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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-002266-45 | EudraCT Number |
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GlaxoSmithKline (GSK) in collaboration with Propeller Health has developed a sensor, which can clip on to the ELLIPTA® dry powder inhaler (DPI) and monitor the time and date that the ELLIPTA DPI cover is fully opened and closed. Additionally, a sensor will be attached to the rescue medication metered dose inhaler (MDI). The data from both sensors will be fed back to the subject via an application (app) on smart phone and will be reviewed by the subject's health care professional (HCP) via an online dashboard. The sensors, app, dashboard and systems to provide data comprise the CIS. This study will be the first to evaluate the effect of CIS on adherence to maintenance therapy in subjects with uncontrolled asthma. This is an open-label, randomized, parallel group study in asthmatic subjects currently on a fixed dose inhaled corticosteroid (ICS)/long-acting beta 2 agonist (LABA) maintenance therapy. Eligible subjects will receive RELVAR®/BREO® maintenance therapy via ELLIPTA DPI and salbutamol rescue medication via MDI with sensors attached to both inhalers during the run-in period, which may last for up to 3 months. Eligible subjects will then be randomized into five treatment arms depending on whether the data, from RELVAR/BREO ELLIPTA or RELVAR/BREO ELLIPTA and salbutamol MDI, is fed back to the subject or subject and HCP, or not at all. The treatment period for the study is approximately 6 months and there will be a follow-up period one week post last visit. The total duration of a subject in the study will be approximately 9 months. RELVAR, BREO and ELLIPTA are registered trademarks of GlaxoSmithKline group of companies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Data on Maintenance use supplied to Subject and HCP | Experimental | Eligible subjects will receive RELVAR/BREO maintenance therapy via ELLIPTA DPI and salbutamol rescue medication via MDI with sensors attached to both inhalers. Information from sensor attached to RELVAR/BREO ELLIPTA will be fed back to the subject via an app on smart phone and to the subject's HCP via an online dashboard. |
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| Data on Maintenance use supplied to Subject | Experimental | Eligible subjects will receive RELVAR/BREO maintenance therapy via ELLIPTA DPI and salbutamol rescue medication via MDI with sensors attached to both inhalers. Information from sensor attached to RELVAR/BREO ELLIPTA will be fed back to the subject via an app on smart phone. |
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| Data on Maintenance and Rescue use supplied to Subject and HCP | Experimental | Eligible subjects will receive RELVAR/BREO maintenance therapy via ELLIPTA DPI and salbutamol rescue medication via MDI with sensors attached to both inhalers. Information from sensors attached to RELVAR/BREO ELLIPTA and salbutamol MDI will be fed back to both subject and HCP. The data will be fed back to the subject through an app and to HCP through an online dashboard. |
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| Data on Maintenance and Rescue use supplied to Subject |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RELVAR/BREO | Drug | RELVAR/BREO will be available at doses of 100/25 micrograms (µg) and 200/25 µg to be administered via ELLIPTA DPI. Subjects will be administered one inhalation of RELVAR/BREO once daily. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 4 and Month 6 as Determined by the Maintenance Sensor for Arms; ("Cohort 1: Data on Maintenance Use Supplied to Participant and HCP" and"Cohort 5: no Data Supplied to Participant or HCP") | Daily adherence is defined as the participant taking one dose of Relvar/Breo ELLIPTA, within a 24-hour period, starting at 12.00 anti-meridiem (a.m.) each day of the treatment period. The percentage of ELLIPTA doses taken were determined by the clip-on sensor attached to ELLIPTA, which records the time and date when the ELLIPTA cover was opened and closed. Analysis was carried out by Analysis of Covariance (ANCOVA) model. Least Square mean percentage of ELLIPTA doses taken (daily adherence) between Months 4 and 6 was determined by the maintenance sensor daily adherence over the last three months of the study period (between months 4 to 6). The daily adherence to ELLIPTA maintenance therapy when both the participant and the HCP were supplied with data from the maintenance sensor (Cohort 1) versus no data supplied to the participant or HCP (Cohort 5) is summarized. | Month 4 to Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 4 and Month 6 as Determined by the Maintenance Sensor | Daily adherence is defined as the participant taking one dose of Relvar/Breo ELLIPTA, within a 24-hour period, starting at 12.00 a.m. each day of the treatment period. The percentage of ELLIPTA doses taken were determined by the clip-on sensor attached to ELLIPTA, which records the time and date when the ELLIPTA cover was opened and closed. Least Square mean percentage of ELLIPTA doses taken (daily adherence) between Months 4 and 6 was determined by the maintenance sensor daily adherence over the last three months of the study period (between months 4 to 6). The effect on daily adherence to maintenance therapy when maintenance data was only supplied to participants (Cohort 2), rescue and maintenance data were supplied to participant and HCP (Cohort 3), and rescue and maintenance data only supplied to participant (Cohort 4) versus no data supplied to the participant or HCP (Cohort 5) is summarized. |
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Inclusion Criteria:
Inclusion criteria for randomization:
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 | Aventura | Florida | 33180 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33334936 | Derived | Moore A, Preece A, Sharma R, Heaney LG, Costello RW, Wise RA, Ludwig-Sengpiel A, Mosnaim G, Rees J, Tomlinson R, Tal-Singer R, Stempel DA, Barnes N. A randomised controlled trial of the effect of a connected inhaler system on medication adherence in uncontrolled asthmatic patients. Eur Respir J. 2021 Jun 4;57(6):2003103. doi: 10.1183/13993003.03103-2020. Print 2021 Jun. |
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IPD for this study is available via the Clinical Study Data Request site.
