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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03034915




Registration number
NCT03034915
Ethics application status
Date submitted
25/01/2017
Date registered
27/01/2017
Date last updated
11/03/2020

Titles & IDs
Public title
A 24-week Study to Compare Umeclidinium/Vilanterol (UMEC/VI), UMEC and Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Scientific title
A 24-week Treatment, Multi-center, Randomized, Double-blind, Double-dummy, Parallel Group Study to Compare Umeclidinium/Vilanterol, Umeclidinium, and Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Secondary ID [1] 0 0
2016-002513-22
Secondary ID [2] 0 0
201749
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Disease, Chronic Obstructive 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - UMEC/VI 62.5/25 mcg via ELLIPTA
Treatment: Drugs - UMEC 62.5 mcg via ELLIPTA
Treatment: Drugs - Salmeterol 50 mcg via DISKUS
Treatment: Drugs - Placebo via ELLIPTA
Treatment: Drugs - Placebo via DISKUS

Experimental: UMEC/VI 62.5/25 mcg via ELLIPTA + placebo via DISKUS - Subjects will be instructed to self-administer one dose of UMEC/VI 62.5/25 mcg inhalation powder each morning via ELLIPTA DPI and placebo twice daily (morning and evening) via DISKUS DPI.

Experimental: UMEC 62.5 mcg via ELLIPTA + placebo via DISKUS - Subjects will be instructed to self-administer one dose of UMEC 62.5 mcg inhalation powder each morning via ELLIPTA DPI and placebo twice daily (morning and evening) via DISKUS DPI.

Experimental: Salmeterol 50 mcg via DISKUS + placebo via ELLIPTA - Subjects will be instructed to self-administer one dose of salmeterol 50 mcg twice daily (morning and evening) via DISKUS DPI and placebo once daily morning via ELLIPTA DPI.


Treatment: Drugs: UMEC/VI 62.5/25 mcg via ELLIPTA
ELLIPTA DPI inhaler will contain two individual blister strips with 30 blisters per strip; the first strip contains umeclidinium bromide (62.5 mcg per blister) blended with lactose monohydrate and magnesium stearate and second strip contains vilanterol trifenatae (25 mcg per blister) blended with lactose monohydrate and magnesium stearate.

Treatment: Drugs: UMEC 62.5 mcg via ELLIPTA
The ELLIPTA inhaler will contain one blister strip, which will have 30 blisters of umeclidinium bromide (62.5 mcg).

Treatment: Drugs: Salmeterol 50 mcg via DISKUS
The DISKUS inhaler will contain one blister strip, which will have 60 blisters of salmeterol xinafoate (50 mcg). The DISKUS will provide a total of 60 doses (60 blisters) and will deliver, when actuated, the contents of a single blister strip.

Treatment: Drugs: Placebo via ELLIPTA
Lactose dry powder will be administered using ELLIPTA for both treatment periods. ELLIPTA DPI inhaler will contain two individual blister strips with 30 blisters per strip; containing lactose dry powder.

Treatment: Drugs: Placebo via DISKUS
Lactose dry powder will be administered using DISKUS for both treatment periods. The DISKUS inhaler will contain one blister strip, which will have 60 blisters of lactose dry powder. The DISKUS will provide a total of 60 doses (60 blisters) and will deliver, when actuated, the contents of a single blister strip.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Week 24
Timepoint [1] 0 0
Baseline (Pre-dose on Day 1) and Week 24
Secondary outcome [1] 0 0
Self Administered Computerized (SAC) Transient Dyspnea Index (TDI) Focal Score at Week 24
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
Percentage of TDI Responders According to SAC TDI Focal Score
Timepoint [2] 0 0
Week 24
Secondary outcome [3] 0 0
Mean Change From Baseline in Evaluating Respiratory Symptoms (E-RS) Total Score
Timepoint [3] 0 0
Baseline (Pre-dose on Day 1) and Week 21 to Week 24
Secondary outcome [4] 0 0
Mean Change From Baseline in E-RS Subscale Score
Timepoint [4] 0 0
Baseline (Pre-dose on Day 1) and Week 21 to Week 24
Secondary outcome [5] 0 0
Percentage of E-RS Responders According to E-RS Total Score
Timepoint [5] 0 0
Week 21 to Week 24
Secondary outcome [6] 0 0
Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Total Score
Timepoint [6] 0 0
Baseline (Pre-dose on Day 1) and Week 24
Secondary outcome [7] 0 0
Percentage of Responders Based on the Saint (St) George Respiratory Questionnaire COPD Specific (SGRQ) Total Score
Timepoint [7] 0 0
Week 24
Secondary outcome [8] 0 0
Change From Baseline in COPD Assessment Test (CAT)
Timepoint [8] 0 0
Baseline (Pre-dose on Day 1) and Week 24
Secondary outcome [9] 0 0
Percentage of Responders According to CAT
Timepoint [9] 0 0
Week 24
Secondary outcome [10] 0 0
Number of Participants With on Treatment Adverse Events (AE) and Serious Adverse Events (SAE)
Timepoint [10] 0 0
Up to Week 24

