A 24-week Study to Compare Umeclidinium/Vilanterol (UMEC/... | NCT03034915

ID	Type	Description	Link
2016-002513-22	EudraCT Number

Label	Type	Description	Intervention Names
UMEC/VI 62.5/25 mcg via ELLIPTA + placebo via DISKUS	Experimental	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.	Drug: UMEC/VI 62.5/25 mcg via ELLIPTA Drug: Placebo via DISKUS
UMEC 62.5 mcg via ELLIPTA + placebo via DISKUS	Experimental	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.	Drug: UMEC 62.5 mcg via ELLIPTA Drug: Placebo via DISKUS
Salmeterol 50 mcg via DISKUS + placebo via ELLIPTA	Experimental	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.	Drug: Salmeterol 50 mcg via DISKUS Drug: Placebo via ELLIPTA

Name	Type	Description	Arm Group Labels	Other Names
UMEC/VI 62.5/25 mcg via ELLIPTA	Drug	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.

Measure	Description	Time Frame
Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Week 24	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 at Week 24 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on the previous day. Baseline trough FEV1 is the mean of the values measured at 30 minutes and 5 minutes pre-dose on Day 1. Change from Baseline was calculated as the trough FEV1 value on Week 24 minus the Baseline value. Analysis was performed using a repeated measures model (MMRM) with covariates of Baseline FEV1, geographical region, stratum (number of bronchodilators per day during run-in), visit, treatment, visit by Baseline and visit by treatment interaction. ITT population comprised of all randomized participants (excluding those who were randomized in error) who received at least one dose of study medication.	Baseline (Pre-dose on Day 1) and Week 24

Measure	Description	Time Frame
Self Administered Computerized (SAC) Transient Dyspnea Index (TDI) Focal Score at Week 24	TDI focal score comprises of 3 individual scales (Functional Impairment, Magnitude of Task, Magnitude of Effort). Each of these scales had a possible score ranging from -6 to +6, lower scores indicates impairment. TDI focal score was calculated as the sum of 3 individual scores (range is -18 to +18). Lower score indicates deterioration of dyspnea. If a score is missing for any of the three scales, then the TDI focal score was set to missing. Analysis was performed using mixed model repeated measures (MMRM) with covariates of SAC BDI focal score, geographical region, stratum (no. of bronchodilators per day during run-in), visit, treatment, visit by SAC BDI and visit by treatment interactions.

Eligibility Module

Eligibility 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.

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.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Phoenix	Arizona	85018	United States
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
31666084	Background	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.
37800633

ID	Title	Description
FG000	UMEC/VI 62.5/25 mcg+ Placebo	Participants with COPD received UMEC/VI 62.5/25 mcg once daily via the ELLIPTA DPI along with placebo twice daily via the DISKUS DPI for 24 weeks. In addition albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the study. Participants were followed up 7 days after the last dose of study medication.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 18, 2017	Jun 3, 2019

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Week 24

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 at Week 24 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on the previous day. Baseline trough FEV1 is the mean of the values measured at 30 minutes and 5 minutes pre-dose on Day 1. Change from Baseline was calculated as the trough FEV1 value on Week 24 minus the Baseline value. Analysis was performed using a repeated measures model (MMRM) with covariates of Baseline FEV1, geographical region, stratum (number of bronchodilators per day during run-in), visit, treatment, visit by Baseline and visit by treatment interaction. ITT population comprised of all randomized participants (excluding those who were randomized in error) who received at least one dose of study medication.

ITT Population. Participants represents those with data available at the time point being presented; however, all participants in the ITT population without missing covariate information and with at least one post Baseline measurement are included in the analysis.

Posted

Least Squares Mean

Standard Error

Liters

Baseline (Pre-dose on Day 1) and Week 24

ID	Title	Description
OG000	UMEC/VI 62.5/25 mcg+ Placebo	Participants with COPD received UMEC/VI 62.5/25 mcg once daily via the ELLIPTA DPI along with placebo twice daily via the DISKUS DPI for 24 weeks. In addition albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the study. Participants were followed up 7 days after the last dose of study medication.
OG001	UMEC 62.5 mcg + Placebo	Participants with COPD received UMEC 62.5mcg once daily via the ELLIPTA DPI along with placebo twice daily via DISKUS DPI for 24 weeks. In addition albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the study. Participants were followed up 7 days after the last dose of study medication.
OG002	Salmeterol 50 mcg+Placebo	Participants with COPD received salmeterol 50 mcg twice daily via the DISKUS DPI along with placebo once daily via ELLIPTA DPI for 24 weeks. In addition albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the study. Participants were followed up 7 days after the last dose of study medication.