IPD is available via the Clinical Study Data Request site (copy the URL below to your browser)
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
A total of 528 participants were screened and 437 participants were enrolled and randomized in this study.
This was an open-label, randomized, multi-center, parallel group study to evaluate the effect of the connected inhaler system (CIS) on adherence to Relvar/Breo ELLIPTA therapy, in asthmatic participants (Par) with poor control.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: Data on Maintenance Use Supplied to Par and HCP | Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 microgram (mcg) or 200/25 mcg per actuation administered via ELLIPTA dry powder inhaler (DPI), one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via metered dose inhaler (MDI), as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensor attached to Relvar/Breo ELLIPTA was fed back to the participant via an application on smart phone and to the participant's healthcare professional (HCP) via an online dashboard. |
| 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 |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 10, 2018 | Dec 27, 2019 |
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Eligible subjects will receive RELVAR/BREO maintenance therapy via ELLIPTA DPI and salbutamol rescue medication via MDI. Clip-on sensors will be attached to both inhalers which will provide data on maintenance therapy and rescue medication use to the subjects and their HCP. Subjects will be randomized into five treatment arms in a ratio of 1:1:1:1:1 depending on whether the data, from RELVAR/BREO ELLIPTA or RELVAR/BREO ELLIPTA and salbutamol MDI, is fed back to the subject or subject and HCP, or not at all.
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| Experimental |
Eligible subjects will receive RELVAR/BREO maintenance therapy via ELLIPTA DPI and salbutamol rescue medication via MDI with sensors attached to both inhalers. Information from sensors attached to RELVAR/BREO ELLIPTA and salbutamol MDI will be fed back to subject through an app. |
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| No data supplied to Subject or HCP | Active Comparator | Eligible subjects will receive RELVAR/BREO maintenance therapy via ELLIPTA DPI and salbutamol rescue medication via MDI with sensors attached to both inhalers. Subjects will be provided with a home hub through which their data will be uploaded during the study but the subjects and their HCP will not be able to view the data. |
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| Salbutamol | Drug | Salbutamol will be available at a dose of 100 µg to be administered via MDI. Subjects will be administered salbutamol as and when required. |
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| Smart phone app | Device | Subjects will be required to download an app associated with sensor on their smartphone. The sensors attached to the inhalers will be connected to the smartphone via Bluetooth. |
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| HCP Dashboard | Device | The information from sensors will be reviewed by the HCP via an online dashboard. |
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| Sensors | Device | Clip-on sensors will be fitted to electronically record the actuation data. |
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| Month 4 to Month 6 |
| Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 1 and Month 3 as Determined by the Maintenance Sensor | Daily adherence is defined as the participant taking one dose of Relvar/Breo ELLIPTA, within a 24-hour period, starting at 12.00 a.m. each day of the treatment period. The percentage of ELLIPTA doses taken were determined by the clip-on sensor attached to ELLIPTA, which records the time and date when the ELLIPTA cover was opened and closed. Least Square mean percentage of ELLIPTA doses taken (daily adherence) between Months 1 and 3 was determined by the maintenance sensor daily adherence. The effect on daily adherence to maintenance therapy when maintenance data was supplied to both the participant and the HCP (Cohort 1), maintenance data was only supplied to participants (Cohort 2), rescue and maintenance data were supplied to participant and HCP (Cohort 3), and rescue and maintenance data only supplied to participant (Cohort 4) versus no data supplied to the participant or HCP (Cohort 5) is summarized. | Month 1 to Month 3 |
| Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 1 and Month 6 as Determined by the Maintenance Sensor | Daily adherence is defined as the participant taking one dose of Relvar/Breo ELLIPTA, within a 24-hour period, starting at 12.00 a.m. each day of the treatment period. The percentage of ELLIPTA doses taken were determined by the clip-on sensor attached to ELLIPTA, which records the time and date when the ELLIPTA cover was opened and closed. Least Square mean percentage of ELLIPTA doses taken (daily adherence) between Months 1 and 6 was determined by the maintenance sensor daily adherence. The effect on daily adherence to maintenance therapy when maintenance data was supplied to both the participant and the HCP (Cohort 1), maintenance data was only supplied to participants (Cohort 2), rescue and maintenance data were supplied to participant and HCP (Cohort 3), and rescue and maintenance data only supplied to participant (Cohort 4) versus no data supplied to the participant or HCP (Cohort 5) is summarized. | Month 1 to Month 6 |
