Trial Outcomes & Findings for A Randomized Study, Comparing Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC /VI) Single Inhaler Triple Therapy, Versus Multiple Inhaler Therapy (Budesonide/Formoterol Plus Tiotropium) in Subjects With Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT03478696)
NCT ID: NCT03478696
Last Updated: 2020-10-28
Results Overview
FEV1 is an important measure of pulmonary function and is the maximum amount of air that can be forced out in one second after taking a deep breath. FEV1 was measured using spirometry. Serial FEV1 assessments were performed at multiple time points (-30 and -5 minutes pre-dose, and 5 minutes, 15 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, 12 hours, 15 hours, 21 hours, 23 hours and 24 hours post-dose) over 24-hour period at Week 12. Weighted mean change from Baseline at week 12 was calculated by subtracting weighted mean FEV1 at week 12 from Baseline FEV1, where Baseline FEV1 is the average of the two FEV1 measurements made at 30 minutes and 5 minutes pre-dose on Day 1. The weighted mean was derived by calculating the area under the FEV1 time curve (AUC) over the actual time of assessment relative to the time of dosing (over 24-hour period) using the trapezoidal rule, and then dividing the value by the time interval (24-hour) over which the AUC was calculated.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
732 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2020-10-28
Participant Flow
This was a randomized, multicenter, double blind, parallel group study where participants with chronic obstructive pulmonary disease (COPD) were randomized to receive either fluticasone furoate/umeclidinium/vilanterol or budesonide/formoterol plus tiotropium in a 1:1 ratio. The study was conducted across 60 centers in 3 countries.
A total of 1120 participants were screened in the study, of which 289 participants failed during screening. Of the 831 participants who entered the run-in period, 99 participants were run-in failures. A total of 732 participants were randomized and received randomized treatment.
Participant milestones
| Measure |
Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg
Participants received fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 microgram (mcg) via the ELLIPTA (once daily in the morning) plus placebo to match budesonide/formoterol (BUD/FOR) via metered dose inhaler (MDI) (two inhalations twice daily) plus placebo to match tiotropium (TIO) via HandiHaler (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication during conduct of the study, if required.
|
Budesonide/Formoterol 320/9 mcg Plus Tiotropium 18 mcg
Participants received two inhalations of budesonide/formoterol 160/4.5 mcg via MDI in the morning and two inhalations in the evening (total dose of 320/9 mcg twice daily) plus tiotropium 18 mcg via HandiHaler (once daily in the morning) plus placebo to match fluticasone furoate/umeclidinium/vilanterol via the ELLIPTA (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication during conduct of the study, if required.
|
|---|---|---|
|
Overall Study
STARTED
|
366
|
366
|
|
Overall Study
COMPLETED
|
349
|
354
|
|
Overall Study
NOT COMPLETED
|
17
|
12
|
Reasons for withdrawal
| Measure |
Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg
Participants received fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 microgram (mcg) via the ELLIPTA (once daily in the morning) plus placebo to match budesonide/formoterol (BUD/FOR) via metered dose inhaler (MDI) (two inhalations twice daily) plus placebo to match tiotropium (TIO) via HandiHaler (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication during conduct of the study, if required.
|
Budesonide/Formoterol 320/9 mcg Plus Tiotropium 18 mcg
Participants received two inhalations of budesonide/formoterol 160/4.5 mcg via MDI in the morning and two inhalations in the evening (total dose of 320/9 mcg twice daily) plus tiotropium 18 mcg via HandiHaler (once daily in the morning) plus placebo to match fluticasone furoate/umeclidinium/vilanterol via the ELLIPTA (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication during conduct of the study, if required.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
5
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Physician Decision
|
6
|
3
|
|
Overall Study
Withdrawal by Subject
|
9
|
4
|
Baseline Characteristics
A Randomized Study, Comparing Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC /VI) Single Inhaler Triple Therapy, Versus Multiple Inhaler Therapy (Budesonide/Formoterol Plus Tiotropium) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Baseline characteristics by cohort
| Measure |
Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg
n=366 Participants
Participants received fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 microgram (mcg) via the ELLIPTA (once daily in the morning) plus placebo to match budesonide/formoterol (BUD/FOR) via metered dose inhaler (MDI) (two inhalations twice daily) plus placebo to match tiotropium (TIO) via HandiHaler (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication during conduct of the study, if required.
|
Budesonide/Formoterol 320/9 mcg Plus Tiotropium 18 mcg
n=366 Participants
Participants received two inhalations of budesonide/formoterol 160/4.5 mcg via MDI in the morning and two inhalations in the evening (total dose of 320/9 mcg twice daily) plus tiotropium 18 mcg via HandiHaler (once daily in the morning) plus placebo to match fluticasone furoate/umeclidinium/vilanterol via the ELLIPTA (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication during conduct of the study, if required.
