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Clinical Trial Results:
DB2114930: A randomized, multi-center, double-blind, doubledummy, parallel group study to evaluate the efficacy and safety of umeclidinium/vilanterol compared with fluticasone propionate/salmeterol over 12 weeks in subjects with COPD.

Summary
EudraCT number	2012-000525-45
Trial protocol	GR
Global end of trial date	25 Oct 2013

Results information
Results version number	v1(current)
This version publication date	27 Apr 2016
First version publication date	01 May 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

DB2114930

ISRCTN number

-

US NCT number

NCT01817764

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)

No

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

No

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

No

Analysis stage

Final

Date of interim/final analysis

14 Jan 2014

Is this the analysis of the primary completion data?

No

Global end of trial reached?

Yes

Global end of trial date

25 Oct 2013

Was the trial ended prematurely?

No

Main objective of the trial

Compare the efficacy and safety of UMEC/VI Inhalation Powder (62.5/25mcg oncedaily) with fluticasone propionate/salmeterol (250/50mcg twice-daily) over 12 weeks in subjects with COPD who have a history of infrequent COPD exacerbations

Protection of trial subjects

Several measures were taken to protect trials subjects: these included adverse event monitoring throughout the study, frequent clinic visits (approximately every 4 weeks) to monitor subject status, exclusion of patients with clinically significant and uncontrolled medical conditions and/or ECG findings, and use of treatment arms where all patients received pharmacologic treatment that was appropriate for the disease and disease severity under study. Fluticasone propionate/salmeterol combination inhalation powder is a marketed product and was administered according to the local label. Fluticasone propionate/salmeterol has an acceptable safety profile for use. This conclusion is supported by the results of previously performed clinical studies and post-marketing experience (see local label). All patients were on active treatment.

Background therapy

-

Evidence for comparator

-

Actual start date of recruitment

26 Mar 2013

Long term follow-up planned

No

Independent data monitoring committee (IDMC) involvement?

No

Number of subjects enrolled per country

Country: Number of subjects enrolled

Argentina: 126

Country: Number of subjects enrolled

Chile: 124

Country: Number of subjects enrolled

Greece: 69

Country: Number of subjects enrolled

Peru: 16

Country: Number of subjects enrolled

Romania: 192

Country: Number of subjects enrolled

Ukraine: 210

Country: Number of subjects enrolled

United States: 184

Worldwide total number of subjects

921

EEA total number of subjects

261

Number of subjects enrolled per age group

In utero

0

Preterm newborn - gestational age < 37 wk

0

Newborns (0-27 days)

0

Infants and toddlers (28 days-23 months)

0

Children (2-11 years)

0

Adolescents (12-17 years)

0

Adults (18-64 years)

531

From 65 to 84 years

385

85 years and over

5

Subject disposition

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Recruitment details

-

Screening details

A total of 707 participants, representing the enrolled participants, were randomized to study treatment. Of these, 706 comprised the Intent-to-Treat 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

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

Are arms mutually exclusive

Yes

Umeclidinium bromide/vilanterol 62.5/25 mcg

Arm description

Participants were randomized to umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once-daily (QD) treatment in the morning via a dry powder inhaler (DPI) and placebo in the morning and evening via a separate DPI.

Arm type

Experimental

Investigational medicinal product name

Umeclidinium bromide/ vilanterol

Investigational medicinal product code

Other name

Pharmaceutical forms

Inhalation powder

Routes of administration

Respiratory use

Dosage and administration details

62.5/25 mcg once-daily via dry powder inhaler

Fluticasone propionate/salmeterol 250/50 mcg

Arm description

Participants were randomized to fluticasone propionate/salmeterol (FSC) 250/50 µg twice-daily (BID) treatment in the morning and evening via a DPI and placebo in the morning via a separate DPI.

Arm type

Active comparator

Investigational medicinal product name

fluticasone propionate/salmeterol

Investigational medicinal product code

Other name

Pharmaceutical forms

Inhalation powder

Routes of administration

Respiratory use

Dosage and administration details

250/50 mcg twice-daily via dry powder inhaler

Number of subjects in period 1 ^[1]	Umeclidinium bromide/vilanterol 62.5/25 mcg	Fluticasone propionate/salmeterol 250/50 mcg
Started	353	353
Completed	319	315
Not completed	34	38
Consent withdrawn by subject	10	12
Adverse event, non-fatal	7	10
Lost to follow-up	1	4
Lack of efficacy	9	7
Protocol deviation	7	5

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: Although 921 participants were enrolled in the trial worldwide, only 707 were randomized to treatment. Of these, 706 participants comprised the Intent-to-Treat Population (participants randomized to treatment who received >=1 dose of randomized study medication in the treatment period).

