Trial Outcomes & Findings for A Clinical Study to Evaluate the Effect of the Connected Inhaler System (CIS) on Adherence to Maintenance Therapy in Poorly Controlled Asthmatic Subjects (NCT NCT03380429)
NCT ID: NCT03380429
Last Updated: 2021-04-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
437 participants
Primary outcome timeframe
Month 4 to Month 6
Results posted on
2021-04-12
Participant Flow
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.
A total of 528 participants were screened and 437 participants were enrolled and randomized in this study.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
87
|
88
|
88
|
88
|
86
|
|
Overall Study
COMPLETED
|
82
|
81
|
77
|
78
|
81
|
|
Overall Study
NOT COMPLETED
|
5
|
7
|
11
|
10
|
5
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
5
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
4
|
3
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
1
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
0
|
2
|
1
|
|
Overall Study
Adverse Event
|
1
|
1
|
1
|
2
|
0
|
Baseline Characteristics
A Clinical Study to Evaluate the Effect of the Connected Inhaler System (CIS) on Adherence to Maintenance Therapy in Poorly Controlled Asthmatic Subjects
Baseline characteristics by cohort
| Measure |
Cohort 1: Data on Maintenance Use Supplied to Par and HCP
n=87 Participants
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.
|
Cohort 2: Data on Maintenance Use Supplied to Par
n=88 Participants
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.
|
Cohort 3: Data on Maintenance and Rescue Use to Par and HCP
n=88 Participants
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.
|
Cohort 4: Data on Maintenance and Rescue Use Supplied to Par
n=88 Participants
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.
|
Cohort 5: No Data Supplied to Par or HCP
n=86 Participants
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.
|
Total
n=437 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
46.7 Years
STANDARD_DEVIATION 15.79 • n=5 Participants
|
47.0 Years
STANDARD_DEVIATION 14.70 • n=7 Participants
|
47.8 Years
STANDARD_DEVIATION 15.28 • n=5 Participants
|
47.8 Years
STANDARD_DEVIATION 13.23 • n=4 Participants
|
47.2 Years
STANDARD_DEVIATION 15.91 • n=21 Participants
|
47.3 Years
STANDARD_DEVIATION 14.95 • n=10 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
284 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
153 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
American Indian (AI) or Alaska native (AN)
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian-Central/South Asian Heritage
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian-East Asian Heritage
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian-South East (SE) Asian Heritage (AH)
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
10 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
34 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White-Arabic/North African heritage
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White-White/Caucasian/European Heritage (EH)
|
72 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
73 Participants
n=21 Participants
|
371 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
AI or AN and Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
AI or AN and White- White/Caucasian/EH
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian-SE AH and White- White/Caucasian/EH
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Month 4 to Month 6Population: 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.
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.
Outcome measures
| Measure |
Cohort 1: Data on Maintenance Use Supplied to Par and HCP
n=83 Participants
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.
|
Cohort 5: No Data Supplied to Par or HCP
n=85 Participants
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
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")
|
80.9 Percentage of ELLIPTA doses
Standard Error 3.19
|
69.0 Percentage of ELLIPTA doses
Standard Error 3.19
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 4 to Month 6Population: ITT Population. Only those participants with adherence data observed/imputed at the specified time points were analyzed.
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.
Outcome measures
| Measure |
Cohort 1: Data on Maintenance Use Supplied to Par and HCP
n=84 Participants
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.
|
Cohort 5: No Data Supplied to Par or HCP
n=84 Participants
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.
|
Cohort 4: Data on Maintenance and Rescue Use Supplied to Par
n=82 Participants
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.
|
Cohort 5: No Data Supplied to Par or HCP
n=85 Participants
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.
|
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.
|
|---|---|---|---|---|---|
|
Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 4 and Month 6 as Determined by the Maintenance Sensor
|
77.2 Percentage of ELLIPTA doses
Standard Error 3.04
|
78.3 Percentage of ELLIPTA doses
Standard Error 3.11
|
77.1 Percentage of ELLIPTA doses
Standard Error 3.25
|
69.0 Percentage of ELLIPTA doses
Standard Error 3.19
|
—
|
SECONDARY outcome
Timeframe: Month 1 to Month 3Population: ITT Population. Only those participants with adherence data observed/imputed at the specified time points were analyzed.
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.