Units	Counts
Participants	OG000691 OG001621 OG002654

Title

Denominators

Categories

Title	Measurements
	OG0000.122± 0.0081 OG0010.056± 0.0085 OG002-0.019± 0.0083

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Mixed model repeated measures		<0.001		Mean Difference (Net)	0.066	Standard Error of the Mean	0.0118	2-Sided	95	0.043	0.089			LS Mean difference comparing UMEC/VI versus UMEC at Week 24.		Other
OG000 OG002		Mixed model repeated measures

Secondary

Self Administered Computerized (SAC) Transient Dyspnea Index (TDI) Focal Score at Week 24

TDI focal score comprises of 3 individual scales (Functional Impairment, Magnitude of Task, Magnitude of Effort). Each of these scales had a possible score ranging from -6 to +6, lower scores indicates impairment. TDI focal score was calculated as the sum of 3 individual scores (range is -18 to +18). Lower score indicates deterioration of dyspnea. If a score is missing for any of the three scales, then the TDI focal score was set to missing. Analysis was performed using mixed model repeated measures (MMRM) with covariates of SAC BDI focal score, geographical region, stratum (no. of bronchodilators per day during run-in), visit, treatment, visit by SAC BDI and visit by treatment interactions.

Posted

Least Squares Mean

Standard Error

Scores on a scale

Week 24

ID	Title	Description
OG000	UMEC/VI 62.5/25 mcg+ Placebo	Participants with COPD received UMEC/VI 62.5/25 mcg once daily via the ELLIPTA DPI along with placebo twice daily via the DISKUS DPI for 24 weeks. In addition albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the study. Participants were followed up 7 days after the last dose of study medication.
OG001	UMEC 62.5 mcg + Placebo

Secondary

Percentage of TDI Responders According to SAC TDI Focal Score

TDI focal score comprises of 3 individual scales (Functional Impairment, Magnitude of Task, Magnitude of Effort). Each of these scales had a possible score ranging from -6 to +6, lower scores indicates impairment. TDI focal score was calculated as the sum of 3 individual scores (range is -18 to +18). Lower score indicates deterioration of dyspnea. If a score is missing for any of the three scales, then TDI focal score was set to missing. A participant was considered as a responder if the on-treatment TDI focal score was at least 1 unit at that visit. Non-response was SAC TDI focal score of less than 1 unit or a missing SAC TDI focal score with no subsequent non-missing on-treatment scores. Analysis was performed using a generalized linear mixed model with treatment as an explanatory variable and visit, SAC BDI focal score, stratum (no. of bronchodilators per day during run-in), geographical region, visit by SAC BDI and visit by treatment interactions included as covariates.

Posted

Number

Percentage of responders

Week 24

ID	Title	Description
OG000	UMEC/VI 62.5/25 mcg+ Placebo	Participants with COPD received UMEC/VI 62.5/25 mcg once daily via the ELLIPTA DPI along with placebo twice daily via the DISKUS DPI for 24 weeks. In addition albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the study. Participants were followed up 7 days after the last dose of study medication.

Secondary

Mean Change From Baseline in Evaluating Respiratory Symptoms (E-RS) Total Score

The E-RS is intended to capture information related to respiratory symptoms. A daily symptom score for E-RS is derived by summing 11 item-scores. The domains include: respiratory symptoms (RS)-breathlessness (RS-BRL comprised of 5 items, score range [0-17]), RS-cough and sputum (RS-CSP comprised of 3 items, score range [0-11]), and RS-chest symptoms (RS-CSY comprised of 3 items, score range [0-12]). Total score ranged between 0-40 and higher values indicates severe respiratory symptoms. The instrument was completed each night prior to going to bed. Baseline E-RS score is the mean within-participant daily score over 7 days prior to randomization. Change from Baseline is the difference at Week 21-Week 24 value and Baseline value. Analysis was performed using MMRM with covariates of Baseline score, geographical region, stratum (no. of bronchodilators per day during run-in), 4-weekly period, treatment, 4-weekly period by Baseline and 4-weekly period by treatment interactions.

Posted

Least Squares Mean

Standard Error

Scores on a scale

Baseline (Pre-dose on Day 1) and Week 21 to Week 24

ID	Title	Description
OG000	UMEC/VI 62.5/25 mcg+ Placebo	Participants with COPD received UMEC/VI 62.5/25 mcg once daily via the ELLIPTA DPI along with placebo twice daily via the DISKUS DPI for 24 weeks. In addition albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the study. Participants were followed up 7 days after the last dose of study medication.

