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This is a randomized, multi-centre, open-label, placebo-device, cross-over study, with a 2x2 complete block design in subjects with chronic obstructive pulmonary disease (COPD) to assess the benefits of delivering triple therapy using a single ELLIPTA dry powder inhaler (DPI) (closed triple therapy) versus delivering triple therapy using two different types of DPI (open triple therapy). The primary objective of the study is to evaluate the proportion of COPD subjects who make critical errors when using a single ELLIPTA DPI versus those using combinations of DISKUS® with HANDIHALER®, or TURBUHALER® with HANDIHALER. At Visit 1, all subjects will demonstrate the use of ELLIPTA DPI, and HANDIHALER DPI in combination with either DISKUS DPI (in sub-study 1) or TURBUHALER DPI (in sub-study 2), based on the treatment sequences. At the end Visit 1, subjects will complete the inhaler preference questionnaire (PQ). There is no active treatment and subjects will continue to take their own prescribed COPD medication for the duration of the study. ELLIPTA and DISKUS are registered trademarks of the GSK group of companies; TURBUHALER is a registered trademark of AstraZeneca and HANDIHALER is a registered trademark of Boehringer Ingelheim Pharma GmbH & Co. KG.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sub-study 1 : ELLIPTA followed by DISKUS+ HANDIHALER +PQ1 | Experimental | In this sequence, subjects will be randomized to use ELLIPTA inhaler in period 1 and then DISKUS + HANDIHALER in period 2. At the end of Visit 1, subjects will complete version 1 of the PQ (PQ1) |
|
| Sub-study 1 : DISKUS + HANDIHALER followed by ELLIPTA+PQ2 | Experimental | In this sequence, subjects will be randomized to use DISKUS + HANDIHALER in period 1 and then ELLIPTA in period 2. At the end of Visit 1, subjects will complete version 2 of the PQ (PQ2) |
|
| Sub-study 1 : ELLIPTA followed by DISKUS+ HANDIHALER +PQ2 | Experimental | In this sequence, subjects will be randomized to use ELLIPTA inhaler in period 1 and then DISKUS + HANDIHALER in period 2. At the end of Visit 1, subjects will complete PQ2 |
|
| Sub-study 1 : DISKUS + HANDIHALER followed by ELLIPTA+PQ1 | Experimental | In this sequence, subjects will be randomized to use DISKUS + HANDIHALER in period 1 and then ELLIPTA in period 2. At the end of Visit 1, subjects will complete PQ1 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo ELLIPTA | Device | It is a dry powder inhaler device that can hold two individual blisters: 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 Making at Least One Critical Error After Reading the Patient Information Leaflets (PIL) | Participants were provided with the relevant section of the PIL, explaining correct use, for each DPI they were to be tested on. A critical error was defined as an error that was most likely to result in no, or a significantly reduced amount, of medication being inhaled by the participant. After reading the PIL for each DPI to be tested, participants demonstrated the DPI and critical errors made by the participants while using each DPI were recorded by the Healthcare Professional (HCP) on the checklists provided. Percentage of participants making at least one critical error after reading PIL were reported. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Making at Least One Critical Error After the First Instruction From the HCP | Participants were provided with the relevant section of the PIL, explaining correct use, for each DPI they were to be tested on. A critical error was defined as an error that was most likely to result in no, or a significantly reduced amount, of medication being inhaled by the participant. After reading PIL for each DPI to be tested, participants demonstrated the DPI and errors made by the participants while using each DPI were recorded by the HCP on the checklists provided. If a participant made errors while demonstrating DPI, HCP provided instruction on the correct use of the DPI. The participant then repeated the demonstration of DPI use, and the HCP recorded the critical errors made on the checklists. Percentage of participants making at least one critical error after the first instruction from the HCP were reported. |
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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 | Enschede | 7513 ER | Netherlands | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30174421 | Background | van der Palen J, Moeskops-van Beurden W, Dawson CM, James WY, Preece A, Midwinter D, Barnes N, Sharma R. A randomized, open-label, single-visit, crossover study simulating triple-drug delivery with Ellipta compared with dual inhaler combinations in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2018 Aug 21;13:2515-2523. doi: 10.2147/COPD.S169060. eCollection 2018. |
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A total of 160 participants were screened. Eighty were assigned to sub-study 1 and 80 to sub-study 2 according to naivety to inhalers in each sub-study. One participant in sub-study 2 withdrew consent prior to device assessment. Therefore 80 par in sub-study 1 and 79 par in sub-study 2 are included in the intent to treat population.