Outcome measures
| Measure |
Cohort 1: Data on Maintenance Use Supplied to Par and HCP
n=86 Participants
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.
|
Cohort 5: No Data Supplied to Par or HCP
n=87 Participants
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.
|
Cohort 4: Data on Maintenance and Rescue Use Supplied to Par
n=88 Participants
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.
|
Cohort 5: No Data Supplied to Par or HCP
n=88 Participants
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.
|
Cohort 5: No Data Supplied to Par or HCP
n=86 Participants
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.
|
|---|---|---|---|---|---|
|
Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 1 and Month 3 as Determined by the Maintenance Sensor
|
85.7 Percentage of ELLIPTA doses
Standard Error 2.82
|
84.2 Percentage of ELLIPTA doses
Standard Error 2.66
|
82.0 Percentage of ELLIPTA doses
Standard Error 2.74
|
79.2 Percentage of ELLIPTA doses
Standard Error 2.78
|
76.4 Percentage of ELLIPTA doses
Standard Error 2.82
|
SECONDARY outcome
Timeframe: Month 1 to Month 6Population: ITT Population. Only those participants with adherence data observed/imputed at the specified time points were analyzed.
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.
Outcome measures
| Measure |
Cohort 1: Data on Maintenance Use Supplied to Par and HCP
n=86 Participants
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.
|
Cohort 5: No Data Supplied to Par or HCP
n=87 Participants
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.
|
Cohort 4: Data on Maintenance and Rescue Use Supplied to Par
n=88 Participants
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.
|
Cohort 5: No Data Supplied to Par or HCP
n=88 Participants
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.
|
Cohort 5: No Data Supplied to Par or HCP
n=86 Participants
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.
|
|---|---|---|---|---|---|
|
Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 1 and Month 6 as Determined by the Maintenance Sensor
|
81.5 Percentage of ELLIPTA doses
Standard Error 3.07
|
78.8 Percentage of ELLIPTA doses
Standard Error 2.90
|
77.7 Percentage of ELLIPTA doses
Standard Error 2.99
|
75.2 Percentage of ELLIPTA doses
Standard Error 3.03
|
71.8 Percentage of ELLIPTA doses
Standard Error 3.07
|
SECONDARY outcome
Timeframe: Month 4 to Month 6Population: ITT Population. Only those participants with rescue data observed/imputed at the specified time points were analyzed.
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.
Outcome measures
| Measure |
Cohort 1: Data on Maintenance Use Supplied to Par and HCP
n=87 Participants
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.
|
Cohort 5: No Data Supplied to Par or HCP
n=88 Participants
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.
|
Cohort 4: Data on Maintenance and Rescue Use Supplied to Par
n=88 Participants
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.
|
Cohort 5: No Data Supplied to Par or HCP
n=88 Participants
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.
|
Cohort 5: No Data Supplied to Par or HCP
n=85 Participants
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.
|
|---|---|---|---|---|---|
|
Percentage of Rescue Free Days Between Month 4 and Month 6 as Determined by the Rescue Medication Sensor
|
81.1 Percentage of rescue free days
Standard Error 2.82
|
81.2 Percentage of rescue free days
Standard Error 2.66
|
85.6 Percentage of rescue free days
Standard Error 2.76
|
83.7 Percentage of rescue free days
Standard Error 2.80
|
76.4 Percentage of rescue free days
Standard Error 2.82
|
SECONDARY outcome
Timeframe: Month 4 to Month 6Population: ITT Population. Only those participants with data available at the specified data points were analyzed.
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.
Outcome measures
| Measure |
Cohort 1: Data on Maintenance Use Supplied to Par and HCP
n=83 Participants
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.
|
Cohort 5: No Data Supplied to Par or HCP
n=84 Participants
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.
|
Cohort 4: Data on Maintenance and Rescue Use Supplied to Par
n=85 Participants
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.
|
Cohort 5: No Data Supplied to Par or HCP
n=82 Participants
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.
|
Cohort 5: No Data Supplied to Par or HCP
n=85 Participants
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.
|
|---|---|---|---|---|---|
|
Number of Doses of Rescue Medication Use Between Month 4 and Month 6 as Determined by the Rescue Medication Sensor
|
55.3 Doses of rescue medication
Standard Deviation 107.73
|
40.6 Doses of rescue medication
Standard Deviation 91.53
|
29.5 Doses of rescue medication
Standard Deviation 54.41
|
27.0 Doses of rescue medication
Standard Deviation 45.27
|
55.8 Doses of rescue medication
Standard Deviation 158.49
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: ITT Population. Only those participants with data available at the specified data points were analyzed.
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.