| Percentage of Rescue Free Days Between Month 4 and Month 6 as Determined by the Rescue Medication Sensor | Data for rescue medication use was collected by the clip-on sensor for salbutamol MDI which records time and date when the MDI was actuated. Percentage of rescue free days were determined by the rescue sensor records of date, time and number of inhaler actuations. Least Square mean percentage of rescue free days between Months 4 and 6 when maintenance data was supplied to both the participant and the HCP (Cohort 1); maintenance data was only supplied to participants (Cohort 2); rescue and maintenance data were supplied to participant and HCP (Cohort 3) and rescue and maintenance data only supplied to participant (Cohort 4) versus no data supplied to the participant or HCP (Cohort 5) is summarized. | Month 4 to Month 6 |
| Number of Doses of Rescue Medication Use Between Month 4 and Month 6 as Determined by the Rescue Medication Sensor | Data for rescue medication use was collected by the clip-on sensor for salbutamol MDI which records time and date when the MDI was actuated. Total rescue use was determined by the rescue sensor records of date, time and number of inhaler actuations. The mean number of doses of rescue medicines between Months 4 and 6 when maintenance data was supplied to both the participant and the HCP (Cohort 1); maintenance data was only supplied to participants (Cohort 2); rescue and maintenance data were supplied to participant and HCP (Cohort 3) and rescue and maintenance data only supplied to participant (Cohort 4) versus no data supplied to the participant or HCP (Cohort 5) is summarized. | Month 4 to Month 6 |
| Change From Baseline in Asthma Control Test (ACT) Total Score | The ACT is a validated self-completed questionnaire utilizing 5 questions to assess asthma control on a 5-point categorical scale ranging from 1 (not controlled at all) to 5 (completely controlled). Total score is calculated as the sum of the scores from the 5 questions and can range from 5 to 25, with higher scores indicating better control. An ACT total score of 5 to 19 suggests that the participant's asthma is unlikely to be well controlled, whilst a score of 20 to 25 suggests that the participant's asthma is likely to be well controlled. Baseline value was the latest assessment prior to randomization (Day 1, pre-dose). Change from Baseline was calculated as post-dose visit value minus the Baseline value. | Baseline and Month 6 |
| Percentage of Participants Attaining Asthma Control (Percentage of Participants With an ACT Total Score >=20) at Month 6 | Percentage of participants attaining asthma control was defined as participants with an ACT total score >=20 at Month 6. The ACT is a validated self-completed questionnaire utilizing 5 questions to assess asthma control on a 5-point categorical scale ranging from 1 (not controlled at all) to 5 (completely controlled). Total score is calculated as the sum of the scores from the 5 questions and can range from 5 to 25, with higher scores indicating better control. An ACT total score of 5 to 19 suggests that the participant's asthma is unlikely to be well controlled, whilst a score of 20 to 25 suggests that the participant's asthma is likely to be well controlled. Percentage of participants who attained asthma control at Month 6 is presented. | Month 6 |
| Percentage of Participants With an Increase From Baseline >=3 in ACT Total Score at Month 6 | The ACT is a validated self-completed questionnaire utilizing 5 questions to assess asthma control on a 5-point categorical scale ranging from 1 (not controlled at all) to 5 (completely controlled). Total score is calculated as the sum of the scores from the 5 questions and can range from 5 to 25, with higher scores indicating better control. An ACT total score of 5 to 19 suggests that the participant's asthma is unlikely to be well controlled, whilst a score of 20 to 25 suggests that the participant's asthma is likely to be well controlled. Baseline value was the latest assessment prior to randomization (Day 1, pre-dose). Percentage of participants with an increase from Baseline >=3 in ACT total score at Month 6 is presented. | Baseline and Month 6 |
| Percentage of Participants Who Have Either an ACT Total Score of >=20 and/or an Increase From Baseline >=3 in ACT Total Score at Month 6 | The ACT is a validated self-completed questionnaire utilizing 5 questions to assess asthma control on a 5-point categorical scale ranging from 1 (not controlled at all) to 5 (completely controlled). Total score is calculated as the sum of the scores from the 5 questions and can range from 5 to 25, with higher scores indicating better control. Baseline value was the latest assessment prior to randomization (Day 1, pre-dose). Percentage of participants who had either an ACT total score of >=20 and/or an increase from Baseline >=3 in ACT total score at Month 6 is presented. | Baseline and Month 6 |
| Miami |
| Florida |
| 33173 |
| United States |
| GSK Investigational Site | Flossmoor | Illinois | 60422 | United States |
| GSK Investigational Site | Glenview | Illinois | 60026 | United States |
| GSK Investigational Site | Hazelwood | Missouri | 63042 | United States |
| GSK Investigational Site | Charlotte | North Carolina | 28277 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73120 | United States |
| GSK Investigational Site | Medford | Oregon | 97504 | United States |
| GSK Investigational Site | San Antonio | Texas | 78229 | United States |
| GSK Investigational Site | Richmond | Virginia | 23230 | United States |
| GSK Investigational Site | Greenfield | Wisconsin | 53228 | United States |
| GSK Investigational Site | Kelowna | British Columbia | V1W 1V3 | Canada |
| GSK Investigational Site | Vancouver | British Columbia | V5Z 1M9 | Canada |
| GSK Investigational Site | Ajax | Ontario | L1S 2J5 | Canada |
| GSK Investigational Site | Burlington | Ontario | L7N 3V2 | Canada |
| GSK Investigational Site | London | Ontario | N5W 6A2 | Canada |
