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Clinical Trial Results:
A study to compare the addition of umeclidinium bromide (UMEC) to fluticasone furoate (FF)/vilanterol (VI), with placebo plus FF/VI in subjects with Chronic Obstructive Pulmonary Disease (COPD) -Study 1

Summary
EudraCT number	2013-002238-19
Trial protocol	RO
Global end of trial date	01 Apr 2014

Results information
Results version number	v1(current)
This version publication date	02 May 2016
First version publication date	21 Jun 2015
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

200109

ISRCTN number

US NCT number

NCT01957163

WHO universal trial number (UTN)

Sponsor organisation name

GlaxoSmithKline

Sponsor organisation address

980 Great West Road, Brentford, Middlesex, United Kingdom,

Public contact

GSK Response Center, GlaxoSmithKline, 1 866-435-7343,

Scientific contact

GSK Response Center, GlaxoSmithKline, 1 866-435-7343,

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

27 May 2014

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

01 Apr 2014

Was the trial ended prematurely?

Main objective of the trial

The primary objective is to evaluate the efficacy and safety of the addition of UMEC 125 mcg to FF/VI 100/25 mcg once-daily and the addition of UMEC 62.5 mcg to FF/VI 100/25 mcg once-daily, compared with placebo plus FF/VI 100/25 once-daily over 12 weeks in subjects with COPD.

Protection of trial subjects

Spirometry procedures may cause difficulty breathing, changes in pulse rate/blood pressure, coughing, wheezing, chest tightness, or fainting. Subjects (sub.) will be monitored during the procedure for these effects, and spirometry will be discontinued if this occurs. Skin irritation is rare but could occur during ECG from the electrodes. It may be necessary to shave small patches of hair to properly attach electrodes. Sub. will be monitored during the procedure for these effects and should call their study doctor if effects do not resolve. Side effects of albuterol/salbutamol include shakiness, headache, sleeplessness, high blood pressure, heart beating fast/irregular beats, cough, wheezing, shortness of breath, increased fluid in the mouth, nausea, upset stomach, tiredness, anxiety/nervousness, or low blood potassium. Sub. should call their study doctor if they experience any of these symptoms. Sub. with poorly controlled COPD/experience an exacerbation of COPD during the run-in period will not be randomized. ICS/LABA combination therapy is associated with an increased risk of pneumonia but no other significant side effects in COPD. Sub. with a lower respiratory tract infection that required the use of antibiotics within 6 weeks prior to Visit 1 are excluded from the study in order to ensure patient safety. LABAs may increase the risk of asthma-related death. Sub. with a current diagnosis of asthma will be excluded from study participation. Cardiovascular effects such as cardiac arrhythmias, e.g., supraventricular tachycardia and extrasystoles, are also class effects associated with LABAs and LABA-containing therapy. Exclusion criteria have been set for sub. with uncontrolled or severe cardiovascular disease according to the PI’s opinion where the potential risk may outweigh the benefit. The Investigator should also determine the clinical significance of abnormal ECG findings at screening and exclude sub. who would be at undue risk by participating in the trial.

Background therapy

Evidence for comparator

Actual start date of recruitment

04 Oct 2013

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Romania: 117

Country: Number of subjects enrolled

United States: 197

Country: Number of subjects enrolled

Chile: 150

Country: Number of subjects enrolled

Canada: 150

Country: Number of subjects enrolled

Argentina: 113

Worldwide total number of subjects

727

EEA total number of subjects

117

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

369

From 65 to 84 years

355

85 years and over

Subject disposition

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Recruitment details

Participants ≥ 40 years of age with history of chronic obstructive pulmonary disease (COPD) and a smoking history of ≥ 10 pack-years were enrolled in the study. Participants completed a 4-week run-in period, in which they received fluticasone furoate 100 micrograms(µg)/vilanterol 25 µg, followed by a 12-week treatment period and 1-week follow-up.

Screening details

A total of 619 participants (pars.) were randomized to study treatment and comprised the Intent-to-Treat (ITT) Population (participants randomized to treatment who received ≥ 1 dose of randomized study medication in the treatment period).

