Trial Outcomes & Findings for A Comparative Study Between Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) Single Inhaler Triple Therapy Versus Tiotropium Monotherapy in Subjects With Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT03474081)
NCT ID: NCT03474081
Last Updated: 2021-07-15
Results Overview
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Day 85 was defined as the mean of the two planned spirometry FEV1 measurements. Change from Baseline in trough FEV1 on Day 85 was calculated by subtracting Baseline FEV1 value from the trough FEV1 value on Day 85. Baseline FEV1 was defined as the mean of the two assessments made at 30 and 5 minutes pre-dose on Day 1.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
800 participants
Primary outcome timeframe
Baseline (Day 1 [Pre-dose at 30 minutes and 5 minutes]) and Day 85
Results posted on
2021-07-15
Participant Flow
This was a randomized, multicenter, parallel group study where participants with chronic obstructive pulmonary disease (COPD) were randomized to receive either fluticasone furoate/umeclidinium/vilanterol or tiotropium in a 1:1 ratio. The study was conducted across 68 centers in 3 countries.
A total of 1049 participants were screened, of which 179 failed screening. Total of 870 participants entered in run-in period, of which 70 were run-in failures. Total of 800 participants were enrolled and randomized.
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 tiotropium (TIO) via HandiHaler (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication via metered dose inhaler (MDI) during conduct of the study, if required.
|
Tiotropium 18 mcg
Participants received 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 via MDI during conduct of the study, if required.
|
|---|---|---|
|
Overall Study
STARTED
|
400
|
400
|
|
Overall Study
Received Study Treatment
|
400
|
399
|
|
Overall Study
COMPLETED
|
383
|
387
|
|
Overall Study
NOT COMPLETED
|
17
|
13
|
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 tiotropium (TIO) via HandiHaler (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication via metered dose inhaler (MDI) during conduct of the study, if required.
|
Tiotropium 18 mcg
Participants received 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 via MDI during conduct of the study, if required.
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Physician Decision
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
5
|
7
|
|
Overall Study
Investigator site closed
|
1
|
0
|
Baseline Characteristics
A Comparative Study Between Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) Single Inhaler Triple Therapy Versus Tiotropium Monotherapy in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Baseline characteristics by cohort
| Measure |
Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg
n=400 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 tiotropium (TIO) via HandiHaler (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication via metered dose inhaler (MDI) during conduct of the study, if required.
|
Tiotropium 18 mcg
n=400 Participants
Participants received 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 via MDI during conduct of the study, if required.
|
Total
n=800 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.2 Years
STANDARD_DEVIATION 8.08 • n=5 Participants
|
66.1 Years
STANDARD_DEVIATION 7.78 • n=7 Participants
|
66.2 Years
STANDARD_DEVIATION 7.93 • n=5 Participants
|
|
Sex: Female, Male
Female
|
126 Participants
n=5 Participants
|
131 Participants
n=7 Participants
|
257 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
274 Participants
n=5 Participants
|
269 Participants
n=7 Participants
|
543 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
390 Participants
n=5 Participants
|
388 Participants
n=7 Participants
|
778 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1 [Pre-dose at 30 minutes and 5 minutes]) and Day 85Population: Intent-To-Treat (ITT) Population comprised of all randomized participants, excluding those who were randomized in error. Only those participants with data available at the specified time point were analyzed.
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Day 85 was defined as the mean of the two planned spirometry FEV1 measurements. Change from Baseline in trough FEV1 on Day 85 was calculated by subtracting Baseline FEV1 value from the trough FEV1 value on Day 85. Baseline FEV1 was defined as the mean of the two assessments made at 30 and 5 minutes pre-dose on Day 1.
Outcome measures
| Measure |
Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg
n=362 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 tiotropium (TIO) via HandiHaler (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication via metered dose inhaler (MDI) during conduct of the study, if required.
|
Tiotropium 18 mcg
n=375 Participants
Participants received 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 via MDI during conduct of the study, if required.
|
|---|---|---|
|
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) on Day 85
|
0.115 Liters
Standard Error 0.0119
|
0.020 Liters
Standard Error 0.0117
|
SECONDARY outcome
Timeframe: Baseline (Day 1 [Pre-dose at 30 minutes and 5 minutes]) and Day 28Population: ITT Population. Only those participants with data available at the specified time point were analyzed.