Baseline characteristics

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Reporting group title

Umeclidinium bromide/vilanterol 62.5/25 mcg

Reporting group description

Participants were randomized to umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once-daily (QD) treatment in the morning via a dry powder inhaler (DPI) and placebo in the morning and evening via a separate DPI.

Reporting group title

Fluticasone propionate/salmeterol 250/50 mcg

Reporting group description

Participants were randomized to fluticasone propionate/salmeterol (FSC) 250/50 µg twice-daily (BID) treatment in the morning and evening via a DPI and placebo in the morning via a separate DPI.

Reporting group values	Umeclidinium bromide/vilanterol 62.5/25 mcg	Fluticasone propionate/salmeterol 250/50 mcg	Total
Number of subjects	353	353	706
Age categorical
Units: Subjects
Age continuous
Units: years
arithmetic mean (standard deviation)	62.5 ( 9.05 )	63 ( 8.91 )	-
Gender categorical
Units: Subjects
Female	100	109	209
Male	253	244	497
Race
Units: Subjects
African American/African Heritage	4	3	7
American Indian or Alaska Native	5	5	10
Asian - East Asian Heritage	1	1	2
Asian - Japanese Heritage	2	1	3
White - Arabic/North African Heritage	0	1	1
White - White/Caucasian/European	341	342	683

End points

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Reporting group title

Umeclidinium bromide/vilanterol 62.5/25 mcg

Reporting group description

Participants were randomized to umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once-daily (QD) treatment in the morning via a dry powder inhaler (DPI) and placebo in the morning and evening via a separate DPI.

Reporting group title

Fluticasone propionate/salmeterol 250/50 mcg

Reporting group description

Participants were randomized to fluticasone propionate/salmeterol (FSC) 250/50 µg twice-daily (BID) treatment in the morning and evening via a DPI and placebo in the morning via a separate DPI.

Primary: Change from Baseline in 24-hour weighted-mean serial FEV1 on Treatment Day 84

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End point title

Change from Baseline in 24-hour weighted-mean serial FEV1 on Treatment 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. Weighted mean is calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5 and 15 minutes and 1, 3, 6, 9, 12 (pre-evening dose), 13, 15, 18, 23, and 24 hours after the morning dose. Change from Baseline was calculated as the value at Day 84 minus the value at Baseline. Analysis was performed using an analysis of covariance of treatment, Baseline (mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1), and smoking status. par.=participants.

End point type

Primary

End point timeframe

Baseline and Day 84

End point values	Umeclidinium bromide/vilanterol 62.5/25 mcg	Fluticasone propionate/salmeterol 250/50 mcg
Number of subjects analysed	315 ^[1]	310 ^[2]
Units: Liters
least squares mean (standard error)	0.165 ( 0.013 )	0.091 ( 0.0131 )

Notes
[1] - Intent-to-Treat (ITT) Population
[2] - Intent-to-Treat (ITT) Population

Analysis 1

Comparison groups

Umeclidinium bromide/vilanterol 62.5/25 mcg v Fluticasone propionate/salmeterol 250/50 mcg

Number of subjects included in analysis

625

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Parameter type

Mean difference (net)

Point estimate

0.074

Confidence interval

level

95%

sides

2-sided

lower limit

0.038

upper limit

0.11

Secondary: Change from Baseline in trough FEV1 on Day 85

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End point title

Change from Baseline in trough FEV1 on 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. BL is defined as the mean of the assessments made 30 and 5 min pre-dose on treatment (trt) Day 1. Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after morning dosing on Day 84. Analysis was performed using a repeated measures model with covariates of trt, BL (mean of the 2 assessments made 30 and 5 min pre-dose on Day 1), smoking status, day, day by BL and day by trt interactions. The model used all available trough FEV1 values recorded on Days 28, 56, 84, and 85. Missing data were not directly imputed in this analysis; however, all non-missing data for a par. were used to estimate the trt effect for trough FEV1 at Day 85. Change from BL=value at Day 84 minus value at BL. Par. analyzed were those with data available at the time point; but, all par. without missing covariate information were included in the analysis.