Secondary

Mean Change From Baseline in E-RS Subscale Score

Posted

Least Squares Mean

Standard Error

Scores on a scale

Baseline (Pre-dose on Day 1) and Week 21 to Week 24

ID	Title	Description
OG000	UMEC/VI 62.5/25 mcg+ Placebo	Participants with COPD received UMEC/VI 62.5/25 mcg once daily via the ELLIPTA DPI along with placebo twice daily via the DISKUS DPI for 24 weeks. In addition albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the study. Participants were followed up 7 days after the last dose of study medication.

Secondary

Percentage of E-RS Responders According to E-RS Total Score

The E-RS is intended to capture information related to respiratory symptoms. A daily symptom score for E-RS is derived by summing 11 item-scores. The domains include: RS-BRL comprised of 5 items, score range (0-17); RS-CSP comprised of 3 items, score range (0-11); and RS-CSY comprised of 4 items, score range (0-12). Total score ranged between 0-40 and higher values indicates severe respiratory symptoms. The instrument was completed each night prior to going to bed. Response is defined as an E-RS total score of at least 2 or 3.35 below Baseline. Participants with a Baseline but all missing post-Baseline data are also considered a non-responder. Analysis was performed using a generalized linear mixed model with treatment as an explanatory variable and four-weekly period, Baseline score, stratum (no. of bronchodilators per day during run-in), geographical region, four-weekly period by baseline and four-weekly period by treatment interactions included as covariates.

Posted

Number

Percentage of responders

Week 21 to Week 24

ID	Title	Description
OG000	UMEC/VI 62.5/25 mcg+ Placebo	Participants with COPD received UMEC/VI 62.5/25 mcg once daily via the ELLIPTA DPI along with placebo twice daily via the DISKUS DPI for 24 weeks. In addition albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the study. Participants were followed up 7 days after the last dose of study medication.

Secondary

Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Total Score

SGRQ is a disease-specific questionnaire designed to measure impact of respiratory disease and its treatment on HRQoL of participants with COPD. It contains 14 questions with a total of 40 items grouped into domains (Symptoms, Activity and Impacts). SGRQ total score was calculated as 100 multiplied by summed weights from all positive items divided by sum of weights for all items in questionnaire. It ranges from 0 to 100, higher score indicates poor HRQoL. Baseline is last non-missing score recorded prior to dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the value at Week 24. Analysis was performed using mixed model repeated measures (MMRM) with covariates of Baseline SGRQ total score, geographical region, stratum (no. of bronchodilators per day during run-in), visit, treatment, visit by Baseline and visit by treatment interactions.

Posted

Least Squares Mean

Standard Error

Scores on a scale

Baseline (Pre-dose on Day 1) and Week 24

ID	Title	Description
OG000	UMEC/VI 62.5/25 mcg+ Placebo	Participants with COPD received UMEC/VI 62.5/25 mcg once daily via the ELLIPTA DPI along with placebo twice daily via the DISKUS DPI for 24 weeks. In addition albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the study. Participants were followed up 7 days after the last dose of study medication.

Secondary

Percentage of Responders Based on the Saint (St) George Respiratory Questionnaire COPD Specific (SGRQ) Total Score

SGRQ is a disease-specific questionnaire designed to measure impact of respiratory disease and its treatment on HRQoL of participants with COPD. It contains 14 questions with a total of 40 items grouped into domains (Symptoms, Activity and Impacts). SGRQ total score was calculated as 100 multiplied by summed weights from all positive items divided by sum of weights for all items in questionnaire. It ranges from 0 to 100, higher score indicates poor HRQoL. Analysis was performed using a generalized linear mixed model with treatment as an explanatory variable and visit, Baseline SGRQ score, stratum (no. of bronchodilators per day during run-in), geographical region, visit by Baseline and visit by treatment interactions included as covariates. Response was defined as an SGRQ total score of 4 or more units below Baseline.

Posted

Number

Percentage of responders

Week 24

ID	Title	Description
OG000	UMEC/VI 62.5/25 mcg+ Placebo	Participants with COPD received UMEC/VI 62.5/25 mcg once daily via the ELLIPTA DPI along with placebo twice daily via the DISKUS DPI for 24 weeks. In addition albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the study. Participants were followed up 7 days after the last dose of study medication.

Secondary

Change From Baseline in COPD Assessment Test (CAT)

The CAT is a participant-completed instrument designed to provide a simple and reliable measure of health status in COPD for the assessment and long-term follow-up of the individual participant. The CAT consists of eight items, each formatted on a differential scale. Participants rated their experience on a 6-point scale for each question, ranging from 0 (no impact) to 5 (high impact). A total CAT score was calculated by summing the non-missing scores on the eight items ranging from 0 to 40 with higher scores indicating greater disease impact. Baseline is defined as the last non-missing score recorded prior to dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the value at Week 24. Analysis was performed using mixed model repeated measures (MMRM) with covariates of Baseline CAT score, geographical region, stratum (no. of bronchodilators per day during run-in), visit, treatment, visit by Baseline and visit by treatment interactions.