This is a randomized, multi-center, open-label, cross-over study comparing Placebo ELLIPTA Dry Power Inhaler (DPI) with either Placebo DISKUS DPI + Placebo Handihaler or Placebo Turbuhaler plus Placebo Handihaler to assess correct inhaler use. A total of 5 centers, 3 in the Netherlands and 2 in the United Kingdom participated in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | ELLIPTA/DISKUS+HandiHaler/Q1 | Participants received placebo via ELLIPTA in period 1 and DISKUS + HandiHaler in period 2, followed by preference questionnaire (PQ) 1. There was no active treatment and participants continued to take their own prescribed COPD medication for the duration of the study. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 18, 2017 | Mar 8, 2018 |
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| Substudy 2: ELLIPTA followed by TURBUHALER + HANDIHALER +PQ3 | Experimental | In this sequence, subjects will be randomized to use ELLIPTA inhaler in period 1 and then TURBUHALER + HANDIHALER in period 2. At the end of Visit 1, subjects will complete version 3 of the PQ (PQ3) |
|
| Substudy 2: TURBUHALER + HANDIHALER followed by ELLIPTA+PQ4 | Experimental | In this sequence, subjects will be randomized to use TURBUHALER + HANDIHALER inhaler in period 1 and then ELLIPTA in period 2. At the end of Visit 1, subjects will complete version 4 of the PQ (PQ4) |
|
| Substudy 2: ELLIPTA followed by TURBUHALER + HANDIHALER +PQ4 | Experimental | In this sequence, subjects will be randomized to use ELLIPTA inhaler in period 1 and then TURBUHALER + HANDIHALER in period 2. At the end of Visit 1, subjects will complete PQ4 |
|
| Substudy 2: TURBUHALER + HANDIHALER followed by ELLIPTA+PQ3 | Experimental | In this sequence, subjects will be randomized to use TURBUHALER + HANDIHALER inhaler in period 1 and then ELLIPTA in period 2. At the end of Visit 1, subjects will complete PQ3 |
|
| Placebo DISKUS | Device | It is a placebo dry powder inhaler with one blister strip containing lactose monohydrate. |
|
| Placebo TURBUHALER | Device | It is a placebo dry powder inhaler containing lactose monohydrate. |
|
| Placebo HANDIHALER | Device | Placebo capsules contain lactose monohydrate in the form of powder for oral inhalation, to be used with HANDIHALER device. |
|
| PQ1 | Other | Consists of 2 questions to assess subjects' preference of device attributes and dosing regimens. The 4 versions of the questionnaire ask the same questions, but differ in the ordering of inhalers in their responses. |
|
| PQ2 | Other | Consists of 2 questions to assess subjects' preference of device attributes and dosing regimens. The 4 versions of the questionnaire ask the same questions. |
|
| PQ3 | Other | Consists of 2 questions to assess subjects' preference of device attributes and dosing regimens. The 4 versions of the questionnaire ask the same questions. |
|
| PQ4 | Other | Consists of 2 questions to assess subjects' preference of device attributes and dosing regimens. The 4 versions of the questionnaire ask the same questions. |
|
| Day 1 |
| Percentage of Participants Making at Least One Critical Error After the Second Instruction From the HCP | Participants were provided with the relevant section of the PIL, explaining correct use, for each DPI they were to be tested on. A critical error was defined as an error that was most likely to result in no, or a significantly reduced amount, of medication being inhaled by the participant. After reading the PIL for each DPI to be tested, participants demonstrated the DPI and errors made by the participants while using each DPI were recorded by the HCP on the checklists provided. If a participant made an error while demonstrating DPI use after first instruction from the HCP, then the HCP provided instructions again on the correct use of the inhaler. The participant then demonstrated the DPI for one last time, and the HCP recorded the critical errors made on the checklists. Participants making at least one critical error after the second instruction from the HCP were reported. | Day 1 |
| Percentage of Participants Making at Least One Overall Error After Reading the PIL | Participants were provided with the relevant section of the PIL, explaining correct use, for each DPI they were to be tested on. Overall error was defined as an error including critical and non-critical errors made by the participants while demonstrating DPI use after reading the PIL. For each DPI to be tested, overall errors including critical and non-critical errors made by the participants while demonstrating DPI use after reading the PIL were recorded by the HCP on the checklists provided. Percentage of participants making at least one overall error after reading the PIL were reported. | Day 1 |