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Day 28 was defined as the average of the two pre-dose FEV1 measurements recorded before the morning dose of randomized study medication on Day 28. Change from Baseline in trough FEV1 on Day 28 was calculated by subtracting Baseline FEV1 value from the trough FEV1 value on Day 28. Baseline FEV1 was defined as the mean of the two assessments made at 30 and 5 minutes pre-dose on Day 1.
Outcome measures
| Measure |
Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg
n=385 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 tiotropium (TIO) via HandiHaler (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication via metered dose inhaler (MDI) during conduct of the study, if required.
|
Tiotropium 18 mcg
n=390 Participants
Participants received 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 via MDI during conduct of the study, if required.
|
|---|---|---|
|
Change From Baseline in Trough FEV1 on Day 28
|
0.115 Liters
Standard Error 0.0102
|
-0.007 Liters
Standard Error 0.0101
|
SECONDARY outcome
Timeframe: Baseline (Day 1 [Pre-dose at 30 minutes and 5 minutes]) and Day 84Population: ITT Population. Only those participants with data available at the specified time point were analyzed.
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Day 84 was defined as the average of the two pre-dose FEV1 measurements recorded before the morning dose of randomized study medication on Day 84. Change from Baseline in trough FEV1 on Day 84 was calculated by subtracting Baseline FEV1 value from the trough FEV1 value on Day 84. Baseline FEV1 was defined as the mean of the two assessments made at 30 and 5 minutes pre-dose on Day 1.
Outcome measures
| Measure |
Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg
n=376 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 tiotropium (TIO) via HandiHaler (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication via metered dose inhaler (MDI) during conduct of the study, if required.
|
Tiotropium 18 mcg
n=386 Participants
Participants received 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 via MDI during conduct of the study, if required.
|
|---|---|---|
|
Change From Baseline in Trough FEV1 on Day 84
|
0.105 Liters
Standard Error 0.0113
|
0.018 Liters
Standard Error 0.0111
|
SECONDARY outcome
Timeframe: Up to Day 95Population: ITT Population. Non-SAEs and SAEs were presented for all randomized participants excluding one participant in ITT population who was randomized correctly to "Tiotropium 18 mcg" arm but did not take any randomized study treatment due to withdrawal of consent.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other important medical event according to medical or scientific judgement was categorized as SAE.
Outcome measures
| Measure |
Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg
n=400 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 tiotropium (TIO) via HandiHaler (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication via metered dose inhaler (MDI) during conduct of the study, if required.
|
Tiotropium 18 mcg
n=399 Participants
Participants received 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 via MDI during conduct of the study, if required.
|
|---|---|---|
|
Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)
Non-SAEs
|
31 Participants
|
29 Participants
|
|
Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)
SAEs
|
13 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose) and Day 84Population: ITT Population. Only those participants with data available at the specified time points were analyzed.
SBP and DBP were assessed in the sitting position after approximately 5 minutes rest. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-first-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg
n=387 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 tiotropium (TIO) via HandiHaler (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication via metered dose inhaler (MDI) during conduct of the study, if required.
|
Tiotropium 18 mcg
n=392 Participants
Participants received 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 via MDI during conduct of the study, if required.
|
|---|---|---|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP
|
-0.3 Millimeters of mercury
Standard Deviation 12.53
|
-0.1 Millimeters of mercury
Standard Deviation 11.02
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP
|
-0.3 Millimeters of mercury
Standard Deviation 8.17
|
-0.7 Millimeters of mercury
Standard Deviation 7.88
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose) and Day 84Population: ITT Population. Only those participants with data available at the specified time points were analyzed.
Pulse rate was assessed in the sitting position after approximately 5 minutes rest. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-first-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg
n=387 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 tiotropium (TIO) via HandiHaler (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication via metered dose inhaler (MDI) during conduct of the study, if required.
|
Tiotropium 18 mcg
n=392 Participants
Participants received 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 via MDI during conduct of the study, if required.
|
|---|---|---|
|
Change From Baseline in Pulse Rate
|
0.2 Beats per minute
Standard Deviation 8.55
|
0.8 Beats per minute
Standard Deviation 8.51
|
Adverse Events
Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg
Serious events: 13 serious events
Other events: 31 other events
Deaths: 2 deaths
Tiotropium 18 mcg
Serious events: 11 serious events
Other events: 29 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg
n=400 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 tiotropium (TIO) via HandiHaler (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication via metered dose inhaler (MDI) during conduct of the study, if required.
|
Tiotropium 18 mcg
n=399 participants at risk
Participants received 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 via MDI during conduct of the study, if required.