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Investigator, Monitor, Data analyst, Carer, Assessor, Subject

Are arms mutually exclusive

Yes

Fluticasone furoate/vilanterol 100/25 μg + placebo

Arm description

Participants received one inhalation of fluticasone furoate (FF)/vilanterol (VI) 100/25 µg once-daily (OD) via a dry powder inhaler (DPI), followed by one inhalation of umeclidinium bromide (UMEC) matching placebo, administered via a dry powder inhaler in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Inhalation powder

Routes of administration

Inhalation use

Dosage and administration details

Matching placebo

Investigational medicinal product name

Fluticasone furoate/vilanterol

Investigational medicinal product code

Other name

Pharmaceutical forms

Inhalation powder

Routes of administration

Inhalation use

Dosage and administration details

Fluticasone furoate/vilanterol 100/25 µg once daily

Fluticasone furoate/vilanterol 100/25 μg + UMEC 62.5 µg

Arm description

Participants received one inhalation of fluticasone furoate (FF)/vilanterol (VI) 100/25 µg once- daily via a dry powder inhaler followed by one inhalation of umeclidinium bromide (UMEC) 62.5 µg administered via a dry powder inhaler in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.

Arm type

Experimental

Investigational medicinal product name

UMEC

Investigational medicinal product code

Other name

Pharmaceutical forms

Inhalation powder

Routes of administration

Inhalation use

Dosage and administration details

62.5 µg once daily

Investigational medicinal product name

Fluticasone furoate/vilanterol

Investigational medicinal product code

Other name

Pharmaceutical forms

Inhalation powder

Routes of administration

Inhalation use

Dosage and administration details

Fluticasone furoate/vilanterol 100/25 µg once daily

Fluticasone furoate/vilanterol 100/25 μg + UMEC 125 μg

Arm description

Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhaler followed by one inhalation of umeclidinium bromide 125 µg administered via a dry powder inhaler in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.

Arm type

Experimental

Investigational medicinal product name

UMEC

Investigational medicinal product code

Other name

Pharmaceutical forms

Inhalation powder

Routes of administration

Inhalation use

Dosage and administration details

125 µg once daily

Investigational medicinal product name

Fluticasone furoate/vilanterol

Investigational medicinal product code

Other name

Pharmaceutical forms

Inhalation powder

Routes of administration

Inhalation use

Dosage and administration details

Fluticasone furoate/vilanterol 100/25 µg once daily

Number of subjects in period 1 ^[1]	Fluticasone furoate/vilanterol 100/25 μg + placebo	Fluticasone furoate/vilanterol 100/25 μg + UMEC 62.5 µg	Fluticasone furoate/vilanterol 100/25 μg + UMEC 125 μg
Started	206	206	207
Completed	191	195	189
Not completed	15	11	18
Adverse event, serious fatal	1	-	-
Consent withdrawn by subject	4	2	4
Adverse event, non-fatal	4	2	4
Met Protocol-Defined Stopping Criteria	-	-	1
Lost to follow-up	-	1	-
Lack of efficacy	5	4	9
Protocol deviation	1	2	-

Notes
[1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: The baseline period includes only those enrolled participants who were randomized to treatment and received >=1 dose of randomized study medication in the Treatment Period (n=619).

Baseline characteristics

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Reporting group title

Fluticasone furoate/vilanterol 100/25 μg + placebo

Reporting group description

Reporting group title

Fluticasone furoate/vilanterol 100/25 μg + UMEC 62.5 µg

Reporting group description

Reporting group title

Fluticasone furoate/vilanterol 100/25 μg + UMEC 125 μg

Reporting group description

Reporting group values	Fluticasone furoate/vilanterol 100/25 μg + placebo	Fluticasone furoate/vilanterol 100/25 μg + UMEC 62.5 µg	Fluticasone furoate/vilanterol 100/25 μg + UMEC 125 μg	Total
Number of subjects	206	206	207	619
Age categorical
Units: Subjects
Age continuous
Units: years
arithmetic mean (standard deviation)	64.7 ( 7.9 )	64.9 ( 8.72 )	63.8 ( 7.65 )	-
Gender categorical
Units: Subjects
Female	65	67	80	212
Male	141	139	127	407
Race, Customized
Units: Subjects
African American/African Heritage	5	4	5	14
American Indian or Alaska Native	1	0	0	1
White - Arabic/North African Heritage	0	1	0	1
White - White/Caucasian/European Heritage	200	201	202	603