Eligibility
Key inclusion criteria
Inclusion Criteria

- 40 years or older at date of signing informed consent at Screening Visit 1

- Outpatient with a diagnosis of COPD

- Persistent airflow limitations as indicated by a pre and post-albuterol/salbutamol
FEV1/FVC ratio of <0.70 and a post-albuterol/salbutamol FEV1 of >=30% to <=80%
predicted normal values at Screening Visit 1.

- A CAT score of >=10 at Screening Visit 1

- Current or former cigarette smokers with a history of cigarette smoking of >=10
pack-years (number of pack years = [number of cigarettes per day / 20] multiplied by
number of years smoked [e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per
day for 20 years both equal 10 pack-years]). Former smokers are defined as those who
have stopped smoking for at least 6 months prior to Visit 1. Pipe and/or cigar use
cannot be used to calculate pack-year history.

- Male and female subjects are eligible to participate in the study. A female subject is
eligible to participate if she is not pregnant (as confirmed by a negative urine human
chorionic gonadotrophin test), not lactating, and at least one of the following
conditions applies: non-reproductive potential defined as pre-menopausal females with
documented tubal ligation or documented hysteroscopic tubal occlusion procedure with
follow-up confirmation of bilateral tubal occlusion or hysterectomy or documented
bilateral oophorectomy. Postmenopausal defined as 12 months of spontaneous amenorrhea.
In questionable cases, a blood sample with simultaneous follicle stimulating hormone
and estradiol levels consistent with menopause must be tested. Females on hormone
replacement therapy (HRT) and whose menopausal status is in doubt will be required to
use one of the highly effective contraception methods if they wish to continue their
HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of
post-menopausal status prior to study enrolment.

A female subject with reproductive potential is eligible to participate if she is not
pregnant and agrees to follow one of the highly effective methods for avoiding pregnancy in
females of reproductive potential from 30 days prior to the first dose of study medication
and until (at least five terminal half-lives or until any continuing pharmacologic effect
has ended, whichever is longer) after the last dose of study medication and completion of
the follow-up visit. The investigator is responsible for ensuring that subjects understand
how to properly use methods of contraception.

- Capable of giving signed informed consent prior to study participation.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria

- A current diagnosis of asthma (Subjects with a prior history of asthma are eligible if
they have a current diagnosis of COPD, which is the primary cause of their respiratory
symptoms).

- Subjects with known alpha-antitrypsin deficiency as the underlying cause of COPD

- Subjects with active tuberculosis are excluded. Subjects with other respiratory
disorders (e.g., clinically significant: bronchiectasis, sarcoidosis, lung fibrosis,
pulmonary hypertension, interstitial lung diseases) are excluded if these conditions
are the primary cause of their respiratory symptoms.

- Current active liver or biliary disease (with the exception of Gilbert's syndrome or
asymptomatic gallstones or otherwise stable chronic liver disease as per investigator
assessment); stable chronic liver disease should generally be defined by the absence
of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric
varices, or persistent jaundice, or cirrhosis; chronic stable hepatitis B and C (e.g.,
presence of hepatitis B surface antigen or positive hepatitis C antibody test result
or within 3 months prior to first dose of study treatment) are acceptable if subject
otherwise meets entry criteria.