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/400 • Non-SAEs and SAEs were reported from start of study treatment and up to 95 days
Non-SAEs and SAEs were presented for all randomized participants excluding one randomized participant who withdrew consent and never received study treatment in "Tiotropium 18 mcg" arm. Adverse events were presented treatment-wise.
|
0.25%
1/399 • Number of events 1 • Non-SAEs and SAEs were reported from start of study treatment and up to 95 days
Non-SAEs and SAEs were presented for all randomized participants excluding one randomized participant who withdrew consent and never received study treatment in "Tiotropium 18 mcg" arm. Adverse events were presented treatment-wise.
|
|
Cardiac disorders
Cardiac arrest
|
0.25%
1/400 • Number of events 1 • Non-SAEs and SAEs were reported from start of study treatment and up to 95 days
Non-SAEs and SAEs were presented for all randomized participants excluding one randomized participant who withdrew consent and never received study treatment in "Tiotropium 18 mcg" arm. Adverse events were presented treatment-wise.
|
0.00%
0/399 • Non-SAEs and SAEs were reported from start of study treatment and up to 95 days
Non-SAEs and SAEs were presented for all randomized participants excluding one randomized participant who withdrew consent and never received study treatment in "Tiotropium 18 mcg" arm. Adverse events were presented treatment-wise.
|
|
Cardiac disorders
Cardiac failure
|
0.25%
1/400 • Number of events 1 • Non-SAEs and SAEs were reported from start of study treatment and up to 95 days
Non-SAEs and SAEs were presented for all randomized participants excluding one randomized participant who withdrew consent and never received study treatment in "Tiotropium 18 mcg" arm. Adverse events were presented treatment-wise.
|
0.00%
0/399 • Non-SAEs and SAEs were reported from start of study treatment and up to 95 days
Non-SAEs and SAEs were presented for all randomized participants excluding one randomized participant who withdrew consent and never received study treatment in "Tiotropium 18 mcg" arm. Adverse events were presented treatment-wise.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.25%
1/400 • Number of events 1 • Non-SAEs and SAEs were reported from start of study treatment and up to 95 days
Non-SAEs and SAEs were presented for all randomized participants excluding one randomized participant who withdrew consent and never received study treatment in "Tiotropium 18 mcg" arm. Adverse events were presented treatment-wise.
|
0.25%
1/399 • Number of events 1 • Non-SAEs and SAEs were reported from start of study treatment and up to 95 days
Non-SAEs and SAEs were presented for all randomized participants excluding one randomized participant who withdrew consent and never received study treatment in "Tiotropium 18 mcg" arm. Adverse events were presented treatment-wise.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.25%
1/400 • Number of events 1 • Non-SAEs and SAEs were reported from start of study treatment and up to 95 days
Non-SAEs and SAEs were presented for all randomized participants excluding one randomized participant who withdrew consent and never received study treatment in "Tiotropium 18 mcg" arm. Adverse events were presented treatment-wise.
|
0.25%
1/399 • Number of events 1 • Non-SAEs and SAEs were reported from start of study treatment and up to 95 days
Non-SAEs and SAEs were presented for all randomized participants excluding one randomized participant who withdrew consent and never received study treatment in "Tiotropium 18 mcg" arm. Adverse events were presented treatment-wise.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/400 • Non-SAEs and SAEs were reported from start of study treatment and up to 95 days
Non-SAEs and SAEs were presented for all randomized participants excluding one randomized participant who withdrew consent and never received study treatment in "Tiotropium 18 mcg" arm. Adverse events were presented treatment-wise.
|
0.25%
1/399 • Number of events 1 • Non-SAEs and SAEs were reported from start of study treatment and up to 95 days
Non-SAEs and SAEs were presented for all randomized participants excluding one randomized participant who withdrew consent and never received study treatment in "Tiotropium 18 mcg" arm. Adverse events were presented treatment-wise.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.25%
1/400 • Number of events 1 • Non-SAEs and SAEs were reported from start of study treatment and up to 95 days
Non-SAEs and SAEs were presented for all randomized participants excluding one randomized participant who withdrew consent and never received study treatment in "Tiotropium 18 mcg" arm. Adverse events were presented treatment-wise.