ITT population. Participants represents those with data available at the time point being presented; however, all participants in the ITT population without missing covariate information and with at least one post Baseline measurement are included in the analysis.

Posted

Least Squares Mean

Standard Error

Scores on a scale

Baseline (Pre-dose on Day 1) and Week 24

ID	Title	Description
OG000	UMEC/VI 62.5/25 mcg+ Placebo	Participants with COPD received UMEC/VI 62.5/25 mcg once daily via the ELLIPTA DPI along with placebo twice daily via the DISKUS DPI for 24 weeks. In addition albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the study. Participants were followed up 7 days after the last dose of study medication.

Secondary

Percentage of Responders According to CAT

The CAT is a participant-completed instrument designed to provide a simple and reliable measure of health status in COPD for the assessment and long-term follow-up of the individual participant. The CAT consists of eight items. Participants rated their experience on a 6-point scale for each question, ranging from 0 (no impact) to 5 (high impact). A total CAT score was calculated by summing the non-missing scores on the eight items ranging from 0 to 40 with higher scores indicate greater disease impact. Response was defined as an CAT score of >=2 below Baseline. Non response was defined as CAT score <2 units below Baseline or a missing CAT score with no subsequent on treatment scores. Analysis performed using a generalized linear mixed model with treatment as an explanatory variable and visit, baseline CAT score, stratum (no. of bronchodilators per day during run-in), geographical region, visit by baseline and visit by treatment interactions included as covariates.

ITT Population.

Posted

Number

Percentage of responders

Week 24

ID	Title	Description
OG000	UMEC/VI 62.5/25 mcg+ Placebo	Participants with COPD received UMEC/VI 62.5/25 mcg once daily via the ELLIPTA DPI along with placebo twice daily via the DISKUS DPI for 24 weeks. In addition albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the study. Participants were followed up 7 days after the last dose of study medication.
OG001	UMEC 62.5 mcg + Placebo

Secondary

Number of Participants With on Treatment Adverse Events (AE) and Serious Adverse Events (SAE)

An AE is any untoward medical occurrence in a participant or clinical investigation participant , temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events associated with liver injury and impaired liver function based on pre-defined criteria were categorized as SAE.

ITT Population.