End points

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Reporting group title

Fluticasone furoate/vilanterol 100/25 μg + placebo

Reporting group description

Reporting group title

Fluticasone furoate/vilanterol 100/25 μg + UMEC 62.5 µg

Reporting group description

Reporting group title

Fluticasone furoate/vilanterol 100/25 μg + UMEC 125 μg

Reporting group description

Primary: Change from Baseline (BL) in trough forced expiratory volume in one second (FEV1) at Day 85

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End point title

Change from Baseline (BL) in trough forced expiratory volume in one second (FEV1) at Day 85

End point description

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 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Day 84. Analysis was performed using a mixed model repeated measures (MMRM) with covariates of treatment, Baseline FEV1, smoking status, Day, treatment, Day by baseline interaction and Day by treatment interaction, Day being nominal. Baseline FEV1 is the mean of the two assessments made at 30 and 5 minutes (min) pre-dose on Day 1. The change from baseline value is the difference between the on-treatment value and the baseline value. The number of participants presented represent those with data available at the time point being presented; however, all participants in the Intent-to-Treat (ITT) Population without missing covariate information and with at least one post baseline measurement are included in the analysis.

End point type

Primary

End point timeframe

Day 85

End point values	Fluticasone furoate/vilanterol 100/25 μg + placebo	Fluticasone furoate/vilanterol 100/25 μg + UMEC 62.5 µg	Fluticasone furoate/vilanterol 100/25 μg + UMEC 125 μg
Number of subjects analysed	190 ^[1]	195 ^[2]	188 ^[3]
Units: Liters
least squares mean (standard error)	-0.02 ( 0.0111 )	0.103 ( 0.011 )	0.108 ( 0.0111 )

Notes
[1] - Note: 205 subjects had analyzable data for one or more timepoints.
[2] - Note: 206 subjects had analyzable data for one or more timepoints.
[3] - Note: 206 subjects had analyzable data for one or more timepoints.

Statistical Analysis 1

Comparison groups

Fluticasone furoate/vilanterol 100/25 μg + placebo v Fluticasone furoate/vilanterol 100/25 μg + UMEC 62.5 µg

Number of subjects included in analysis

385

Analysis specification

Pre-specified

Analysis type

superiority ^[4]

P-value

< 0.001 ^[5]

Method

Mixed Model Repeated Measure

Parameter type

Least squared mean difference

Point estimate

0.124

Confidence interval

level

95%

sides

2-sided

lower limit

0.093

upper limit

0.154

Notes
[4] - The data presented in this table is showing the comparison of Fluticasone furoate/vilanterol 100/25 μg + UMEC 62.5 μg v Fluticasone furoate/vilanterol 100/25 μg + placebo
[5] - Restricted maximum likelihood (REM) – based repeated measure approach (MMRM)

Statistical Analysis 2

Comparison groups

Fluticasone furoate/vilanterol 100/25 μg + placebo v Fluticasone furoate/vilanterol 100/25 μg + UMEC 125 μg

Number of subjects included in analysis

378

Analysis specification

Pre-specified

Analysis type

superiority ^[6]

P-value

< 0.001 ^[7]

Method

Mixed Model Repeated Measure

Parameter type

Least squared mean difference

Point estimate

0.128

Confidence interval

level

95%

sides

2-sided

lower limit

0.098

upper limit

0.159

Notes
[6] - The data presented in this table is showing the comparison of Fluticasone furoate/vilanterol 100/25 μg + UMEC 125 μg v Fluticasone furoate/vilanterol 100/25 μg + placebo
[7] - Restricted maximum likelihood (REM) – based repeated measure approach (MMRM)

Secondary: Change from Baseline in 0-6 hour weighted mean (WM) FEV1 obtained post-dose at Day 84

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End point title

Change from Baseline in 0-6 hour weighted mean (WM) FEV1 obtained post-dose at Day 84

End point description

FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The 0-6 hour weighted mean was derived by calculating the area under the FEV1/time curve over the nominal time points of 0 hour (trough value), 15 and 30 min, 1, 3 and 6 hours, using the trapezoidal rule, and then dividing by the actual time between dosing and the 6 hour assessment. Analysis was performed using MMRM with covariates of treatment, Baseline FEV1 (mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1), smoking status, Day, and Day by Baseline and Day by treatment interactions. Baseline FEV1 is the mean of the two assessments made at 30 and 5 min pre-dose on Day 1. The change from baseline value is the difference between the on-treatment value and the baseline value. All participants in the ITT Population without missing covariate information and with at least one post baseline measurement are included in the analysis.