|
0.00%
0/399 • Non-SAEs and SAEs were reported from start of study treatment and up to 95 days
Non-SAEs and SAEs were presented for all randomized participants excluding one randomized participant who withdrew consent and never received study treatment in "Tiotropium 18 mcg" arm. Adverse events were presented treatment-wise.
|
|
Infections and infestations
Pneumonia
|
0.25%
1/400 • Number of events 1 • Non-SAEs and SAEs were reported from start of study treatment and up to 95 days
Non-SAEs and SAEs were presented for all randomized participants excluding one randomized participant who withdrew consent and never received study treatment in "Tiotropium 18 mcg" arm. Adverse events were presented treatment-wise.
|
0.75%
3/399 • Number of events 3 • Non-SAEs and SAEs were reported from start of study treatment and up to 95 days
Non-SAEs and SAEs were presented for all randomized participants excluding one randomized participant who withdrew consent and never received study treatment in "Tiotropium 18 mcg" arm. Adverse events were presented treatment-wise.
|
|
Infections and infestations
Postoperative wound infection
|
0.25%
1/400 • Number of events 1 • Non-SAEs and SAEs were reported from start of study treatment and up to 95 days
Non-SAEs and SAEs were presented for all randomized participants excluding one randomized participant who withdrew consent and never received study treatment in "Tiotropium 18 mcg" arm. Adverse events were presented treatment-wise.
|
0.00%
0/399 • Non-SAEs and SAEs were reported from start of study treatment and up to 95 days
Non-SAEs and SAEs were presented for all randomized participants excluding one randomized participant who withdrew consent and never received study treatment in "Tiotropium 18 mcg" arm. Adverse events were presented treatment-wise.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/400 • Non-SAEs and SAEs were reported from start of study treatment and up to 95 days
Non-SAEs and SAEs were presented for all randomized participants excluding one randomized participant who withdrew consent and never received study treatment in "Tiotropium 18 mcg" arm. Adverse events were presented treatment-wise.
|
0.25%
1/399 • Number of events 1 • Non-SAEs and SAEs were reported from start of study treatment and up to 95 days
Non-SAEs and SAEs were presented for all randomized participants excluding one randomized participant who withdrew consent and never received study treatment in "Tiotropium 18 mcg" arm. Adverse events were presented treatment-wise.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.25%
1/400 • Number of events 1 • Non-SAEs and SAEs were reported from start of study treatment and up to 95 days
Non-SAEs and SAEs were presented for all randomized participants excluding one randomized participant who withdrew consent and never received study treatment in "Tiotropium 18 mcg" arm. Adverse events were presented treatment-wise.
|
0.00%
0/399 • Non-SAEs and SAEs were reported from start of study treatment and up to 95 days
Non-SAEs and SAEs were presented for all randomized participants excluding one randomized participant who withdrew consent and never received study treatment in "Tiotropium 18 mcg" arm. Adverse events were presented treatment-wise.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.25%
1/400 • Number of events 1 • Non-SAEs and SAEs were reported from start of study treatment and up to 95 days
Non-SAEs and SAEs were presented for all randomized participants excluding one randomized participant who withdrew consent and never received study treatment in "Tiotropium 18 mcg" arm. Adverse events were presented treatment-wise.
|
0.00%
0/399 • Non-SAEs and SAEs were reported from start of study treatment and up to 95 days
Non-SAEs and SAEs were presented for all randomized participants excluding one randomized participant who withdrew consent and never received study treatment in "Tiotropium 18 mcg" arm. Adverse events were presented treatment-wise.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/400 • Non-SAEs and SAEs were reported from start of study treatment and up to 95 days
Non-SAEs and SAEs were presented for all randomized participants excluding one randomized participant who withdrew consent and never received study treatment in "Tiotropium 18 mcg" arm. Adverse events were presented treatment-wise.