| GSK Investigational Site | Sarnia | Ontario | N7T 4X3 | Canada |
| GSK Investigational Site | Toronto | Ontario | M5T 3A9 | Canada |
| GSK Investigational Site | Toronto | Ontario | M9V 4B4 | Canada |
| GSK Investigational Site | Toronto | Ontario | M9W 4L6 | Canada |
| GSK Investigational Site | Windsor | Ontario | N8X2G1 | Canada |
| GSK Investigational Site | Montreal | Quebec | H4J 1C5 | Canada |
| GSK Investigational Site | Québec | Quebec | G1N 4V3 | Canada |
| GSK Investigational Site | Québec | Quebec | G1W 4R4 | Canada |
| GSK Investigational Site | Québec | Quebec | G3K 2P8 | Canada |
| GSK Investigational Site | Sherbrooke | Quebec | J1L 0H8 | Canada |
| GSK Investigational Site | Victoriaville | Quebec | G6P 6P6 | Canada |
| GSK Investigational Site | Rüdersdorf | Brandenburg | 15562 | Germany |
| GSK Investigational Site | Darmstadt | Hesse | 64283 | Germany |
| GSK Investigational Site | Warendorf | North Rhine-Westphalia | 48231 | Germany |
| GSK Investigational Site | Leipzig | Saxony | 04103 | Germany |
| GSK Investigational Site | Leipzig | Saxony | 04357 | Germany |
| GSK Investigational Site | Lübeck | Schleswig-Holstein | 23552 | Germany |
| GSK Investigational Site | Berlin | 10119 | Germany |
| GSK Investigational Site | Berlin | 12203 | Germany |
| GSK Investigational Site | Berlin | 13156 | Germany |
| GSK Investigational Site | Berlin | 14059 | Germany |
| GSK Investigational Site | Naples | Campania | 80131 | Italy |
| GSK Investigational Site | Salerno | Campania | 84131 | Italy |
| GSK Investigational Site | Pordenone | Friuli Venezia Giulia | 33170 | Italy |
| GSK Investigational Site | Palermo | Sicily | 90146 | Italy |
| GSK Investigational Site | Pisa | Tuscany | 56124 | Italy |
| GSK Investigational Site | Breda | 4818 CK | Netherlands |
| GSK Investigational Site | Groningen | 9728 NT | Netherlands |
| GSK Investigational Site | Hengelo | 7555 DL | Netherlands |
| GSK Investigational Site | Hoorn | 1624 NP | Netherlands |
| GSK Investigational Site | The Hague | 2526 HW | Netherlands |
| GSK Investigational Site | Zutphen | 7207 AE | Netherlands |
| GSK Investigational Site | A Coruña | 15011 | Spain |
| GSK Investigational Site | Balenyà (Barcelona) | 08550 | Spain |
| GSK Investigational Site | Barcelona | 08028 | Spain |
| GSK Investigational Site | Barcelona | 08036 | Spain |
| GSK Investigational Site | La Roca Del Valles (Barcelona) | 08430 | Spain |
| GSK Investigational Site | Loja/ Granada | 18300 | Spain |
| GSK Investigational Site | Madrid | 28034 | Spain |
| GSK Investigational Site | Madrid | 28044 | Spain |
| GSK Investigational Site | Peralada( Girona) | 17491 | Spain |
| GSK Investigational Site | Aylesbury | Buckinghamshire | HP21 8AL | United Kingdom |
| GSK Investigational Site | Wigan | Lancashire | WN1 2NN | United Kingdom |
| GSK Investigational Site | Wellingborough | Northamptonshire | NN8 4RW | United Kingdom |
| GSK Investigational Site | Addlestone | Surrey | KT15 2BH | United Kingdom |
| GSK Investigational Site | Rotherham | Yorkshire | S65 1DA | United Kingdom |
| GSK Investigational Site | Bristol | BS37 4AX | United Kingdom |
| GSK Investigational Site | Chelmsford | CM1 7ET | United Kingdom |
| GSK Investigational Site | Chertsey, Surrey | KT16 0PZ | United Kingdom |
| GSK Investigational Site | Harrogate | HG2 7SX | United Kingdom |
| FG001 | Cohort 2: Data on Maintenance Use Supplied to Par | Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensor attached to Relvar/Breo ELLIPTA was fed back to the participant only via an application on smart phone. |
| FG002 | Cohort 3: Data on Maintenance and Rescue Use to Par and HCP | Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensors attached to Relvar/Breo ELLIPTA and salbutamol MDI was fed back to the participant via an application on smart phone and to HCP via an online dashboard. |
| FG003 | Cohort 4: Data on Maintenance and Rescue Use Supplied to Par | Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensors attached to Relvar/Breo ELLIPTA and salbutamol MDI was fed back to the participant via an application on smart phone. |
| FG004 | Cohort 5: No Data Supplied to Par or HCP | Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Participants were provided with a home hub through which their data was uploaded during the study but the participants and their HCP were not able to view the data. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: Data on Maintenance Use Supplied to Par and HCP | Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 microgram (mcg) or 200/25 mcg per actuation administered via ELLIPTA dry powder inhaler (DPI), one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via metered dose inhaler (MDI), as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensor attached to Relvar/Breo ELLIPTA was fed back to the participant via an application on smart phone and to the participant's healthcare professional (HCP) via an online dashboard. |
| BG001 | Cohort 2: Data on Maintenance Use Supplied to Par | Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensor attached to Relvar/Breo ELLIPTA was fed back to the participant only via an application on smart phone. |
| BG002 | Cohort 3: Data on Maintenance and Rescue Use to Par and HCP | Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensors attached to Relvar/Breo ELLIPTA and salbutamol MDI was fed back to the participant via an application on smart phone and to HCP via an online dashboard. |
| BG003 | Cohort 4: Data on Maintenance and Rescue Use Supplied to Par | Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensors attached to Relvar/Breo ELLIPTA and salbutamol MDI was fed back to the participant via an application on smart phone. |