|
Total
n=732 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.5 Years
STANDARD_DEVIATION 8.15 • n=5 Participants
|
65.1 Years
STANDARD_DEVIATION 8.36 • n=7 Participants
|
65.3 Years
STANDARD_DEVIATION 8.26 • n=5 Participants
|
|
Sex: Female, Male
Female
|
180 Participants
n=5 Participants
|
179 Participants
n=7 Participants
|
359 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
186 Participants
n=5 Participants
|
187 Participants
n=7 Participants
|
373 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
43 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - Japanese Heritage
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - South East Asian Heritage
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - Arabic/North African Heritage
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
318 Participants
n=5 Participants
|
335 Participants
n=7 Participants
|
653 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: mPP Population comprised of all participants in the ITT population who do not have a protocol deviation of not meeting eligibility criteria or not meeting randomization criteria. Only those participants with data available at the specified time points were analyzed.
FEV1 is an important measure of pulmonary function and is the maximum amount of air that can be forced out in one second after taking a deep breath. FEV1 was measured using spirometry. Serial FEV1 assessments were performed at multiple time points (-30 and -5 minutes pre-dose, and 5 minutes, 15 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, 12 hours, 15 hours, 21 hours, 23 hours and 24 hours post-dose) over 24-hour period at Week 12. Weighted mean change from Baseline at week 12 was calculated by subtracting weighted mean FEV1 at week 12 from Baseline FEV1, where Baseline FEV1 is the average of the two FEV1 measurements made at 30 minutes and 5 minutes pre-dose on Day 1. The weighted mean was derived by calculating the area under the FEV1 time curve (AUC) over the actual time of assessment relative to the time of dosing (over 24-hour period) using the trapezoidal rule, and then dividing the value by the time interval (24-hour) over which the AUC was calculated.
Outcome measures
| Measure |
Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg
n=274 Participants
Participants received fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 microgram (mcg) via the ELLIPTA (once daily in the morning) plus placebo to match budesonide/formoterol (BUD/FOR) via metered dose inhaler (MDI) (two inhalations twice daily) plus placebo to match tiotropium (TIO) via HandiHaler (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication during conduct of the study, if required.
|
Budesonide/Formoterol 320/9 mcg Plus Tiotropium 18 mcg
n=277 Participants
Participants received two inhalations of budesonide/formoterol 160/4.5 mcg via MDI in the morning and two inhalations in the evening (total dose of 320/9 mcg twice daily) plus tiotropium 18 mcg via HandiHaler (once daily in the morning) plus placebo to match fluticasone furoate/umeclidinium/vilanterol via the ELLIPTA (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication during conduct of the study, if required.
|
|---|---|---|
|
Weighted Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Over 0-24 Hours at Week 12 for Modified Per Protocol (mPP) Population
|
0.039 Liters
Standard Error 0.0109
|
0.029 Liters
Standard Error 0.0109
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: ITT Population comprised of all randomized participants, excluding those who were randomized in error. Only those participants with data available at the specified time points were analyzed.
FEV1 is an important measure of pulmonary function and is the maximum amount of air that can be forced out in one second after taking a deep breath. FEV1 was measured using spirometry. Serial FEV1 assessments were performed at multiple time points (-30 and -5 minutes pre-dose, and 5 minutes, 15 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, 12 hours, 15 hours, 21 hours, 23 hours and 24 hours post-dose) over 24-hour period at Week 12. Weighted mean change from Baseline at week 12 was calculated by subtracting weighted mean FEV1 at week 12 from Baseline FEV1, where Baseline FEV1 is the average of the two FEV1 measurements made at 30 minutes and 5 minutes pre-dose on Day 1. The weighted mean was derived by calculating the area under the FEV1 time curve (AUC) over the actual time of assessment relative to the time of dosing (over 24-hour period) using the trapezoidal rule, and then dividing the value by the time interval (24-hour) over which the AUC was calculated.