|
0.25%
1/399 • Number of events 1 • Non-SAEs and SAEs were reported from start of study treatment and up to 95 days
Non-SAEs and SAEs were presented for all randomized participants excluding one randomized participant who withdrew consent and never received study treatment in "Tiotropium 18 mcg" arm. Adverse events were presented treatment-wise.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/400 • Non-SAEs and SAEs were reported from start of study treatment and up to 95 days
Non-SAEs and SAEs were presented for all randomized participants excluding one randomized participant who withdrew consent and never received study treatment in "Tiotropium 18 mcg" arm. Adverse events were presented treatment-wise.
|
0.25%
1/399 • Number of events 1 • Non-SAEs and SAEs were reported from start of study treatment and up to 95 days
Non-SAEs and SAEs were presented for all randomized participants excluding one randomized participant who withdrew consent and never received study treatment in "Tiotropium 18 mcg" arm. Adverse events were presented treatment-wise.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.25%
1/400 • Number of events 1 • Non-SAEs and SAEs were reported from start of study treatment and up to 95 days
Non-SAEs and SAEs were presented for all randomized participants excluding one randomized participant who withdrew consent and never received study treatment in "Tiotropium 18 mcg" arm. Adverse events were presented treatment-wise.
|
0.25%
1/399 • Number of events 1 • Non-SAEs and SAEs were reported from start of study treatment and up to 95 days
Non-SAEs and SAEs were presented for all randomized participants excluding one randomized participant who withdrew consent and never received study treatment in "Tiotropium 18 mcg" arm. Adverse events were presented treatment-wise.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.2%
5/400 • Number of events 6 • Non-SAEs and SAEs were reported from start of study treatment and up to 95 days
Non-SAEs and SAEs were presented for all randomized participants excluding one randomized participant who withdrew consent and never received study treatment in "Tiotropium 18 mcg" arm. Adverse events were presented treatment-wise.
|
0.75%
3/399 • Number of events 3 • Non-SAEs and SAEs were reported from start of study treatment and up to 95 days
Non-SAEs and SAEs were presented for all randomized participants excluding one randomized participant who withdrew consent and never received study treatment in "Tiotropium 18 mcg" arm. Adverse events were presented treatment-wise.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.25%
1/400 • Number of events 1 • Non-SAEs and SAEs were reported from start of study treatment and up to 95 days
Non-SAEs and SAEs were presented for all randomized participants excluding one randomized participant who withdrew consent and never received study treatment in "Tiotropium 18 mcg" arm. Adverse events were presented treatment-wise.
|
0.00%
0/399 • Non-SAEs and SAEs were reported from start of study treatment and up to 95 days
Non-SAEs and SAEs were presented for all randomized participants excluding one randomized participant who withdrew consent and never received study treatment in "Tiotropium 18 mcg" arm. Adverse events were presented treatment-wise.
|
Other adverse events
| Measure |
Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25 mcg
n=400 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 tiotropium (TIO) via HandiHaler (once daily in the morning) for 84 days. Participants received albuterol/salbutamol as rescue medication via metered dose inhaler (MDI) during conduct of the study, if required.
|
Tiotropium 18 mcg
n=399 participants at risk
Participants received 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 via MDI during conduct of the study, if required.
|
|---|---|---|
|
Nervous system disorders
Headache
|
4.5%
18/400 • Number of events 30 • Non-SAEs and SAEs were reported from start of study treatment and up to 95 days
Non-SAEs and SAEs were presented for all randomized participants excluding one randomized participant who withdrew consent and never received study treatment in "Tiotropium 18 mcg" arm. Adverse events were presented treatment-wise.
|
5.5%
22/399 • Number of events 69 • Non-SAEs and SAEs were reported from start of study treatment and up to 95 days
Non-SAEs and SAEs were presented for all randomized participants excluding one randomized participant who withdrew consent and never received study treatment in "Tiotropium 18 mcg" arm. Adverse events were presented treatment-wise.
|
|
Infections and infestations
Nasopharyngitis
|
4.0%
16/400 • Number of events 17 • Non-SAEs and SAEs were reported from start of study treatment and up to 95 days
Non-SAEs and SAEs were presented for all randomized participants excluding one randomized participant who withdrew consent and never received study treatment in "Tiotropium 18 mcg" arm. Adverse events were presented treatment-wise.
|
2.0%
8/399 • Number of events 8 • Non-SAEs and SAEs were reported from start of study treatment and up to 95 days
Non-SAEs and SAEs were presented for all randomized participants excluding one randomized participant who withdrew consent and never received study treatment in "Tiotropium 18 mcg" arm. 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