End point type

Secondary

End point timeframe

Baseline and Day 85

End point values	Umeclidinium bromide/vilanterol 62.5/25 mcg	Fluticasone propionate/salmeterol 250/50 mcg
Number of subjects analysed	317 ^[3]	312 ^[4]
Units: Liters
least squares mean (standard error)	0.154 ( 0.0133 )	0.072 ( 0.0134 )

Notes
[3] - Intent-to-Treat (ITT) Population
[4] - Intent-to-Treat (ITT) Population

Analysis 2

Comparison groups

Umeclidinium bromide/vilanterol 62.5/25 mcg v Fluticasone propionate/salmeterol 250/50 mcg

Number of subjects included in analysis

629

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Repeated measures

Confidence interval

level

95%

sides

2-sided

lower limit

0.045

upper limit

0.119

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 the start of study medication until the follow-up contact (up to 13 weeks).

Adverse event reporting additional description

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

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

16.1

Reporting group title

Umeclidinium bromide/vilanterol 62.5/25 mcg

Reporting group description

Participants were randomized to umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once-daily (QD) treatment in the morning via a dry powder inhaler (DPI) and placebo in the morning and evening via a separate DPI.

Reporting group title

Fluticasone propionate/salmeterol 250/50 mcg

Reporting group description

Participants were randomized to fluticasone propionate/salmeterol (FSC) 250/50 µg twice-daily (BID) treatment in the morning and evening via a DPI and placebo in the morning via a separate DPI.

Serious adverse events	Umeclidinium bromide/vilanterol 62.5/25 mcg	Fluticasone propionate/salmeterol 250/50 mcg
Total subjects affected by serious adverse events
subjects affected / exposed	6 / 353 (1.70%)	10 / 353 (2.83%)
number of deaths (all causes)	0	3
number of deaths resulting from adverse events	0	0
Investigations
Alanine aminotransferase increased
subjects affected / exposed	0 / 353 (0.00%)	1 / 353 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
subjects affected / exposed	0 / 353 (0.00%)	1 / 353 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ovarian cancer
subjects affected / exposed	1 / 353 (0.28%)	0 / 353 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
Head injury
subjects affected / exposed	1 / 353 (0.28%)	0 / 353 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Subdural haematoma
subjects affected / exposed	1 / 353 (0.28%)	0 / 353 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thermal burn
subjects affected / exposed	0 / 353 (0.00%)	1 / 353 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
Myocardial infarction
subjects affected / exposed	0 / 353 (0.00%)	1 / 353 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Nervous system disorders
Ischaemic stroke
subjects affected / exposed	0 / 353 (0.00%)	2 / 353 (0.57%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
subjects affected / exposed	1 / 353 (0.28%)	0 / 353 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
subjects affected / exposed	1 / 353 (0.28%)	0 / 353 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary embolism
subjects affected / exposed	0 / 353 (0.00%)	1 / 353 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Chronic obstructive pulmonary disease
subjects affected / exposed	1 / 353 (0.28%)	3 / 353 (0.85%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Bronchitis
subjects affected / exposed	0 / 353 (0.00%)	1 / 353 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Burn infection
subjects affected / exposed	0 / 353 (0.00%)	1 / 353 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis viral
subjects affected / exposed	1 / 353 (0.28%)	0 / 353 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infective exacerbation of chronic obstructive airways disease
subjects affected / exposed	0 / 353 (0.00%)	1 / 353 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	0 / 353 (0.00%)	3 / 353 (0.85%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1

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

Non-serious adverse events	Umeclidinium bromide/vilanterol 62.5/25 mcg	Fluticasone propionate/salmeterol 250/50 mcg
Total subjects affected by non serious adverse events
subjects affected / exposed	38 / 353 (10.76%)	25 / 353 (7.08%)
Nervous system disorders
Headache
subjects affected / exposed	23 / 353 (6.52%)	17 / 353 (4.82%)
occurrences all number	36	29
Infections and infestations
Nasopharyngitis
subjects affected / exposed	16 / 353 (4.53%)	8 / 353 (2.27%)
occurrences all number	18	9

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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