| Percentage of Participants Making at Least One Overall Error After the First Instruction From the HCP | For each DPI to be tested, overall errors including critical and non-critical errors made by the participants while demonstrating DPI use after reading the PIL following first instruction from the HCP were recorded by the HCP on the checklists provided. Percentage of participants making at least one overall error after the first instruction from the HCP were reported. | Day 1 |
| Percentage of Participants Making at Least One Overall Error After the Second Instruction From the HCP | For each DPI to be tested, overall errors including critical and non-critical errors made by the participants while demonstrating DPI use after reading the PIL following first, and second instruction from the HCP were recorded by the HCP on the checklists provided. Percentage of participants making at least one overall error after the second instruction from the HCP were reported. These statistics are only presented when the model has successfully converged. | Day 1 |
| Number of Participants With Instructions (0, 1 or 2 Times) From the HCP Which Are Needed to Demonstrate Correct Inhaler Use | In each sub-study, if the participant made error while demonstrating the use of the DPI after reading the PIL, the HCP demonstrated the correct usage instructions to the participant. The participant was then asked to demonstrate the DPI again. Any errors made were recorded by the HCP, and the same process was repeated one more time. In total, the HCP instructed the participants on the use of the DPI up to two times after which there were no assessment scheduled. Number of participants with instructions (0, 1 or 2) needed to demonstrate correct DPI use by the participants were reported. | Day 1 |
| The Median Time to Demonstrate Correct Inhaler Use (T1+T2) | For each DPI being tested, the total time taken from when participant started reading the PIL until when correct use was demonstrated (that is the time required to read PIL, and two attempts for correct use of DPI following instructions provided by the HCP ) was recorded. A participant who did not demonstrate correct use at the end of the time period was censored. The median time to demonstrate correct DPI use (minutes) is taken from the Kaplan-Meier analysis. If more than 50% of the data is censored therefore the median is not applicable. | Day 1 |
| Time Taken to Read the PIL and Demonstrate Correct Inhaler Use (T1) | For each DPI being tested, the time taken from when participant started reading the PIL until when correct use was demonstrated with no need of instructions by HCP was reported. A participant who did not demonstrate correct use at the end of the time period was censored. The median time to demonstrate correct DPI use (minutes) is taken from the Kaplan-Meier analysis. If more than 50% of the data is censored therefore the median is not applicable. | Day 1 |
| Time Taken to be Given Instruction by the HCP (up to 2 Times) on Use of the Inhaler and to Demonstrate Correct Inhaler Use (T2) | The time in minutes from when the HCP started to instruct participant for the correct use of DPI until correct use was demonstrated including maximum of two attempts only, was recorded. A participant who did not demonstrate correct use at the end of the time period was censored. Participants who demonstrated correct use after reading the PIL (T1) were included with a time of 0 for T2. The median time to demonstrate correct DPI use (minutes) is taken from the Kaplan-Meier analysis. If more than 50% of the data is censored then the median is not applicable. Participants who demonstrated correct use after reading the PIL are included with T2=0. | Day 1 |
| Number of Participants With Treatment Preference Based on Responses to the Preference Questionnaire, Which Considered the Number of Steps Required to Take the COPD Medication | Participants demonstrated the use of ELLIPTA, and depending on the substudy DISKUS plus HandiHaler or Turbuhaler plus Handihaler. At the end of Visit 1, participants completed specific versions of the inhaler PQ (PQ1, PQ2, PQ3 or PQ4) according to the questionnaire they were randomized to. Participants assessed the inhaler preference based on the number of steps needed to take the COPD medication. Participants checked the response from the choice of ELLIPTA, DISKUS + HandiHaler (sub-study 1), Turbuhaler + Handihaler (sub-study 2) and No Preference. Number of participants with treatment preference based on responses to the preference questionnaire were reported. | Day 1 |