Outcome measures
| Measure |
Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg
n=338 Participants
Participants received fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 microgram (mcg) via the ELLIPTA (once daily in the morning) plus placebo to match budesonide/formoterol (BUD/FOR) via metered dose inhaler (MDI) (two inhalations twice daily) plus placebo to match tiotropium (TIO) via HandiHaler (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication during conduct of the study, if required.
|
Budesonide/Formoterol 320/9 mcg Plus Tiotropium 18 mcg
n=333 Participants
Participants received two inhalations of budesonide/formoterol 160/4.5 mcg via MDI in the morning and two inhalations in the evening (total dose of 320/9 mcg twice daily) plus tiotropium 18 mcg via HandiHaler (once daily in the morning) plus placebo to match fluticasone furoate/umeclidinium/vilanterol via the ELLIPTA (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication during conduct of the study, if required.
|
|---|---|---|
|
Weighted Mean Change From Baseline in FEV1 Over 0-24 Hours at Week 12 for ITT Population
|
0.040 Liters
Standard Error 0.0099
|
0.023 Liters
Standard Error 0.0100
|
SECONDARY outcome
Timeframe: Baseline, Days 2, 28, 84 and 85Population: ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
FEV1 is an important measure of pulmonary function and is the maximum amount of air that can be forced out in one second after taking a deep breath. FEV1 was measured using spirometry. For Day 2 and Day 85, trough FEV1 was defined as the mean of the 23-hour and 24-hour serial spirometry FEV1 measurements. For Day 28 and Day 84, trough FEV1 was defined as the average of the pre-dose FEV1 measurements recorded before the morning dose of randomized study treatment. Change from Baseline in trough FEV1 was calculated by subtracting post-dose trough FEV1 value from Baseline FEV1, where Baseline FEV1 is the average of the two FEV1 measurements made at 30 minutes and 5 minutes pre-dose on Day 1. The treatment effect to be estimated for trough FEV1 was hypothetical effect if all participants stayed on their randomized study treatment. Only on treatment data was included in analysis.
Outcome measures
| Measure |
Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg
n=355 Participants
Participants received fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 microgram (mcg) via the ELLIPTA (once daily in the morning) plus placebo to match budesonide/formoterol (BUD/FOR) via metered dose inhaler (MDI) (two inhalations twice daily) plus placebo to match tiotropium (TIO) via HandiHaler (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication during conduct of the study, if required.
|
Budesonide/Formoterol 320/9 mcg Plus Tiotropium 18 mcg
n=354 Participants
Participants received two inhalations of budesonide/formoterol 160/4.5 mcg via MDI in the morning and two inhalations in the evening (total dose of 320/9 mcg twice daily) plus tiotropium 18 mcg via HandiHaler (once daily in the morning) plus placebo to match fluticasone furoate/umeclidinium/vilanterol via the ELLIPTA (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication during conduct of the study, if required.
|
|---|---|---|
|
Change From Baseline in Trough FEV1 on Day 2, Day 28, Day 84 and Day 85
Day 85, n=343,342
|
0.029 Liters
Standard Error 0.0111
|
-0.022 Liters
Standard Error 0.0111
|
|
Change From Baseline in Trough FEV1 on Day 2, Day 28, Day 84 and Day 85
Day 2, n=355,341
|
0.015 Liters
Standard Error 0.0086
|
-0.010 Liters
Standard Error 0.0087
|
|
Change From Baseline in Trough FEV1 on Day 2, Day 28, Day 84 and Day 85
Day 28, n=353,354
|
0.044 Liters
Standard Error 0.0095
|
-0.019 Liters
Standard Error 0.0095
|
|
Change From Baseline in Trough FEV1 on Day 2, Day 28, Day 84 and Day 85
Day 84, n=346,343
|
0.024 Liters
Standard Error 0.0101
|
-0.030 Liters
Standard Error 0.0102
|
SECONDARY outcome
Timeframe: Baseline and Day 1Population: ITT Population. Only those participants with data available at the specified time points were analyzed.
FEV1 is an important measure of pulmonary function and is the maximum amount of air that can be forced out in one second after taking a deep breath. FEV1 was measured using spirometry. Serial FEV1 assessments were performed at multiple time points (-30 and -5 minutes pre-dose, and 5 minutes, 15 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, 12 hours, 15 hours, 21 hours, 23 hours and 24 hours post-dose) over 24-hour period on Day 1. Weighted mean change from Baseline on Day 1 was calculated by subtracting weighted mean FEV1 on Day 1 from Baseline FEV1, where Baseline FEV1 is the average of the two FEV1 measurements made at 30 minutes and 5 minutes pre-dose on Day 1. The weighted mean was derived by calculating the area under the FEV1 time curve (AUC) over the actual time of assessment relative to the time of dosing (over 24-hour period) using the trapezoidal rule, and then dividing the value by the time interval (24-hour) over which the AUC was calculated.