- Subjects with unstable or life threatening cardiac disease. The investigational
product should be used with caution in subjects with severe cardiovascular disease. In
the opinion of the investigator, use will only be considered if the benefit is likely
to outweigh the risk in conditions such as myocardial infarction or unstable angina in
the last 6 months, or unstable or life threatening cardiac arrhythmia requiring
intervention in the last 3 months, or New York Heart Association Class IV heart
failure.

- The investigator will determine the clinical significance of each abnormal
electrocardiogram (ECG) finding in relation to the subject's medical history and
exclude subjects who would be at undue risk by participating in the trial. Subjects
with the following abnormalities are excluded from participation in the study: atrial
fibrillation with rapid ventricular rate >120 beats per minute (bpm), sustained or
non-sustained ventricular tachycardia, second degree heart block Mobitz type II or
third degree heart block (unless pacemaker or defibrillator had been inserted).

- Subjects with medical conditions such as narrow-angle glaucoma, urinary retention,
prostatic hypertrophy, or bladder neck obstruction will be excluded unless, in the
opinion of the study physician, the benefit outweighs the risk.

- Any subject who is considered unlikely to survive the duration of the study period or
has any rapidly progressing disease or immediate life-threatening illness (e.g.,
cancer). In addition, any subject who has any other condition (e.g., neurological
condition) that is likely to affect respiratory function will not be included in the
study.

- Hospitalization for COPD or pneumonia within 12 weeks prior to Visit 1. Pneumonia
and/or moderate or severe COPD exacerbation that has not resolved at least 14 days
prior to Screening Visit 1and at least 30 days following the last dose of
oral/systemic corticosteroids (if applicable).

- Subjects who had received inhaled corticosteroids (ICS) or ICS/ long-acting
beta-agonist for the treatment of COPD in the 6 weeks prior to Screening Visit1.

- Subjects who had >1 moderate exacerbation in the 12 months prior to Screening Visit 1,
or one severe exacerbation requiring hospitalization in the 12 months prior to
Screening Visit 1.

- Other respiratory tract infections that have not resolved at least 7 days prior to
Screening Visit 1.

- Subjects with lung volume reduction surgery (including procedures such as
endobronchial valves) within the 12 months prior to Screening Visit 1.

- Use of long-term oxygen therapy described as resting oxygen therapy >3 Liter
(L)/minute (min) at screening required to maintain adequate oxygenation (e.g., oxygen
saturation in arterial blood [SaO2] >90%; oxygen use <=3 L/min flow is not
exclusionary, and subjects may adjust oxygen levels up or down as needed during the
study.)

- Use of ICS within 6 weeks prior to Screening Visit 1; use of depot corticosteroids
within 12 weeks prior to Screening Visit 1; use of systemic, oral or parenteral
corticosteroids within 6 weeks prior to Screening Visit 1 (Localized corticosteroid
injections [e.g., intra-articular and epidural] are permitted); use of antibiotics
(for lower respiratory tract infection) within 6 weeks prior to Screening Visit 1; use
of phosphodiesterase 4 (PDE4) inhibitor (e.g., roflumilast) within 14 days prior to
Screening Visit 1; use of long-acting beta-agonist/ ICS combination products within 6
weeks prior to Screening Visit 1; use of theophyllines within 48 hours prior to
Screening Visit 1; use of oral long-acting beta2-agonists within 48 hours and
short-acting beta2-agonists within 12 hours prior to Screening Visit 1; use of inhaled
short-acting beta2-agonists within 4 hours prior to Screening Visit 1 (use of study
provided albuterol/salbutamol is permitted during the study, except in the 4-hour
period prior to spirometry testing); use of inhaled short-acting anticholinergics
within 4 hours prior to Screening Visit 1; use of inhaled short-acting
anticholinergic/short-acting beta2-agonist combination products within 4 hours prior
to Screening Visit 1; use of any other investigational medication within 30 days or
within 5 drug half-lives (whichever is longer) prior to Screening Visit 1.