| Number of Participants With Treatment Preference Based on Responses to the Preference Questionnaire, Which Considered Overall Treatment Preference | Participants demonstrated the use of ELLIPTA, and depending on the substudy DISKUS plus HandiHaler or Turbuhaler plus Handihaler. At the end of Visit 1, participants completed specific versions of the inhaler PQ (PQ1, PQ2, PQ3 or PQ4) according to the questionnaire they were randomized to. Participants assessed the inhaler preference based on overall treatment preference. Participants checked the response from the choice of ELLIPTA, DISKUS + HandiHaler (sub-study 1), Turbuhaler + Handihaler (sub-study 2) and No Preference. Number of participants with treatment preference based on responses to the preference questionnaire were reported. | Day 1 |
| Nijverdal |
| 7442 LS |
| Netherlands |
| GSK Investigational Site | Rotterdam | 3051 GV | Netherlands |
| GSK Investigational Site | London | EC1M 6BQ | United Kingdom |
| GSK Investigational Site | London | NW10 7EW | United Kingdom |
| ELLIPTA/DISKUS+HandiHaler/Q2 |
Participants received placebo via ELLIPTA in period 1 and DISKUS + HandiHaler in period 2, followed by PQ2. There was no active treatment and participants continued to take their own prescribed COPD medication for the duration of the study. |
| FG002 | DISKUS+HandiHaler/ELLIPTA/Q1 | Participants received placebo via DISKUS + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ1 respectively. There was no active treatment and participants continued to take their own prescribed COPD medication for the duration of the study. |
| FG003 | DISKUS+HandiHaler/ELLIPTA/Q2 | Participants received placebo via DISKUS + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ2. There was no active treatment and participants continued to take their own prescribed COPD medication for the duration of the study. |
| FG004 | ELLIPTA/Turbuhaler+HandiHaler/Q3 | Participants received placebo via ELLIPTA in period 1 and Turbuhaler + HandiHaler in period 2, followed by PQ3. There was no active treatment and participants continued to take their own prescribed COPD medication for the duration of the study. |
| FG005 | ELLIPTA/Turbuhaler+HandiHaler/Q4 | Participants received placebo via ELLIPTA in period 1 and Turbuhaler + HandiHaler in period 2, followed by PQ4. There was no active treatment and participants continued to take their own prescribed COPD medication for the duration of the study. |
| FG006 | Turbuhaler+HandiHaler/ELLIPTA/Q3 | Participants received placebo via Turbuhaler + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ3. There was no active treatment and participants continued to take their own prescribed COPD medication for the duration of the study. |
| FG007 | Turbuhaler+HandiHaler/ELLIPTA/Q4 | Participants received placebo via Turbuhaler + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ4. There was no active treatment and participants continued to take their own prescribed COPD medication for the duration of the study. |
| COMPLETED |
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| NOT COMPLETED |
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Intent-to-Treat Population comprised of all randomized participants who made at least one critical error assessment from one treatment option device. One participant withdrew consent prior to device assessment in Sub-study 2 and only 79 participants were included in Intent-to-Treat Population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sub Study 1: ELLIPTA vs DISKUS + HandiHaler | Participants received placebo via one of the following devices: ELLIPTA® DPI or DISKUS® DPI in combination with HANDIHALER® DPI based on the following four sequences. The sequences also include the preference questionnaire version: A (ELLIPTA in period 1 and DISKUS + HandiHaler in period 2,followed by PQ1), B (DISKUS + HandiHaler in period 1 and ELLIPTA in period 2,followed by PQ2), C (ELLIPTA in period 1 and DISKUS + HandiHaler in period 2, followed by PQ2), D (DISKUS + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ1) respectively. There was no active treatment and participants continued to take their own prescribed COPD medication for the duration of the study. |
| BG001 | Sub Study 2: ELLIPTA vs Turbuhaler + HandiHaler | Participants received placebo via one of the following devices: ELLIPTA DPI or TURBUHALER® DPI in combination with HANDIHALER DPI based on the following four sequences. The sequences also include the preference questionnaire version: : E (ELLIPTA in period 1 and Turbuhaler + HandiHaler in period 2, followed by PQ3), F (Turbuhaler + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ4), G (ELLIPTA in period 1 and Turbuhaler + HandiHaler in period 2, followed by PQ4), H (Turbuhaler + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ3) respectively. There was no active treatment and participants continued to take their own prescribed COPD medication for the duration of the study. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 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 Making at Least One Critical Error After Reading the Patient Information Leaflets (PIL) | Participants were provided with the relevant section of the PIL, explaining correct use, for each DPI they were to be tested on. A critical error was defined as an error that was most likely to result in no, or a significantly reduced amount, of medication being inhaled by the participant. After reading the PIL for each DPI to be tested, participants demonstrated the DPI and critical errors made by the participants while using each DPI were recorded by the Healthcare Professional (HCP) on the checklists provided. Percentage of participants making at least one critical error after reading PIL were reported. | 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 | Participants were provided with the relevant section of the PIL, explaining correct use, for each DPI they were to be tested on. A critical error was defined as an error that was most likely to result in no, or a significantly reduced amount, of medication being inhaled by the participant. After reading PIL for each DPI to be tested, participants demonstrated the DPI and errors made by the participants while using each DPI were recorded by the HCP on the checklists provided. If a participant made errors while demonstrating DPI, HCP provided instruction on the correct use of the DPI. The participant then repeated the demonstration of DPI use, and the HCP recorded the critical errors made on the checklists. Percentage of participants making at least one critical error after the first instruction from the HCP were reported. | 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 Second Instruction From the HCP | Participants were provided with the relevant section of the PIL, explaining correct use, for each DPI they were to be tested on. A critical error was defined as an error that was most likely to result in no, or a significantly reduced amount, of medication being inhaled by the participant. After reading the PIL for each DPI to be tested, participants demonstrated the DPI and errors made by the participants while using each DPI were recorded by the HCP on the checklists provided. If a participant made an error while demonstrating DPI use after first instruction from the HCP, then the HCP provided instructions again on the correct use of the inhaler. The participant then demonstrated the DPI for one last time, and the HCP recorded the critical errors made on the checklists. Participants making at least one critical error after the second instruction from the HCP were reported. | 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 Reading the PIL | Participants were provided with the relevant section of the PIL, explaining correct use, for each DPI they were to be tested on. Overall error was defined as an error including critical and non-critical errors made by the participants while demonstrating DPI use after reading the PIL. For each DPI to be tested, overall errors including critical and non-critical errors made by the participants while demonstrating DPI use after reading the PIL were recorded by the HCP on the checklists provided. Percentage of participants making at least one overall error after reading the PIL were reported. | 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 | For each DPI to be tested, overall errors including critical and non-critical errors made by the participants while demonstrating DPI use after reading the PIL following first instruction from the HCP were recorded by the HCP on the checklists provided. Percentage of participants making at least one overall error after the first instruction from the HCP were reported. | 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 Second Instruction From the HCP | For each DPI to be tested, overall errors including critical and non-critical errors made by the participants while demonstrating DPI use after reading the PIL following first, and second instruction from the HCP were recorded by the HCP on the checklists provided. Percentage of participants making at least one overall error after the second instruction from the HCP were reported. These statistics are only presented when the model has successfully converged. | Intent-to-Treat Population | Posted | Number | Percentage of participants | Day 1 |
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| Secondary | Number of Participants With Instructions (0, 1 or 2 Times) From the HCP Which Are Needed to Demonstrate Correct Inhaler Use | In each sub-study, if the participant made error while demonstrating the use of the DPI after reading the PIL, the HCP demonstrated the correct usage instructions to the participant. The participant was then asked to demonstrate the DPI again. Any errors made were recorded by the HCP, and the same process was repeated one more time. In total, the HCP instructed the participants on the use of the DPI up to two times after which there were no assessment scheduled. Number of participants with instructions (0, 1 or 2) needed to demonstrate correct DPI use by the participants were reported. | Intent-to-Treat Population | Posted | Number | Participants | Day 1 |