Outcome measures
| Measure |
Cohort 1: Data on Maintenance Use Supplied to Par and HCP
n=82 Participants
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.
|
Cohort 5: No Data Supplied to Par or HCP
n=82 Participants
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.
|
Cohort 4: Data on Maintenance and Rescue Use Supplied to Par
n=78 Participants
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.
|
Cohort 5: No Data Supplied to Par or HCP
n=78 Participants
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.
|
Cohort 5: No Data Supplied to Par or HCP
n=82 Participants
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.
|
|---|---|---|---|---|---|
|
Change From Baseline in Asthma Control Test (ACT) Total Score
|
3.4 Scores on a Scale
Standard Error 0.40
|
4.3 Scores on a Scale
Standard Error 0.40
|
4.7 Scores on a Scale
Standard Error 0.41
|
4.2 Scores on a Scale
Standard Error 0.41
|
3.9 Scores on a Scale
Standard Error 0.40
|
SECONDARY outcome
Timeframe: Month 6Population: ITT Population
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.
Outcome measures
| Measure |
Cohort 1: Data on Maintenance Use Supplied to Par and HCP
n=87 Participants
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.
|
Cohort 5: No Data Supplied to Par or HCP
n=88 Participants
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.
|
Cohort 4: Data on Maintenance and Rescue Use Supplied to Par
n=88 Participants
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.
|
Cohort 5: No Data Supplied to Par or HCP
n=88 Participants
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.
|
Cohort 5: No Data Supplied to Par or HCP
n=86 Participants
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.
|
|---|---|---|---|---|---|
|
Percentage of Participants Attaining Asthma Control (Percentage of Participants With an ACT Total Score >=20) at Month 6
|
52 Percentage of participants
|
66 Percentage of participants
|
55 Percentage of participants
|
53 Percentage of participants
|
62 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: ITT Population
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.
Outcome measures
| Measure |
Cohort 1: Data on Maintenance Use Supplied to Par and HCP
n=87 Participants
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.
|
Cohort 5: No Data Supplied to Par or HCP
n=88 Participants
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.
|
Cohort 4: Data on Maintenance and Rescue Use Supplied to Par
n=88 Participants
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.
|
Cohort 5: No Data Supplied to Par or HCP
n=88 Participants
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.
|
Cohort 5: No Data Supplied to Par or HCP
n=86 Participants
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.
|
|---|---|---|---|---|---|
|
Percentage of Participants With an Increase From Baseline >=3 in ACT Total Score at Month 6
|
61 Percentage of participants
|
69 Percentage of participants
|
65 Percentage of participants
|
63 Percentage of participants
|
64 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: ITT Population
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.
Outcome measures
| Measure |
Cohort 1: Data on Maintenance Use Supplied to Par and HCP
n=87 Participants
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.
|
Cohort 5: No Data Supplied to Par or HCP
n=88 Participants
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.
|
Cohort 4: Data on Maintenance and Rescue Use Supplied to Par
n=88 Participants
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.
|
Cohort 5: No Data Supplied to Par or HCP
n=88 Participants
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.
|
Cohort 5: No Data Supplied to Par or HCP
n=86 Participants
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.
|
|---|---|---|---|---|---|
|
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
|
66 Percentage of participants
|
75 Percentage of participants
|
65 Percentage of participants
|
67 Percentage of participants
|
70 Percentage of participants
|
Adverse Events
Cohort 1: Data on Maintenance Use Supplied to Par and HCP
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 2: Data on Maintenance Use Supplied to Par
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 3: Data on Maintenance and Rescue Use to Par and HCP
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 4: Data on Maintenance and Rescue Use Supplied to Par
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 5: No Data Supplied to Par or HCP
Serious events: 4 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: Data on Maintenance Use Supplied to Par and HCP
n=87 participants at risk
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.
|
Cohort 2: Data on Maintenance Use Supplied to Par
n=88 participants at risk
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.
|
Cohort 3: Data on Maintenance and Rescue Use to Par and HCP
n=88 participants at risk
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.
|
Cohort 4: Data on Maintenance and Rescue Use Supplied to Par
n=88 participants at risk
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.
|
Cohort 5: No Data Supplied to Par or HCP
n=86 participants at risk
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.
|
|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
1.1%
1/87 • 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.
|
0.00%
0/88 • 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.
|
0.00%
0/88 • 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.
|
0.00%
0/88 • 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.
|
1.2%
1/86 • 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.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/87 • 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.
|
0.00%
0/88 • 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.
|
0.00%
0/88 • 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.
|
0.00%
0/88 • 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.
|
1.2%
1/86 • 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.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
1.1%
1/87 • 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.
|
0.00%
0/88 • 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.
|
0.00%
0/88 • 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.
|
0.00%
0/88 • 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.
|
0.00%
0/86 • 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.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/87 • 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.
|
0.00%
0/88 • 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.
|
0.00%
0/88 • 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.
|
0.00%
0/88 • 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.
|
1.2%
1/86 • 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.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/87 • 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.
|
0.00%
0/88 • 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.
|
1.1%
1/88 • 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.
