study. |
| OG004 | Sub-study 5: ELLIPTA Vs BREEZHALER | Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study. |
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