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| Secondary | The Median Time to Demonstrate Correct Inhaler Use (T1+T2) | For each DPI being tested, the total time taken from when participant started reading the PIL until when correct use was demonstrated (that is the time required to read PIL, and two attempts for correct use of DPI following instructions provided by the HCP ) was recorded. A participant who did not demonstrate correct use at the end of the time period was censored. The median time to demonstrate correct DPI use (minutes) is taken from the Kaplan-Meier analysis. If more than 50% of the data is censored therefore the median is not applicable. | Intent-to-Treat Population. | Posted | Median | Full Range | Minutes | Day 1 |
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| Secondary | Time Taken to Read the PIL and Demonstrate Correct Inhaler Use (T1) | For each DPI being tested, the time taken from when participant started reading the PIL until when correct use was demonstrated with no need of instructions by HCP was reported. A participant who did not demonstrate correct use at the end of the time period was censored. The median time to demonstrate correct DPI use (minutes) is taken from the Kaplan-Meier analysis. If more than 50% of the data is censored therefore the median is not applicable. | Intent-to-Treat Population.. | Posted | Median | Full Range | Minutes | Day 1 |
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| Secondary | Time Taken to be Given Instruction by the HCP (up to 2 Times) on Use of the Inhaler and to Demonstrate Correct Inhaler Use (T2) | The time in minutes from when the HCP started to instruct participant for the correct use of DPI until correct use was demonstrated including maximum of two attempts only, was recorded. A participant who did not demonstrate correct use at the end of the time period was censored. Participants who demonstrated correct use after reading the PIL (T1) were included with a time of 0 for T2. The median time to demonstrate correct DPI use (minutes) is taken from the Kaplan-Meier analysis. If more than 50% of the data is censored then the median is not applicable. Participants who demonstrated correct use after reading the PIL are included with T2=0. | Intent-to-Treat Population. | Posted | Median | Full Range | Minutes | Day 1 |
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| Secondary | Number of Participants With Treatment Preference Based on Responses to the Preference Questionnaire, Which Considered the Number of Steps Required to Take the COPD Medication | Participants demonstrated the use of ELLIPTA, and depending on the substudy DISKUS plus HandiHaler or Turbuhaler plus Handihaler. At the end of Visit 1, participants completed specific versions of the inhaler PQ (PQ1, PQ2, PQ3 or PQ4) according to the questionnaire they were randomized to. Participants assessed the inhaler preference based on the number of steps needed to take the COPD medication. Participants checked the response from the choice of ELLIPTA, DISKUS + HandiHaler (sub-study 1), Turbuhaler + Handihaler (sub-study 2) and No Preference. Number of participants with treatment preference based on responses to the preference questionnaire were reported. | Intent-to-Treat Population | Posted | Number | Participants | Day 1 |
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| Secondary | Number of Participants With Treatment Preference Based on Responses to the Preference Questionnaire, Which Considered Overall Treatment Preference | Participants demonstrated the use of ELLIPTA, and depending on the substudy DISKUS plus HandiHaler or Turbuhaler plus Handihaler. At the end of Visit 1, participants completed specific versions of the inhaler PQ (PQ1, PQ2, PQ3 or PQ4) according to the questionnaire they were randomized to. Participants assessed the inhaler preference based on overall treatment preference. Participants checked the response from the choice of ELLIPTA, DISKUS + HandiHaler (sub-study 1), Turbuhaler + Handihaler (sub-study 2) and No Preference. Number of participants with treatment preference based on responses to the preference questionnaire were reported. | Intent-to-Treat Population | Posted | Number | Participants | Day 1 |
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Day 1
Intent-to-Treat Population was used to collect Adverse Events. Since all participants received placebo as treatment, data has been clubbed for all the arms. No Serious Adverse Events or deaths were reported during this study.