|
0.00%
0/88 • 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.
|
0.00%
0/86 • 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.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
1.1%
1/87 • 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.
|
0.00%
0/88 • 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.
|
0.00%
0/88 • 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.
|
0.00%
0/88 • 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.
|
0.00%
0/86 • 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.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/87 • 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.
|
0.00%
0/88 • 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.
|
0.00%
0/88 • 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.
|
1.1%
1/88 • 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.
|
0.00%
0/86 • 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.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/87 • 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.
|
0.00%
0/88 • 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.
|
0.00%
0/88 • 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.
|
1.1%
1/88 • 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.
|
0.00%
0/86 • 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.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.1%
1/87 • 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.
|
0.00%
0/88 • 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.
|
0.00%
0/88 • 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.
|
0.00%
0/88 • 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.
|
0.00%
0/86 • 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.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/87 • 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.
|
0.00%
0/88 • 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.
|
0.00%
0/88 • 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.
|
0.00%
0/88 • 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.
|
1.2%
1/86 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian germ cell teratoma
|
0.00%
0/87 • 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.
|
1.1%
1/88 • 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.
|
0.00%
0/88 • 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.
|
0.00%
0/88 • 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.
|
0.00%
0/86 • 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.
|
|
Nervous system disorders
Syncope
|
0.00%
0/87 • 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.
|
0.00%
0/88 • 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.
|
1.1%
1/88 • 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.
|
0.00%
0/88 • 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.
|
0.00%
0/86 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.1%
1/87 • 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.
|
0.00%
0/88 • 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.
|
0.00%
0/88 • 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.
|
0.00%
0/88 • 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.
|
0.00%
0/86 • 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.
|
Other adverse events
| Measure |
Cohort 1: Data on Maintenance Use Supplied to Par and HCP
n=87 participants at risk
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.
|
Cohort 2: Data on Maintenance Use Supplied to Par
n=88 participants at risk
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.
|
Cohort 3: Data on Maintenance and Rescue Use to Par and HCP
n=88 participants at risk
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.
|
Cohort 4: Data on Maintenance and Rescue Use Supplied to Par
n=88 participants at risk
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.
|
Cohort 5: No Data Supplied to Par or HCP
n=86 participants at risk
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.
|
|---|---|---|---|---|---|
|
Infections and infestations
Oral candidiasis
|
2.3%
2/87 • 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.
|
0.00%
0/88 • 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.
|
0.00%
0/88 • 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.
|
0.00%
0/88 • 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.
|
0.00%
0/86 • 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.
|
|
Infections and infestations
Oesophageal candidiasis
|
1.1%
1/87 • 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.
|
0.00%
0/88 • 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.
|
0.00%
0/88 • 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.
|
0.00%
0/88 • 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.
|
0.00%
0/86 • 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.
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/87 • 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.
|
1.1%
1/88 • 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.
|
0.00%
0/88 • 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.
|
0.00%
0/88 • 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.
|
0.00%
0/86 • 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.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/87 • 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.
|
0.00%
0/88 • 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.
|
1.1%
1/88 • 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.
|
0.00%
0/88 • 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.
|
0.00%
0/86 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
1.1%
1/87 • 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.
|
1.1%
1/88 • 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.
|
0.00%
0/88 • 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.
|
0.00%
0/88 • 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.
|
0.00%
0/86 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/87 • 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.
|
0.00%
0/88 • 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.
|
0.00%
0/88 • 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.
|
0.00%
0/88 • 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.
|
1.2%
1/86 • 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.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/87 • 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.
|
1.1%
1/88 • 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.
|
0.00%
0/88 • 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.
|
0.00%
0/88 • 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.
|
1.2%
1/86 • 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.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/87 • 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.
|
0.00%
0/88 • 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.
|
0.00%
0/88 • 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.
|
1.1%
1/88 • 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.
|
1.2%
1/86 • 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.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/87 • 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.
|
0.00%
0/88 • 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.
|
0.00%
0/88 • 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.
|
1.1%
1/88 • 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.
|
0.00%
0/86 • 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.
|
|
General disorders
Fatigue
|
0.00%
0/87 • 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.
|
0.00%
0/88 • 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.
|
0.00%
0/88 • 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.
|
0.00%
0/88 • 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.
|
1.2%
1/86 • 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.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/87 • 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.
|
1.1%
1/88 • 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.
|
0.00%
0/88 • 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.
|
0.00%
0/88 • 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.
|
0.00%
0/86 • 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.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/87 • 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.
|
1.1%
1/88 • 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.
|
0.00%
0/88 • 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.
|
0.00%
0/88 • 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.
|
0.00%
0/86 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER