Trial Outcomes & Findings for To Evaluate Real-World Effectiveness of Fluticasone Furoate/Umeclidinium Bromide/Vilanterol (FF/UMEC/VI) in a Single Inhaler (Trelegy Ellipta) in Participants With Symptomatic COPD (NCT NCT05535972)
NCT ID: NCT05535972
Last Updated: 2025-12-11
Results Overview
The CAT is a validated 8-items questionnaire developed for use in routine clinical practice to measure the health status of participants with COPD. Participants rate their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment), higher score indicates greater impairment. A total CAT score was calculated by summing the non-missing scores of the eight items with a scoring range of 0 (no disease impact) to 40 (maximum disease impact). Higher scores indicated greater disease impact. Baseline was defined as the latest pre-dose of Trelegy assessment with a non-missing value, including those from unscheduled visits. Change from Baseline (CFB) was calculated by subtracting Baseline value from the post-dose visit value.
COMPLETED
PHASE4
463 participants
Baseline (Day 1, pre-dose) and at Week 12
2025-12-11
Participant Flow
A total of 463 participants were enrolled in this study, however only 460 participants (3 participants were never dosed) were dosed into the study to receive Trelegy creating the Full Analysis Set (FAS) (All participants who were enrolled into the study and took at least one dose of Trelegy).
Participant milestones
| Measure |
Trelegy (FF/UMEC/VI ELLIPTA)
Participants with symptomatic chronic obstructive pulmonary disease (COPD) received a single dose of Trelegy (fluticasone furoate \[FF\] 100 microgram \[ug\] / umeclidinium \[UMEC\] 62.5 ug / vilanterol \[VI\] 25 ug) in a single inhaler (TRELEGY ELLIPTA) via inhalation for 12 weeks.
|
|---|---|
|
Overall Study
STARTED
|
463
|
|
Overall Study
Full Analysis Set
|
460
|
|
Overall Study
COMPLETED
|
419
|
|
Overall Study
NOT COMPLETED
|
44
|
Reasons for withdrawal
| Measure |
Trelegy (FF/UMEC/VI ELLIPTA)
Participants with symptomatic chronic obstructive pulmonary disease (COPD) received a single dose of Trelegy (fluticasone furoate \[FF\] 100 microgram \[ug\] / umeclidinium \[UMEC\] 62.5 ug / vilanterol \[VI\] 25 ug) in a single inhaler (TRELEGY ELLIPTA) via inhalation for 12 weeks.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
31
|
|
Overall Study
Lost to Follow-up
|
5
|
|
Overall Study
Adverse Event
|
6
|
|
Overall Study
Protocol Deviation
|
2
|
Baseline Characteristics
To Evaluate Real-World Effectiveness of Fluticasone Furoate/Umeclidinium Bromide/Vilanterol (FF/UMEC/VI) in a Single Inhaler (Trelegy Ellipta) in Participants With Symptomatic COPD
Baseline characteristics by cohort
| Measure |
Trelegy (FF/UMEC/VI ELLIPTA)
n=460 Participants
Participants with symptomatic chronic obstructive pulmonary disease (COPD) received a single dose of Trelegy (fluticasone furoate \[FF\] 100 microgram \[ug\] / umeclidinium \[UMEC\] 62.5 ug / vilanterol \[VI\] 25 ug) in a single inhaler (TRELEGY ELLIPTA) via inhalation for 12 weeks.
|
|---|---|
|
Age, Continuous
|
68.74 Years
STANDARD_DEVIATION 8.118 • n=237 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=237 Participants
|
|
Sex: Female, Male
Male
|
434 Participants
n=237 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=237 Participants
|
|
Race (NIH/OMB)
Asian
|
460 Participants
n=237 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=237 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=237 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=237 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=237 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=237 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1, pre-dose) and at Week 12Population: Full Analysis Set included all participants who were enrolled into the study and took at least one dose of Trelegy. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field.
The CAT is a validated 8-items questionnaire developed for use in routine clinical practice to measure the health status of participants with COPD. Participants rate their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment), higher score indicates greater impairment. A total CAT score was calculated by summing the non-missing scores of the eight items with a scoring range of 0 (no disease impact) to 40 (maximum disease impact). Higher scores indicated greater disease impact. Baseline was defined as the latest pre-dose of Trelegy assessment with a non-missing value, including those from unscheduled visits. Change from Baseline (CFB) was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Trelegy (FF/UMEC/VI ELLIPTA)
n=422 Participants
Participants with symptomatic chronic obstructive pulmonary disease (COPD) received a single dose of Trelegy (fluticasone furoate \[FF\] 100 microgram \[ug\] / umeclidinium \[UMEC\] 62.5 ug / vilanterol \[VI\] 25 ug) in a single inhaler (TRELEGY ELLIPTA) via inhalation for 12 weeks.
|
|---|---|
|
Change From Baseline in COPD Assessment Test (CAT) Score at Week 12
|
-6.8 Scores on a scale
Standard Deviation 5.49
|
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-dose) and at Week 12Population: Full Analysis Set included all participants who were enrolled into the study and took at least one dose of Trelegy. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field.
mMRC(Patient Version\[Pt.V\]) was used to assess breathlessness state of participant before and after treatment. mMRC (Pt V) was completed by each participant firstly, without supervision.Participants were scored on a scale of 0 (no impact) to 4(worst possible impact) depending on their disability due to shortness of breath. Higher scores indicated greater disease impact;where 0=only get breathless with strenuous exercise;1=get short of breath when hurrying on the level/walking up a slight hill;2=walk slower than people of same age on the level because of breathlessness/have to stop for breath when walking at own pace on the level;3=stop for breath after walking about 100 yards/after a few minutes on the level;4=too breathless to leave house/breathless when dressing. Baseline=latest pre-dose of Trelegy assessment with a non-missing value, including those from unscheduled visits. Change from Baseline=post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Trelegy (FF/UMEC/VI ELLIPTA)
n=422 Participants
Participants with symptomatic chronic obstructive pulmonary disease (COPD) received a single dose of Trelegy (fluticasone furoate \[FF\] 100 microgram \[ug\] / umeclidinium \[UMEC\] 62.5 ug / vilanterol \[VI\] 25 ug) in a single inhaler (TRELEGY ELLIPTA) via inhalation for 12 weeks.
|
|---|---|
|
Change From Baseline in Modified Medical Research Council (mMRC) Grading System at Week 12 (Patient Version)
|
-0.5 Scores on a scale
Standard Deviation 0.91
|
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-dose) and at Week 12Population: Full Analysis Set included all participants who were enrolled into the study and took at least one dose of Trelegy. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field.
mMRC(Physician Version\[PV\]) was used to assess breathlessness state of participant before and after treatment. Physicians completed mMRC(PV) through their observation. Participants were scored on a scale of 0 (no impact) to 4(worst possible impact) depending on their disability due to shortness of breath. Higher scores indicated greater disease impact; where 0=no breathlessness except on strenuous exercise; 1=shortness of breath when hurrying on the level ground or walking up a slight hill; 2=walks slower than people of same age on the level because of breathlessness or has to stop to catch breath when walking at their own pace on the level; 3=stops for breath after walking about 100 yards or after few minutes on level ground; 4=too breathless to leave house or breathless when dressing or undressing. Baseline=latest pre-dose of Trelegy assessment with a non-missing value, including those from unscheduled visits. Change from Baseline=post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Trelegy (FF/UMEC/VI ELLIPTA)
n=422 Participants
Participants with symptomatic chronic obstructive pulmonary disease (COPD) received a single dose of Trelegy (fluticasone furoate \[FF\] 100 microgram \[ug\] / umeclidinium \[UMEC\] 62.5 ug / vilanterol \[VI\] 25 ug) in a single inhaler (TRELEGY ELLIPTA) via inhalation for 12 weeks.
|
|---|---|
|
Change From Baseline in Modified Medical Research Council (mMRC) Dyspnea Scale at Week 12 (Physician Version)
|
-0.5 Scores on a scale
Standard Deviation 0.89
|
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-dose) and at Week 12Population: Full Analysis Set included all participants who were enrolled into the study and took at least one dose of Trelegy. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field.
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using spirometry. Baseline was defined as the latest pre-dose of Trelegy assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Trelegy (FF/UMEC/VI ELLIPTA)
n=411 Participants
Participants with symptomatic chronic obstructive pulmonary disease (COPD) received a single dose of Trelegy (fluticasone furoate \[FF\] 100 microgram \[ug\] / umeclidinium \[UMEC\] 62.5 ug / vilanterol \[VI\] 25 ug) in a single inhaler (TRELEGY ELLIPTA) via inhalation for 12 weeks.
|
|---|---|
|
Change From Baseline in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) at Week 12
|
0.132 Liters
Standard Deviation 0.2897
|
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-dose) and at Week 12Population: Full Analysis Set included all participants who were enrolled into the study and took at least one dose of Trelegy. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field.
The CAT is a validated 8-items questionnaire developed for use in routine clinical practice to measure the health status of participants with COPD. Participants rate their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment), higher score indicates greater impairment. A total CAT score was calculated by summing the non-missing scores of the eight items with a scoring range of 0 (no disease impact) to 40 (maximum disease impact). Higher scores indicated greater disease impact. Baseline was defined as the latest pre-dose of Trelegy assessment with a non-missing value, including those from unscheduled visits. Percentage values are rounded-off. Percentage of participants having \>=2 unit decrease in CAT score from Baseline at week 12 has been presented.
Outcome measures
| Measure |
Trelegy (FF/UMEC/VI ELLIPTA)
n=422 Participants
Participants with symptomatic chronic obstructive pulmonary disease (COPD) received a single dose of Trelegy (fluticasone furoate \[FF\] 100 microgram \[ug\] / umeclidinium \[UMEC\] 62.5 ug / vilanterol \[VI\] 25 ug) in a single inhaler (TRELEGY ELLIPTA) via inhalation for 12 weeks.
|
|---|---|
|
Percentage of Participants Having >=2 Unit Decrease in CAT Score From Baseline at Week 12
|
86.0 Percentage of Participants
Interval 82.7 to 89.3
|
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-dose) and at Week 4Population: Full Analysis Set included all participants who were enrolled into the study and took at least one dose of Trelegy. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field.
The CAT is a validated 8-items questionnaire developed for use in routine clinical practice to measure the health status of participants with COPD. Participants rate their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment), higher score indicates greater impairment. A total CAT score was calculated by summing the non-missing scores of the eight items with a scoring range of 0 (no disease impact) to 40 (maximum disease impact). Higher scores indicated greater disease impact. Baseline was defined as the latest pre-dose of Trelegy assessment with a non-missing value, including those from unscheduled visits. Change from Baseline (CFB) was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Trelegy (FF/UMEC/VI ELLIPTA)
n=439 Participants
Participants with symptomatic chronic obstructive pulmonary disease (COPD) received a single dose of Trelegy (fluticasone furoate \[FF\] 100 microgram \[ug\] / umeclidinium \[UMEC\] 62.5 ug / vilanterol \[VI\] 25 ug) in a single inhaler (TRELEGY ELLIPTA) via inhalation for 12 weeks.
|
|---|---|
|
Change From Baseline in COPD Assessment Test (CAT) Score at Week 4
|
-4.4 Scores on a scale
Standard Deviation 5.29
|
SECONDARY outcome
Timeframe: Up to 251 daysPopulation: Full Analysis Set included all participants who were enrolled into the study and took at least one dose of Trelegy.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
Outcome measures
| Measure |
Trelegy (FF/UMEC/VI ELLIPTA)
n=460 Participants
Participants with symptomatic chronic obstructive pulmonary disease (COPD) received a single dose of Trelegy (fluticasone furoate \[FF\] 100 microgram \[ug\] / umeclidinium \[UMEC\] 62.5 ug / vilanterol \[VI\] 25 ug) in a single inhaler (TRELEGY ELLIPTA) via inhalation for 12 weeks.
|
|---|---|
|
Number of Participants With Trelegy Related Non-serious Adverse Events (AEs)
|
9 Participants
|
SECONDARY outcome
Timeframe: Up to 251 daysPopulation: Full Analysis Set included all participants who were enrolled into the study and took at least one dose of Trelegy.