Outcome measures
| Measure |
Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg
n=360 Participants
Participants received fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 microgram (mcg) via the ELLIPTA (once daily in the morning) plus placebo to match budesonide/formoterol (BUD/FOR) via metered dose inhaler (MDI) (two inhalations twice daily) plus placebo to match tiotropium (TIO) via HandiHaler (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication during conduct of the study, if required.
|
Budesonide/Formoterol 320/9 mcg Plus Tiotropium 18 mcg
n=356 Participants
Participants received two inhalations of budesonide/formoterol 160/4.5 mcg via MDI in the morning and two inhalations in the evening (total dose of 320/9 mcg twice daily) plus tiotropium 18 mcg via HandiHaler (once daily in the morning) plus placebo to match fluticasone furoate/umeclidinium/vilanterol via the ELLIPTA (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication during conduct of the study, if required.
|
|---|---|---|
|
Weighted Mean Change From Baseline in FEV1 Over 0-24 Hours on Day 1
|
0.045 Liters
Standard Error 0.0069
|
0.041 Liters
Standard Error 0.0070
|
Adverse Events
Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg
Serious events: 16 serious events
Other events: 20 other events
Deaths: 0 deaths
Budesonide/Formoterol 320/9 mcg Plus Tiotropium 18 mcg
Serious events: 20 serious events
Other events: 27 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg
n=366 participants at risk
Participants received fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 microgram (mcg) via the ELLIPTA (once daily in the morning) plus placebo to match budesonide/formoterol (BUD/FOR) via metered dose inhaler (MDI) (two inhalations twice daily) plus placebo to match tiotropium (TIO) via HandiHaler (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication during conduct of the study, if required.
|
Budesonide/Formoterol 320/9 mcg Plus Tiotropium 18 mcg
n=366 participants at risk
Participants received two inhalations of budesonide/formoterol 160/4.5 mcg via MDI in the morning and two inhalations in the evening (total dose of 320/9 mcg twice daily) plus tiotropium 18 mcg via HandiHaler (once daily in the morning) plus placebo to match fluticasone furoate/umeclidinium/vilanterol via the ELLIPTA (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication during conduct of the study, if required.
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.27%
1/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
0.00%
0/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
0.27%
1/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
0.27%
1/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.27%
1/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
0.00%
0/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
|
Cardiac disorders
Myocardial infarction
|
0.27%
1/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
0.00%
0/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
0.27%
1/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
|
Gastrointestinal disorders
Enteritis
|
0.27%
1/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
0.00%
0/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
0.27%
1/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
|
General disorders
Chest pain
|
0.27%
1/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
0.00%
0/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
|
General disorders
Hernia
|
0.00%
0/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
0.27%
1/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
0.27%
1/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
0.27%
1/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
0.27%
1/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
|
Infections and infestations
Influenza
|
0.27%
1/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
0.00%
0/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.27%
1/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
0.00%
0/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
|
Infections and infestations
Pneumonia
|
0.27%
1/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
0.27%
1/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
|
Infections and infestations
Sepsis
|
0.27%
1/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
0.00%
0/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
|
Infections and infestations
Urinary tract infection
|
0.27%
1/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
0.00%
0/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.27%
1/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
0.00%
0/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
|
Injury, poisoning and procedural complications
Fracture displacement
|
0.27%
1/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
0.00%
0/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
0.27%
1/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
0.27%
1/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
|
Musculoskeletal and connective tissue disorders
Knee deformity
|
0.27%
1/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
0.00%
0/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.27%
1/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
0.00%
0/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
0.27%
1/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.27%
1/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
0.00%
0/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
0.27%
1/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.00%
0/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
0.27%
1/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vulval cancer stage 0
|
0.27%
1/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
0.00%
0/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
0.27%
1/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
|
Nervous system disorders
Seizure
|
0.27%
1/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
0.00%
0/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
0.27%
1/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.55%
2/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
0.82%
3/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.6%
6/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
1.6%
6/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.27%
1/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
0.00%
0/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.55%
2/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
0.00%
0/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
Other adverse events
| Measure |
Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg
n=366 participants at risk
Participants received fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 microgram (mcg) via the ELLIPTA (once daily in the morning) plus placebo to match budesonide/formoterol (BUD/FOR) via metered dose inhaler (MDI) (two inhalations twice daily) plus placebo to match tiotropium (TIO) via HandiHaler (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication during conduct of the study, if required.
|
Budesonide/Formoterol 320/9 mcg Plus Tiotropium 18 mcg
n=366 participants at risk
Participants received two inhalations of budesonide/formoterol 160/4.5 mcg via MDI in the morning and two inhalations in the evening (total dose of 320/9 mcg twice daily) plus tiotropium 18 mcg via HandiHaler (once daily in the morning) plus placebo to match fluticasone furoate/umeclidinium/vilanterol via the ELLIPTA (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication during conduct of the study, if required.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
1.9%
7/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
5.2%
19/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
|
Nervous system disorders
Headache
|
3.6%
13/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
2.2%
8/366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment and up to Week 13
Non-SAEs and SAEs were reported for ITT Population. Adverse events were presented treatment-wise.
|
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