- Subject unable to withhold albuterol/salbutamol for the 4-hour period required prior
to spirometry testing at each study visit.

- Regular use (prescribed for daily/ regular use, not for as-needed use) of short-acting
bronchodilators (e.g., albuterol/salbutamol).

- A known or suspected history of alcohol or drug abuse within 2 years prior to
Screening Visit 1 that in the opinion of the investigator would prevent the subject
from completing the study procedures.

- Any history of allergy or hypersensitivity to any anticholinergic/muscarinic receptor
antagonist, sympathomimetic, lactose/milk protein or magnesium stearate.

- Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks
prior to Screening Visit 1. Subjects who are in the maintenance phase of a pulmonary
rehabilitation program are not excluded.

- Subject is an investigator, sub-investigator, study coordinator, employee of a
participating investigator or study site, or immediate family member of the
aforementioned that is involved in this study.

- In the opinion of the investigator, any subject who is unable to read and/or would not
be able to complete questionnaires on the electronic diary.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/06/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/06/2018
Sample size
Target
Accrual to date
Final
2696
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
GSK Investigational Site - Coffs Harbour
Recruitment hospital [2] 0 0
GSK Investigational Site - Darlinghurst, Sydney
Recruitment hospital [3] 0 0
GSK Investigational Site - Kanwal
Recruitment hospital [4] 0 0
GSK Investigational Site - Port Macquarie
Recruitment hospital [5] 0 0
GSK Investigational Site - Sydney
Recruitment postcode(s) [1] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst, Sydney
Recruitment postcode(s) [3] 0 0
2259 - Kanwal
Recruitment postcode(s) [4] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [5] 0 0
2010 - Sydney
Recruitment outside Australia
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Lund
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Skövde
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Stockholm
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Uppsala
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Sweden
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Örebro

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
COPD is characterized by an airflow limitation, which is not fully reversible, usually
progressive and accompanied by chronic cough, sputum production and dyspnea, which can be a
major cause of disability and anxiety associated with the disease. In addition, COPD is
associated with poor health-related quality of life (HRQoL). Pharmacologic therapy is used to
improve lung function, reduce symptoms, reduce the frequency and severity of exacerbations,
and also to improve health status and exercise tolerance.

This is a multi-center, randomized, double blind, double dummy, 3-arm parallel group study to
compare umeclidinium/vilanterol (62.5/25 microgram [mcg], once daily), umeclidinium (62.5
mcg, once daily), and salmeterol (50 mg, twice daily) in male and female subjects with COPD.
The primary purpose of this study is to demonstrate improvements in lung function for
subjects treated with UMEC/VI compared with UMEC for 24 weeks.

Approximately 2424 subjects will be randomized across 3 parallel arms in 1:1:1 ratio.
Subjects will be stratified based on long-acting bronchodilator usage during the run-in
period (none, one or 2 long-acting bronchodilators per day). Subjects will receive either
UMEC/VI inhalation powder (62.5/25 microgram [mcg] once daily) administered via the ELLIPTA®
dry powder inhaler (DPI) and placebo twice daily via DISKUS® DPI; or UMEC (62.5 mcg once
daily) administered via the ELLIPTA DPI and placebo twice daily via DISKUS DPI or salmeterol
(50 mcg twice daily [BID]) administered via the DISKUS DPI and placebo once daily via ELLIPTA
DPI. The duration of the study will be 29 to 31 weeks including a pre-screening period of 2
weeks, run-in period of 4 weeks, treatment period of 24 weeks and follow-up period of 1 week.

ELLIPTA and DISKUS are trademarks of GSK group of companies.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03034915
Trial related presentations / publications
Maltais F, Bjermer L, Kerwin EM, Jones PW, Watkins ML, Tombs L, Naya IP, Boucot IH, Lipson DA, Compton C, Vahdati-Bolouri M, Vogelmeier CF. Efficacy of umeclidinium/vilanterol versus umeclidinium and salmeterol monotherapies in symptomatic patients with COPD not receiving inhaled corticosteroids: the EMAX randomised trial. Respir Res. 2019 Oct 30;20(1):238. doi: 10.1186/s12931-019-1193-9.
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03034915