A SAE is defined as any serious adverse event that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, a suspected transmission of any infectious agent via an authorized medicinal product or other situations as judged by physician.
Outcome measures
| Measure |
Trelegy (FF/UMEC/VI ELLIPTA)
n=460 Participants
Participants with symptomatic chronic obstructive pulmonary disease (COPD) received a single dose of Trelegy (fluticasone furoate \[FF\] 100 microgram \[ug\] / umeclidinium \[UMEC\] 62.5 ug / vilanterol \[VI\] 25 ug) in a single inhaler (TRELEGY ELLIPTA) via inhalation for 12 weeks.
|
|---|---|
|
Number of Participants With Trelegy Related Serious Adverse Events (SAEs)
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 251 daysPopulation: Full Analysis Set included all participants who were enrolled into the study and took at least one dose of Trelegy.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
Outcome measures
| Measure |
Trelegy (FF/UMEC/VI ELLIPTA)
n=460 Participants
Participants with symptomatic chronic obstructive pulmonary disease (COPD) received a single dose of Trelegy (fluticasone furoate \[FF\] 100 microgram \[ug\] / umeclidinium \[UMEC\] 62.5 ug / vilanterol \[VI\] 25 ug) in a single inhaler (TRELEGY ELLIPTA) via inhalation for 12 weeks.
|
|---|---|
|
Number of Participants With Trelegy Related AEs Leading to the Discontinuation
|
5 Participants
|
Adverse Events
Trelegy (FF/UMEC/VI ELLIPTA)
Serious adverse events
| Measure |
Trelegy (FF/UMEC/VI ELLIPTA)
n=460 participants at risk
Participants with symptomatic chronic obstructive pulmonary disease (COPD) received a single dose of Trelegy (fluticasone furoate \[FF\] 100 microgram \[ug\] / umeclidinium \[UMEC\] 62.5 ug / vilanterol \[VI\] 25 ug) in a single inhaler (TRELEGY ELLIPTA) via inhalation for 12 weeks.
|
|---|---|
|
Infections and infestations
COVID-19
|
0.65%
3/460 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 251 days
All-cause mortality, serious adverse events and non-serious adverse events were reported for the Full Analysis Set (FAS). FAS included all participants who were enrolled in the study and took at least one dose of Trelegy. Three participants from Enrolled Population (N=463) did not receive study treatment, hence was not included in FAS Population (N=460).
|
|
Infections and infestations
Lower respiratory tract infection
|
0.22%
1/460 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 251 days
All-cause mortality, serious adverse events and non-serious adverse events were reported for the Full Analysis Set (FAS). FAS included all participants who were enrolled in the study and took at least one dose of Trelegy. Three participants from Enrolled Population (N=463) did not receive study treatment, hence was not included in FAS Population (N=460).
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.22%
1/460 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 251 days
All-cause mortality, serious adverse events and non-serious adverse events were reported for the Full Analysis Set (FAS). FAS included all participants who were enrolled in the study and took at least one dose of Trelegy. Three participants from Enrolled Population (N=463) did not receive study treatment, hence was not included in FAS Population (N=460).
|
|
Infections and infestations
Viral infection
|
0.22%
1/460 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 251 days
All-cause mortality, serious adverse events and non-serious adverse events were reported for the Full Analysis Set (FAS). FAS included all participants who were enrolled in the study and took at least one dose of Trelegy. Three participants from Enrolled Population (N=463) did not receive study treatment, hence was not included in FAS Population (N=460).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.43%
2/460 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 251 days
All-cause mortality, serious adverse events and non-serious adverse events were reported for the Full Analysis Set (FAS). FAS included all participants who were enrolled in the study and took at least one dose of Trelegy. Three participants from Enrolled Population (N=463) did not receive study treatment, hence was not included in FAS Population (N=460).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.22%
1/460 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 251 days
All-cause mortality, serious adverse events and non-serious adverse events were reported for the Full Analysis Set (FAS). FAS included all participants who were enrolled in the study and took at least one dose of Trelegy. Three participants from Enrolled Population (N=463) did not receive study treatment, hence was not included in FAS Population (N=460).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.22%
1/460 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 251 days
All-cause mortality, serious adverse events and non-serious adverse events were reported for the Full Analysis Set (FAS). FAS included all participants who were enrolled in the study and took at least one dose of Trelegy. Three participants from Enrolled Population (N=463) did not receive study treatment, hence was not included in FAS Population (N=460).
|
|
Cardiac disorders
Arrhythmia
|
0.22%
1/460 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 251 days
All-cause mortality, serious adverse events and non-serious adverse events were reported for the Full Analysis Set (FAS). FAS included all participants who were enrolled in the study and took at least one dose of Trelegy. Three participants from Enrolled Population (N=463) did not receive study treatment, hence was not included in FAS Population (N=460).
|
|
Cardiac disorders
Coronary artery disease
|
0.22%
1/460 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 251 days
All-cause mortality, serious adverse events and non-serious adverse events were reported for the Full Analysis Set (FAS). FAS included all participants who were enrolled in the study and took at least one dose of Trelegy. Three participants from Enrolled Population (N=463) did not receive study treatment, hence was not included in FAS Population (N=460).
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.22%
1/460 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 251 days
All-cause mortality, serious adverse events and non-serious adverse events were reported for the Full Analysis Set (FAS). FAS included all participants who were enrolled in the study and took at least one dose of Trelegy. Three participants from Enrolled Population (N=463) did not receive study treatment, hence was not included in FAS Population (N=460).
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.22%
1/460 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 251 days
All-cause mortality, serious adverse events and non-serious adverse events were reported for the Full Analysis Set (FAS). FAS included all participants who were enrolled in the study and took at least one dose of Trelegy. Three participants from Enrolled Population (N=463) did not receive study treatment, hence was not included in FAS Population (N=460).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.22%
1/460 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 251 days
All-cause mortality, serious adverse events and non-serious adverse events were reported for the Full Analysis Set (FAS). FAS included all participants who were enrolled in the study and took at least one dose of Trelegy. Three participants from Enrolled Population (N=463) did not receive study treatment, hence was not included in FAS Population (N=460).
|
|
Nervous system disorders
Cerebral thrombosis
|
0.22%
1/460 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 251 days
All-cause mortality, serious adverse events and non-serious adverse events were reported for the Full Analysis Set (FAS). FAS included all participants who were enrolled in the study and took at least one dose of Trelegy. Three participants from Enrolled Population (N=463) did not receive study treatment, hence was not included in FAS Population (N=460).
|
|
Nervous system disorders
Intracranial mass
|
0.22%
1/460 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 251 days
All-cause mortality, serious adverse events and non-serious adverse events were reported for the Full Analysis Set (FAS). FAS included all participants who were enrolled in the study and took at least one dose of Trelegy. Three participants from Enrolled Population (N=463) did not receive study treatment, hence was not included in FAS Population (N=460).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal tract adenoma
|
0.22%
1/460 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 251 days
All-cause mortality, serious adverse events and non-serious adverse events were reported for the Full Analysis Set (FAS). FAS included all participants who were enrolled in the study and took at least one dose of Trelegy. Three participants from Enrolled Population (N=463) did not receive study treatment, hence was not included in FAS Population (N=460).