| BG004 | Cohort 5: No Data Supplied to Par or HCP | Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Participants were provided with a home hub through which their data was uploaded during the study but the participants and their HCP were not able to view the data. |
| BG005 | 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 | ||||||||||
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 4 and Month 6 as Determined by the Maintenance Sensor for Arms; ("Cohort 1: Data on Maintenance Use Supplied to Participant and HCP" and"Cohort 5: no Data Supplied to Participant or HCP") | Daily adherence is defined as the participant taking one dose of Relvar/Breo ELLIPTA, within a 24-hour period, starting at 12.00 anti-meridiem (a.m.) each day of the treatment period. The percentage of ELLIPTA doses taken were determined by the clip-on sensor attached to ELLIPTA, which records the time and date when the ELLIPTA cover was opened and closed. Analysis was carried out by Analysis of Covariance (ANCOVA) model. Least Square mean percentage of ELLIPTA doses taken (daily adherence) between Months 4 and 6 was determined by the maintenance sensor daily adherence over the last three months of the study period (between months 4 to 6). The daily adherence to ELLIPTA maintenance therapy when both the participant and the HCP were supplied with data from the maintenance sensor (Cohort 1) versus no data supplied to the participant or HCP (Cohort 5) is summarized. | Intent-to-Treat (ITT) Population comprised of all randomized participants, excluding those who were randomized in error. Only those participants with adherence data observed/imputed at the specified time points were analyzed. | Posted | Least Squares Mean | Standard Error | Percentage of ELLIPTA doses | Month 4 to Month 6 |
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| Secondary | Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 4 and Month 6 as Determined by the Maintenance Sensor | Daily adherence is defined as the participant taking one dose of Relvar/Breo ELLIPTA, within a 24-hour period, starting at 12.00 a.m. each day of the treatment period. The percentage of ELLIPTA doses taken were determined by the clip-on sensor attached to ELLIPTA, which records the time and date when the ELLIPTA cover was opened and closed. Least Square mean percentage of ELLIPTA doses taken (daily adherence) between Months 4 and 6 was determined by the maintenance sensor daily adherence over the last three months of the study period (between months 4 to 6). The effect on daily adherence to maintenance therapy when maintenance data was only supplied to participants (Cohort 2), rescue and maintenance data were supplied to participant and HCP (Cohort 3), and rescue and maintenance data only supplied to participant (Cohort 4) versus no data supplied to the participant or HCP (Cohort 5) is summarized. | ITT Population. Only those participants with adherence data observed/imputed at the specified time points were analyzed. | Posted | Least Squares Mean | Standard Error | Percentage of ELLIPTA doses | Month 4 to Month 6 |
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| Secondary | Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 1 and Month 3 as Determined by the Maintenance Sensor | Daily adherence is defined as the participant taking one dose of Relvar/Breo ELLIPTA, within a 24-hour period, starting at 12.00 a.m. each day of the treatment period. The percentage of ELLIPTA doses taken were determined by the clip-on sensor attached to ELLIPTA, which records the time and date when the ELLIPTA cover was opened and closed. Least Square mean percentage of ELLIPTA doses taken (daily adherence) between Months 1 and 3 was determined by the maintenance sensor daily adherence. The effect on daily adherence to maintenance therapy when maintenance data was supplied to both the participant and the HCP (Cohort 1), maintenance data was only supplied to participants (Cohort 2), rescue and maintenance data were supplied to participant and HCP (Cohort 3), and rescue and maintenance data only supplied to participant (Cohort 4) versus no data supplied to the participant or HCP (Cohort 5) is summarized. | ITT Population. Only those participants with adherence data observed/imputed at the specified time points were analyzed. | Posted | Least Squares Mean | Standard Error | Percentage of ELLIPTA doses | Month 1 to Month 3 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 1 and Month 6 as Determined by the Maintenance Sensor | Daily adherence is defined as the participant taking one dose of Relvar/Breo ELLIPTA, within a 24-hour period, starting at 12.00 a.m. each day of the treatment period. The percentage of ELLIPTA doses taken were determined by the clip-on sensor attached to ELLIPTA, which records the time and date when the ELLIPTA cover was opened and closed. Least Square mean percentage of ELLIPTA doses taken (daily adherence) between Months 1 and 6 was determined by the maintenance sensor daily adherence. The effect on daily adherence to maintenance therapy when maintenance data was supplied to both the participant and the HCP (Cohort 1), maintenance data was only supplied to participants (Cohort 2), rescue and maintenance data were supplied to participant and HCP (Cohort 3), and rescue and maintenance data only supplied to participant (Cohort 4) versus no data supplied to the participant or HCP (Cohort 5) is summarized. | ITT Population. Only those participants with adherence data observed/imputed at the specified time points were analyzed. | Posted | Least Squares Mean | Standard Error | Percentage of ELLIPTA doses | Month 1 to Month 6 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Rescue Free Days Between Month 4 and Month 6 as Determined by the Rescue Medication Sensor | Data for rescue medication use was collected by the clip-on sensor