End point type

Secondary

End point timeframe

Day 84

End point values	Fluticasone furoate/vilanterol 100/25 μg + placebo	Fluticasone furoate/vilanterol 100/25 μg + UMEC 62.5 µg	Fluticasone furoate/vilanterol 100/25 μg + UMEC 125 μg
Number of subjects analysed	191 ^[8]	195 ^[9]	189 ^[10]
Units: Liters
least squares mean (standard error)	0.034 ( 0.0123 )	0.187 ( 0.0122 )	0.175 ( 0.0123 )

Notes
[8] - Note: 205 subjects had analyzable data for one or more timepoints.
[9] - Note: 206 subjects had analyzable data for one or more timepoints.
[10] - Note: 206 subjects had analyzable data for one or more timepoints.

Statistical Analysis 1

Comparison groups

Fluticasone furoate/vilanterol 100/25 μg + placebo v Fluticasone furoate/vilanterol 100/25 μg + UMEC 62.5 µg

Number of subjects included in analysis

386

Analysis specification

Pre-specified

Analysis type

superiority ^[11]

P-value

< 0.001 ^[12]

Method

Mixed Model Repeated Measure

Parameter type

Least squared mean difference

Point estimate

0.153

Confidence interval

level

95%

sides

2-sided

lower limit

0.118

upper limit

0.187

Notes
[11] - The data presented in this table is showing the comparison of Fluticasone furoate/vilanterol 100/25 μg + UMEC 62.5 μg v Fluticasone furoate/vilanterol 100/25 μg + placebo
[12] - Restricted maximum likelihood (REM) – based repeated measure approach (MMRM)

Statistical Analysis 2

Comparison groups

Fluticasone furoate/vilanterol 100/25 μg + placebo v Fluticasone furoate/vilanterol 100/25 μg + UMEC 125 μg

Number of subjects included in analysis

380

Analysis specification

Pre-specified

Analysis type

superiority ^[13]

P-value

< 0.001 ^[14]

Method

Mixed Model Repeated Measure

Parameter type

Least squared mean difference

Point estimate

0.14

Confidence interval

level

95%

sides

2-sided

lower limit

0.106

upper limit

0.175

Notes
[13] - The data presented in this table is showing the comparison of Fluticasone furoate/vilanterol 100/25 μg + UMEC 125 μg v Fluticasone furoate/vilanterol 100/25 μg + placebo
[14] - Restricted maximum likelihood (REM) – based repeated measure approach (MMRM)

Adverse events

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Timeframe for reporting adverse events

On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study medication until follow-up visit (up to 14 weeks).

Adverse event reporting additional description

On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

16.1

Reporting group title

Fluticasone furoate/vilanterol 100/25 μg + placebo

Reporting group description

Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once-daily (OD) via a dry powder inhaler (DPI), followed by one inhalation of umeclidinium bromide (UMEC) matching placebo, administered via a dry powder inhaler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.

Reporting group title

Fluticasone furoate/vilanterol 100/25 μg + UMEC 62.5 μg

Reporting group description

Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhaler followed by one inhalation of umeclidinium bromide 62.5 µg administered via a dry powder inhaler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.