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.22%
1/460 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 251 days
All-cause mortality, serious adverse events and non-serious adverse events were reported for the Full Analysis Set (FAS). FAS included all participants who were enrolled in the study and took at least one dose of Trelegy. Three participants from Enrolled Population (N=463) did not receive study treatment, hence was not included in FAS Population (N=460).
|
Other adverse events
| Measure |
Trelegy (FF/UMEC/VI ELLIPTA)
n=460 participants at risk
Participants with symptomatic chronic obstructive pulmonary disease (COPD) received a single dose of Trelegy (fluticasone furoate \[FF\] 100 microgram \[ug\] / umeclidinium \[UMEC\] 62.5 ug / vilanterol \[VI\] 25 ug) in a single inhaler (TRELEGY ELLIPTA) via inhalation for 12 weeks.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.43%
2/460 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 251 days
All-cause mortality, serious adverse events and non-serious adverse events were reported for the Full Analysis Set (FAS). FAS included all participants who were enrolled in the study and took at least one dose of Trelegy. Three participants from Enrolled Population (N=463) did not receive study treatment, hence was not included in FAS Population (N=460).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract irritation
|
0.22%
1/460 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 251 days
All-cause mortality, serious adverse events and non-serious adverse events were reported for the Full Analysis Set (FAS). FAS included all participants who were enrolled in the study and took at least one dose of Trelegy. Three participants from Enrolled Population (N=463) did not receive study treatment, hence was not included in FAS Population (N=460).
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.22%
1/460 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 251 days
All-cause mortality, serious adverse events and non-serious adverse events were reported for the Full Analysis Set (FAS). FAS included all participants who were enrolled in the study and took at least one dose of Trelegy. Three participants from Enrolled Population (N=463) did not receive study treatment, hence was not included in FAS Population (N=460).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.22%
1/460 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 251 days
All-cause mortality, serious adverse events and non-serious adverse events were reported for the Full Analysis Set (FAS). FAS included all participants who were enrolled in the study and took at least one dose of Trelegy. Three participants from Enrolled Population (N=463) did not receive study treatment, hence was not included in FAS Population (N=460).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.22%
1/460 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 251 days
All-cause mortality, serious adverse events and non-serious adverse events were reported for the Full Analysis Set (FAS). FAS included all participants who were enrolled in the study and took at least one dose of Trelegy. Three participants from Enrolled Population (N=463) did not receive study treatment, hence was not included in FAS Population (N=460).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.22%
1/460 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 251 days
All-cause mortality, serious adverse events and non-serious adverse events were reported for the Full Analysis Set (FAS). FAS included all participants who were enrolled in the study and took at least one dose of Trelegy. Three participants from Enrolled Population (N=463) did not receive study treatment, hence was not included in FAS Population (N=460).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.22%
1/460 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 251 days
All-cause mortality, serious adverse events and non-serious adverse events were reported for the Full Analysis Set (FAS). FAS included all participants who were enrolled in the study and took at least one dose of Trelegy. Three participants from Enrolled Population (N=463) did not receive study treatment, hence was not included in FAS Population (N=460).
|
|
Nervous system disorders
Dizziness
|
0.22%
1/460 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 251 days
All-cause mortality, serious adverse events and non-serious adverse events were reported for the Full Analysis Set (FAS). FAS included all participants who were enrolled in the study and took at least one dose of Trelegy. Three participants from Enrolled Population (N=463) did not receive study treatment, hence was not included in FAS Population (N=460).
|
|
Nervous system disorders
Headache
|
0.22%
1/460 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 251 days
All-cause mortality, serious adverse events and non-serious adverse events were reported for the Full Analysis Set (FAS). FAS included all participants who were enrolled in the study and took at least one dose of Trelegy. Three participants from Enrolled Population (N=463) did not receive study treatment, hence was not included in FAS Population (N=460).
|
|
General disorders
Chest discomfort
|
0.22%
1/460 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 251 days
All-cause mortality, serious adverse events and non-serious adverse events were reported for the Full Analysis Set (FAS). FAS included all participants who were enrolled in the study and took at least one dose of Trelegy. Three participants from Enrolled Population (N=463) did not receive study treatment, hence was not included in FAS Population (N=460).
|
|
Infections and infestations
Oral candidiasis
|
0.22%
1/460 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 251 days
All-cause mortality, serious adverse events and non-serious adverse events were reported for the Full Analysis Set (FAS). FAS included all participants who were enrolled in the study and took at least one dose of Trelegy. Three participants from Enrolled Population (N=463) did not receive study treatment, hence was not included in FAS Population (N=460).
|
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