for salbutamol MDI which records time and date when the MDI was actuated. Percentage of rescue free days were determined by the rescue sensor records of date, time and number of inhaler actuations. Least Square mean percentage of rescue free days between Months 4 and 6 when maintenance data was supplied to both the participant and the HCP (Cohort 1); maintenance data was only supplied to participants (Cohort 2); rescue and maintenance data were supplied to participant and HCP (Cohort 3) and rescue and maintenance data only supplied to participant (Cohort 4) versus no data supplied to the participant or HCP (Cohort 5) is summarized. | ITT Population. Only those participants with rescue data observed/imputed at the specified time points were analyzed. | Posted | Least Squares Mean | Standard Error | Percentage of rescue free days | Month 4 to Month 6 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Doses of Rescue Medication Use Between Month 4 and Month 6 as Determined by the Rescue Medication Sensor | Data for rescue medication use was collected by the clip-on sensor for salbutamol MDI which records time and date when the MDI was actuated. Total rescue use was determined by the rescue sensor records of date, time and number of inhaler actuations. The mean number of doses of rescue medicines between Months 4 and 6 when maintenance data was supplied to both the participant and the HCP (Cohort 1); maintenance data was only supplied to participants (Cohort 2); rescue and maintenance data were supplied to participant and HCP (Cohort 3) and rescue and maintenance data only supplied to participant (Cohort 4) versus no data supplied to the participant or HCP (Cohort 5) is summarized. | ITT Population. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | Doses of rescue medication | Month 4 to Month 6 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Asthma Control Test (ACT) Total Score | The ACT is a validated self-completed questionnaire utilizing 5 questions to assess asthma control on a 5-point categorical scale ranging from 1 (not controlled at all) to 5 (completely controlled). Total score is calculated as the sum of the scores from the 5 questions and can range from 5 to 25, with higher scores indicating better control. An ACT total score of 5 to 19 suggests that the participant's asthma is unlikely to be well controlled, whilst a score of 20 to 25 suggests that the participant's asthma is likely to be well controlled. Baseline value was the latest assessment prior to randomization (Day 1, pre-dose). Change from Baseline was calculated as post-dose visit value minus the Baseline value. | ITT Population. Only those participants with data available at the specified data points were analyzed. | Posted | Least Squares Mean | Standard Error | Scores on a Scale | Baseline and Month 6 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Attaining Asthma Control (Percentage of Participants With an ACT Total Score >=20) at Month 6 | Percentage of participants attaining asthma control was defined as participants with an ACT total score >=20 at Month 6. The ACT is a validated self-completed questionnaire utilizing 5 questions to assess asthma control on a 5-point categorical scale ranging from 1 (not controlled at all) to 5 (completely controlled). Total score is calculated as the sum of the scores from the 5 questions and can range from 5 to 25, with higher scores indicating better control. An ACT total score of 5 to 19 suggests that the participant's asthma is unlikely to be well controlled, whilst a score of 20 to 25 suggests that the participant's asthma is likely to be well controlled. Percentage of participants who attained asthma control at Month 6 is presented. | ITT Population | Posted | Number | Percentage of participants | Month 6 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With an Increase From Baseline >=3 in ACT Total Score at Month 6 | The ACT is a validated self-completed questionnaire utilizing 5 questions to assess asthma control on a 5-point categorical scale ranging from 1 (not controlled at all) to 5 (completely controlled). Total score is calculated as the sum of the scores from the 5 questions and can range from 5 to 25, with higher scores indicating better control. An ACT total score of 5 to 19 suggests that the participant's asthma is unlikely to be well controlled, whilst a score of 20 to 25 suggests that the participant's asthma is likely to be well controlled. Baseline value was the latest assessment prior to randomization (Day 1, pre-dose). Percentage of participants with an increase from Baseline >=3 in ACT total score at Month 6 is presented. | ITT Population | Posted | Number | Percentage of participants | Baseline and Month 6 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Have Either an ACT Total Score of >=20 and/or an Increase From Baseline >=3 in ACT Total Score at Month 6 | The ACT is a validated self-completed questionnaire utilizing 5 questions to assess asthma control on a 5-point categorical scale ranging from 1 (not controlled at all) to 5 (completely controlled). Total score is calculated as the sum of the scores from the 5 questions and can range from 5 to 25, with higher scores indicating better control. Baseline value was the latest assessment prior to randomization (Day 1, pre-dose). Percentage of participants who had either an ACT total score of >=20 and/or an increase from Baseline >=3 in ACT total score at Month 6 is presented. | ITT Population | Posted | Number | Percentage of participants | Baseline and Month 6 |
|
Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to 6 months
SAEs and non-serious AEs were reported for the ITT Population which comprised of all randomized participants, excluding those who were randomized in error.