Not provided
| 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 + HandiHaler | Participants received placebo via one of the following devices: ELLIPTA® DPI or DISKUS® DPI in combination with HANDIHALER® DPI based on the following four sequences. The sequences also include the preference questionnaire version: A (ELLIPTA in period 1 and DISKUS + HandiHaler in period 2,followed by PQ1), B (DISKUS + HandiHaler in period 1 and ELLIPTA in period 2,followed by PQ2), C (ELLIPTA in period 1 and DISKUS + HandiHaler in period 2, followed by PQ2), D (DISKUS + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ1) respectively. There was no active treatment and participants continued to take their own prescribed COPD medication for the duration of the study. | 0 | 80 | 0 | 80 | 1 | 80 |
| EG001 | Sub Study 2: ELLIPTA vs Turbuhaler + HandiHaler | Participants received placebo via one of the following devices: ELLIPTA DPI or TURBUHALER® DPI in combination with HANDIHALER DPI based on the following four sequences. The sequences also include the preference questionnaire version: : E (ELLIPTA in period 1 and Turbuhaler + HandiHaler in period 2, followed by PQ3), F (Turbuhaler + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ4), G (ELLIPTA in period 1 and Turbuhaler + HandiHaler in period 2, followed by PQ4), H (Turbuhaler + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ3) respectively. There was no active treatment and participants continued to take their own prescribed COPD medication for the duration of the study. | 0 | 79 | 0 | 79 | 0 | 79 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Laceration | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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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 | GSKClinicalSupportHD@gsk.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Sep 15, 2016 | Apr 18, 2018 | Prot_001.pdf |
| 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 |
Not provided
Not provided
| Male |
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| Asian - Central/South Asian Heritage |
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| Asian - South East Asian Heritage |
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| White - Arabic/North African Heritage |
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| White - White/Caucasian/European Heritage |
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| Sub study 2:Turbuhaler + HandiHaler vs ELLIPTA | stratified exact logistic model | <0.001 | Odds Ratio (OR) | 27.744 | 2-Sided | 95 | 10.512 | The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA. | Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect. | Superiority |
Participants were randomized to use placebo via ELLIPTA in period 1 or 2. |
| OG003 | Sub-study 2 : Turbuhaler + HandiHaler | Participants were randomized to use placebo via TURBUHALER + HANDIHALER in period 1 or 2. |
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| Sub-study 2 : ELLIPTA |
Participants were randomized to use placebo via ELLIPTA in period 1 or 2. |
| OG003 | Sub-study 2 : Turbuhaler + HandiHaler | Participants were randomized to use placebo via TURBUHALER + HANDIHALER in period 1 or 2. |
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| OG003 |
| Sub-study 2 : Turbuhaler + HandiHaler |
Participants were randomized to use placebo via TURBUHALER + HANDIHALER in period 1 or 2. |
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Participants were randomized to use placebo via TURBUHALER + HANDIHALER in period 1 or 2.
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Participants were randomized to use placebo via TURBUHALER + HANDIHALER in period 1 or 2. |
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| OG003 | Sub-study 2 : Turbuhaler + HandiHaler | Participants were randomized to use placebo via TURBUHALER + HANDIHALER in period 1 or 2. |
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| Sub-study 2 : Turbuhaler + HandiHaler |
Participants were randomized to use placebo via TURBUHALER + HANDIHALER in period 1 or 2. |
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Participants were randomized to use placebo via TURBUHALER + HANDIHALER in period 1 or 2. |
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| OG003 | Sub-study 2 : Turbuhaler + HandiHaler | Participants were randomized to use placebo via TURBUHALER + HANDIHALER in period 1 or 2. |
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| OG001 | Sub Study 2: ELLIPTA vs Turbuhaler + HandiHaler | Participants received placebo via one of the following devices: ELLIPTA DPI or TURBUHALER® DPI in combination with HANDIHALER DPI based on the following four sequences. The sequences also include the preference questionnaire version: : E (ELLIPTA in period 1 and Turbuhaler + HandiHaler in period 2, followed by PQ3), F (Turbuhaler + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ4), G (ELLIPTA in period 1 and Turbuhaler + HandiHaler in period 2, followed by PQ4), H (Turbuhaler + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ3) respectively. There was no active treatment and participants continued to take their own prescribed COPD medication for the duration of the study. |
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| OG001 |
| Sub Study 2: ELLIPTA vs Turbuhaler + HandiHaler |
Participants received placebo via one of the following devices: ELLIPTA DPI or TURBUHALER® DPI in combination with HANDIHALER DPI based on the following four sequences. The sequences also include the preference questionnaire version: : E (ELLIPTA in period 1 and Turbuhaler + HandiHaler in period 2, followed by PQ3), F (Turbuhaler + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ4), G (ELLIPTA in period 1 and Turbuhaler + HandiHaler in period 2, followed by PQ4), H (Turbuhaler + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ3) respectively. There was no active treatment and participants continued to take their own prescribed COPD medication for the duration of the study. |
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