Reporting group title

Fluticasone furoate/vilanterol 100/25 μg + UMEC 125 μg

Reporting group description

Serious adverse events	Fluticasone furoate/vilanterol 100/25 μg + placebo	Fluticasone furoate/vilanterol 100/25 μg + UMEC 62.5 μg	Fluticasone furoate/vilanterol 100/25 μg + UMEC 125 μg
Total subjects affected by serious adverse events
subjects affected / exposed	6 / 206 (2.91%)	2 / 206 (0.97%)	7 / 207 (3.38%)
number of deaths (all causes)	1	0	0
number of deaths resulting from adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
subjects affected / exposed	0 / 206 (0.00%)	0 / 206 (0.00%)	1 / 207 (0.48%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lung neoplasm malignant
subjects affected / exposed	0 / 206 (0.00%)	1 / 206 (0.49%)	0 / 207 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Rectal cancer
subjects affected / exposed	1 / 206 (0.49%)	0 / 206 (0.00%)	0 / 207 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Shunt stenosis
subjects affected / exposed	1 / 206 (0.49%)	0 / 206 (0.00%)	0 / 207 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac disorders
Atrial fibrillation
subjects affected / exposed	0 / 206 (0.00%)	0 / 206 (0.00%)	1 / 207 (0.48%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac failure congestive
subjects affected / exposed	0 / 206 (0.00%)	0 / 206 (0.00%)	1 / 207 (0.48%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardio-respiratory arrest
subjects affected / exposed	1 / 206 (0.49%)	0 / 206 (0.00%)	0 / 207 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0
Myocardial infarction
subjects affected / exposed	1 / 206 (0.49%)	0 / 206 (0.00%)	0 / 207 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nervous system disorders
Grand mal convulsion
subjects affected / exposed	0 / 206 (0.00%)	1 / 206 (0.49%)	0 / 207 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Pancreatitis acute
subjects affected / exposed	0 / 206 (0.00%)	0 / 206 (0.00%)	1 / 207 (0.48%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Hepatic congestion
subjects affected / exposed	0 / 206 (0.00%)	0 / 206 (0.00%)	1 / 207 (0.48%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary
subjects affected / exposed	1 / 206 (0.49%)	0 / 206 (0.00%)	4 / 207 (1.93%)
occurrences causally related to treatment / all	0 / 1	0 / 0	1 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infections and infestations
Influenza
subjects affected / exposed	0 / 206 (0.00%)	0 / 206 (0.00%)	1 / 207 (0.48%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Klebsiella sepsis
subjects affected / exposed	0 / 206 (0.00%)	0 / 206 (0.00%)	1 / 207 (0.48%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	2 / 206 (0.97%)	0 / 206 (0.00%)	0 / 207 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 3%

Non-serious adverse events	Fluticasone furoate/vilanterol 100/25 μg + placebo	Fluticasone furoate/vilanterol 100/25 μg + UMEC 62.5 μg	Fluticasone furoate/vilanterol 100/25 μg + UMEC 125 μg
Total subjects affected by non serious adverse events
subjects affected / exposed	15 / 206 (7.28%)	26 / 206 (12.62%)	26 / 207 (12.56%)
Nervous system disorders
Headache
subjects affected / exposed	6 / 206 (2.91%)	9 / 206 (4.37%)	9 / 207 (4.35%)
occurrences all number	8	11	10
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	1 / 206 (0.49%)	3 / 206 (1.46%)	7 / 207 (3.38%)
occurrences all number	1	3	7
Musculoskeletal and connective tissue disorders
Back pain
subjects affected / exposed	3 / 206 (1.46%)	7 / 206 (3.40%)	5 / 207 (2.42%)
occurrences all number	3	10	5
Infections and infestations
Nasopharyngitis
subjects affected / exposed	7 / 206 (3.40%)	7 / 206 (3.40%)	10 / 207 (4.83%)
occurrences all number	7	7	11

More information

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Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results:
A study to compare the addition of umeclidinium bromide (UMEC) to fluticasone furoate (FF)/vilanterol (VI), with placebo plus FF/VI in subjects with Chronic Obstructive Pulmonary Disease (COPD) -Study 1

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Change from Baseline (BL) in trough forced expiratory volume in one second (FEV1) at Day 85

Primary: Change from Baseline (BL) in trough forced expiratory volume in one second (FEV1) at Day 85

Secondary: Change from Baseline in 0-6 hour weighted mean (WM) FEV1 obtained post-dose at Day 84

Secondary: Change from Baseline in 0-6 hour weighted mean (WM) FEV1 obtained post-dose at Day 84

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

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Outside EU/EEA

Clinical trials

Clinical Trial Results: A study to compare the addition of umeclidinium bromide (UMEC) to fluticasone furoate (FF)/vilanterol (VI), with placebo plus FF/VI in subjects with Chronic Obstructive Pulmonary Disease (COPD) -Study 1

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Change from Baseline (BL) in trough forced expiratory volume in one second (FEV1) at Day 85

Primary: Change from Baseline (BL) in trough forced expiratory volume in one second (FEV1) at Day 85

Secondary: Change from Baseline in 0-6 hour weighted mean (WM) FEV1 obtained post-dose at Day 84

Secondary: Change from Baseline in 0-6 hour weighted mean (WM) FEV1 obtained post-dose at Day 84

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A study to compare the addition of umeclidinium bromide (UMEC) to fluticasone furoate (FF)/vilanterol (VI), with placebo plus FF/VI in subjects with Chronic Obstructive Pulmonary Disease (COPD) -Study 1