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 | Cohort 1: Data on Maintenance Use Supplied to Par and HCP | Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 microgram (mcg) or 200/25 mcg per actuation administered via ELLIPTA dry powder inhaler (DPI), one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via metered dose inhaler (MDI), as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensor attached to Relvar/Breo ELLIPTA was fed back to the participant via an application on smart phone and to the participant's healthcare professional (HCP) via an online dashboard. | 0 | 87 | 2 | 87 | 4 | 87 |
| EG001 | Cohort 2: Data on Maintenance Use Supplied to Par | Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensor attached to Relvar/Breo ELLIPTA was fed back to the participant only via an application on smart phone. | 0 | 88 | 1 | 88 | 1 | 88 |
| EG002 | Cohort 3: Data on Maintenance and Rescue Use to Par and HCP | Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensors attached to Relvar/Breo ELLIPTA and salbutamol MDI was fed back to the participant via an application on smart phone and to HCP via an online dashboard. | 0 | 88 | 2 | 88 | 1 | 88 |
| EG003 | Cohort 4: Data on Maintenance and Rescue Use Supplied to Par | Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensors attached to Relvar/Breo ELLIPTA and salbutamol MDI was fed back to the participant via an application on smart phone. | 0 | 88 | 1 | 88 | 1 | 88 |
| EG004 | Cohort 5: No Data Supplied to Par or HCP | Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Participants were provided with a home hub through which their data was uploaded during the study but the participants and their HCP were not able to view the data. | 0 | 86 | 4 | 86 | 2 | 86 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Obstructive pancreatitis | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Ovarian germ cell teratoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oral candidiasis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Oral fungal infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
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 |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 21, 2019 | Dec 27, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000420 | Albuterol |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
Not provided
Not provided
| Male |
|
| Asian-Central/South Asian Heritage |
|
| Asian-East Asian Heritage |
|
| Asian-South East (SE) Asian Heritage (AH) |
|
| Black or African American |
|
| Native Hawaiian or other Pacific Islander |
|
| White-Arabic/North African heritage |
|
| White-White/Caucasian/European Heritage (EH) |
|
| AI or AN and Black or African American |
|
| AI or AN and White- White/Caucasian/EH |
|
| Asian-SE AH and White- White/Caucasian/EH |
|
| OG001 | Cohort 3: Data on Maintenance and Rescue Use to Par and HCP | Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensors attached to Relvar/Breo ELLIPTA and salbutamol MDI was fed back to the participant via an application on smart phone and to HCP via an online dashboard. |
| OG002 | Cohort 4: Data on Maintenance and Rescue Use Supplied to Par | Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensors attached to Relvar/Breo ELLIPTA and salbutamol MDI was fed back to the participant via an application on smart phone. |
| OG003 | Cohort 5: No Data Supplied to Par or HCP | Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Participants were provided with a home hub through which their data was uploaded during the study but the participants and their HCP were not able to view the data. |
|
|
|
| OG001 | Cohort 2: Data on Maintenance Use Supplied to Par | Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensor attached to Relvar/Breo ELLIPTA was fed back to the participant only via an application on smart phone. |
| OG002 | Cohort 3: Data on Maintenance and Rescue Use to Par and HCP | Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensors attached to Relvar/Breo ELLIPTA and salbutamol MDI was fed back to the participant via an application on smart phone and to HCP via an online dashboard. |
| OG003 | Cohort 4: Data on Maintenance and Rescue Use Supplied to Par | Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensors attached to Relvar/Breo ELLIPTA and salbutamol MDI was fed back to the participant via an application on smart phone. |
| OG004 | Cohort 5: No Data Supplied to Par or HCP | Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Participants were provided with a home hub through which their data was uploaded during the study but the participants and their HCP were not able to view the data. |
|
|
|
| OG001 | Cohort 2: Data on Maintenance Use Supplied to Par | Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensor attached to Relvar/Breo ELLIPTA was fed back to the participant only via an application on smart phone. |
| OG002 | Cohort 3: Data on Maintenance and Rescue Use to Par and HCP | Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensors attached to Relvar/Breo ELLIPTA and salbutamol MDI was fed back to the participant via an application on smart phone and to HCP via an online dashboard. |
| OG003 | Cohort 4: Data on Maintenance and Rescue Use Supplied to Par | Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensors attached to Relvar/Breo ELLIPTA and salbutamol MDI was fed back to the participant via an application on smart phone. |
| OG004 | Cohort 5: No Data Supplied to Par or HCP | Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Participants were provided with a home hub through which their data was uploaded during the study but the participants and their HCP were not able to view the data. |
|
|
|
| OG001 | Cohort 2: Data on Maintenance Use Supplied to Par | Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensor attached to Relvar/Breo ELLIPTA was fed back to the participant only via an application on smart phone. |
| OG002 | Cohort 3: Data on Maintenance and Rescue Use to Par and HCP | Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensors attached to Relvar/Breo ELLIPTA and salbutamol MDI was fed back to the participant via an application on smart phone and to HCP via an online dashboard. |
| OG003 | Cohort 4: Data on Maintenance and Rescue Use Supplied to Par | Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensors attached to Relvar/Breo ELLIPTA and salbutamol MDI was fed back to the participant via an application on smart phone. |
| OG004 | Cohort 5: No Data Supplied to Par or HCP | Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Participants were provided with a home hub through which their data was uploaded during the study but the participants and their HCP were not able to view the data. |
|
|
|
| OG001 | Cohort 2: Data on Maintenance Use Supplied to Par | Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensor attached to Relvar/Breo ELLIPTA was fed back to the participant only via an application on smart phone. |
| OG002 | Cohort 3: Data on Maintenance and Rescue Use to Par and HCP | Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensors attached to Relvar/Breo ELLIPTA and salbutamol MDI was fed back to the participant via an application on smart phone and to HCP via an online dashboard. |
| OG003 | Cohort 4: Data on Maintenance and Rescue Use Supplied to Par | Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensors attached to Relvar/Breo ELLIPTA and salbutamol MDI was fed back to the participant via an application on smart phone. |
| OG004 | Cohort 5: No Data Supplied to Par or HCP | Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Participants were provided with a home hub through which their data was uploaded during the study but the participants and their HCP were not able to view the data. |
|
|
| OG001 | Cohort 2: Data on Maintenance Use Supplied to Par | Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensor attached to Relvar/Breo ELLIPTA was fed back to the participant only via an application on smart phone. |
| OG002 | Cohort 3: Data on Maintenance and Rescue Use to Par and HCP | Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensors attached to Relvar/Breo ELLIPTA and salbutamol MDI was fed back to the participant via an application on smart phone and to HCP via an online dashboard. |
| OG003 | Cohort 4: Data on Maintenance and Rescue Use Supplied to Par | Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensors attached to Relvar/Breo ELLIPTA and salbutamol MDI was fed back to the participant via an application on smart phone. |
| OG004 | Cohort 5: No Data Supplied to Par or HCP | Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Participants were provided with a home hub through which their data was uploaded during the study but the participants and their HCP were not able to view the data. |
|
|
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| OG001 | Cohort 2: Data on Maintenance Use Supplied to Par | Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensor attached to Relvar/Breo ELLIPTA was fed back to the participant only via an application on smart phone. |
| OG002 | Cohort 3: Data on Maintenance and Rescue Use to Par and HCP | Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensors attached to Relvar/Breo ELLIPTA and salbutamol MDI was fed back to the participant via an application on smart phone and to HCP via an online dashboard. |
| OG003 | Cohort 4: Data on Maintenance and Rescue Use Supplied to Par | Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensors attached to Relvar/Breo ELLIPTA and salbutamol MDI was fed back to the participant via an application on smart phone. |
| OG004 | Cohort 5: No Data Supplied to Par or HCP | Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Participants were provided with a home hub through which their data was uploaded during the study but the participants and their HCP were not able to view the data. |
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| OG001 |
| Cohort 2: Data on Maintenance Use Supplied to Par |
Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensor attached to Relvar/Breo ELLIPTA was fed back to the participant only via an application on smart phone. |
| OG002 | Cohort 3: Data on Maintenance and Rescue Use to Par and HCP | Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensors attached to Relvar/Breo ELLIPTA and salbutamol MDI was fed back to the participant via an application on smart phone and to HCP via an online dashboard. |
| OG003 | Cohort 4: Data on Maintenance and Rescue Use Supplied to Par | Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensors attached to Relvar/Breo ELLIPTA and salbutamol MDI was fed back to the participant via an application on smart phone. |
| OG004 | Cohort 5: No Data Supplied to Par or HCP | Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Participants were provided with a home hub through which their data was uploaded during the study but the participants and their HCP were not able to view the data. |
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Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensor attached to Relvar/Breo ELLIPTA was fed back to the participant only via an application on smart phone. |
| OG002 | Cohort 3: Data on Maintenance and Rescue Use to Par and HCP | Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensors attached to Relvar/Breo ELLIPTA and salbutamol MDI was fed back to the participant via an application on smart phone and to HCP via an online dashboard. |
| OG003 | Cohort 4: Data on Maintenance and Rescue Use Supplied to Par | Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Information from sensors attached to Relvar/Breo ELLIPTA and salbutamol MDI was fed back to the participant via an application on smart phone. |
| OG004 | Cohort 5: No Data Supplied to Par or HCP | Eligible participants received Relvar/Breo maintenance therapy at doses of 100/25 mcg or 200/25 mcg per actuation administered via ELLIPTA DPI, one inhalation once daily. Participants also received salbutamol rescue medication at dose of 100 mcg per actuation administered via MDI, as and when required. Sensors were attached to both the inhalers to electronically record actuation data. Participants were provided with a home hub through which their data was uploaded during the study but the participants and their HCP were not able to view the data. |
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