Posted

Number

Participants

Up to Week 24

ID	Title	Description
OG000	UMEC/VI 62.5/25 mcg+ Placebo	Participants with COPD received UMEC/VI 62.5/25 mcg once daily via the ELLIPTA DPI along with placebo twice daily via the DISKUS DPI for 24 weeks. In addition albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the study. Participants were followed up 7 days after the last dose of study medication.
OG001	UMEC 62.5 mcg + Placebo	Participants with COPD received UMEC 62.5mcg once daily via the ELLIPTA DPI along with placebo twice daily via DISKUS DPI for 24 weeks. In addition albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the study. Participants were followed up 7 days after the last dose of study medication.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0007 events7 affected812 at risk EG0017 events7 affected804 at risk EG0029 events9 affected809 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected812 at risk EG0011 events1 affected804 at risk EG0021 events1 affected809 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected812 at risk EG0011 events1 affected804 at risk EG0020 events0 affected809 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected812 at risk EG0011 events1 affected804 at risk EG0020 events0 affected809 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected812 at risk EG0010 events0 affected804 at risk EG0020 events0 affected809 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected812 at risk EG0010 events0 affected804 at risk EG0020 events0 affected809 at risk
Pneumonia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected812 at risk EG0014 events4 affected804 at risk EG0025 events5 affected809 at risk
Sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected812 at risk EG0010 events0 affected804 at risk EG0020 events0 affected809 at risk
Appendicitis perforated	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected812 at risk EG0011 events1 affected804 at risk EG0020 events0 affected809 at risk
Bacterial colitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected812 at risk EG0010 events0 affected804 at risk EG0021 events1 affected809 at risk
Encephalitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected812 at risk EG0011 events1 affected804 at risk EG0020 events0 affected809 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected812 at risk EG0010 events0 affected804 at risk EG0021 events1 affected809 at risk
Muscle abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected812 at risk EG0010 events0 affected804 at risk EG0020 events0 affected809 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected812 at risk EG0010 events0 affected804 at risk EG0020 events0 affected809 at risk
Septic shock	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected812 at risk EG0010 events0 affected804 at risk EG0020 events0 affected809 at risk
Urinary tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected812 at risk EG0011 events1 affected804 at risk EG0020 events0 affected809 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected812 at risk EG0012 events1 affected804 at risk EG0022 events2 affected809 at risk
Coronary artery disease	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected812 at risk EG0012 events2 affected804 at risk EG0020 events0 affected809 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected812 at risk EG0011 events1 affected804 at risk EG0020 events0 affected809 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected812 at risk EG0011 events1 affected804 at risk EG0020 events0 affected809 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected812 at risk EG0010 events0 affected804 at risk EG0020 events0 affected809 at risk
Angina pectoris	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected812 at risk EG0010 events0 affected804 at risk EG0021 events1 affected809 at risk
Angina unstable	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected812 at risk EG0010 events0 affected804 at risk EG0020 events0 affected809 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected812 at risk EG0011 events1 affected804 at risk EG0020 events0 affected809 at risk
Cardiac arrest	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected812 at risk EG0010 events0 affected804 at risk EG0020 events0 affected809 at risk
Cardiac failure	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected812 at risk EG0011 events1 affected804 at risk EG0020 events0 affected809 at risk
Tachycardia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected812 at risk EG0010 events0 affected804 at risk EG0020 events0 affected809 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected812 at risk EG0010 events0 affected804 at risk EG0021 events1 affected809 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected812 at risk EG0010 events0 affected804 at risk EG0021 events1 affected809 at risk
Small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected812 at risk EG0011 events1 affected804 at risk EG0021 events1 affected809 at risk
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected812 at risk EG0010 events0 affected804 at risk EG0021 events1 affected809 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected812 at risk EG0011 events1 affected804 at risk EG0020 events0 affected809 at risk
Adenosquamous cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected812 at risk EG0010 events0 affected804 at risk EG0020 events0 affected809 at risk
Benign lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected812 at risk EG0010 events0 affected804 at risk EG0020 events0 affected809 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected812 at risk EG0010 events0 affected804 at risk EG0020 events0 affected809 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected812 at risk EG0010 events0 affected804 at risk EG0020 events0 affected809 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected812 at risk EG0010 events0 affected804 at risk EG0020 events0 affected809 at risk
Non-small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected812 at risk EG0010 events0 affected804 at risk EG0021 events1 affected809 at risk
Papillary cystadenoma lymphomatosum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected812 at risk EG0011 events1 affected804 at risk EG0020 events0 affected809 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected812 at risk EG0010 events0 affected804 at risk EG0021 events1 affected809 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected812 at risk EG0010 events0 affected804 at risk EG0020 events0 affected809 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected812 at risk EG0010 events0 affected804 at risk EG0020 events0 affected809 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected812 at risk EG0011 events1 affected804 at risk EG0020 events0 affected809 at risk
Enteritis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected812 at risk EG0010 events0 affected804 at risk EG0021 events1 affected809 at risk
Enterocolitis haemorrhagic	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected812 at risk EG0011 events1 affected804 at risk EG0020 events0 affected809 at risk
Femoral hernia strangulated	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected812 at risk EG0010 events0 affected804 at risk EG0020 events0 affected809 at risk
Gastric polyps	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected812 at risk EG0010 events0 affected804 at risk EG0020 events0 affected809 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected812 at risk EG0011 events1 affected804 at risk EG0020 events0 affected809 at risk
Gastritis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected812 at risk EG0010 events0 affected804 at risk EG0020 events0 affected809 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected812 at risk EG0010 events0 affected804 at risk EG0020 events0 affected809 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected812 at risk EG0011 events1 affected804 at risk EG0020 events0 affected809 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected812 at risk EG0010 events0 affected804 at risk EG0020 events0 affected809 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected812 at risk EG0010 events0 affected804 at risk EG0021 events1 affected809 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected812 at risk EG0010 events0 affected804 at risk EG0020 events0 affected809 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected812 at risk EG0010 events0 affected804 at risk EG0020 events0 affected809 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected812 at risk EG0011 events1 affected804 at risk EG0020 events0 affected809 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected812 at risk EG0010 events0 affected804 at risk EG0021 events1 affected809 at risk
Post-thoracotomy pain syndrome	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected812 at risk EG0010 events0 affected804 at risk EG0020 events0 affected809 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected812 at risk EG0010 events0 affected804 at risk EG0020 events0 affected809 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected812 at risk EG0010 events0 affected804 at risk EG0021 events1 affected809 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected812 at risk EG0010 events0 affected804 at risk EG0021 events1 affected809 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected812 at risk EG0012 events2 affected804 at risk EG0021 events1 affected809 at risk
Haematoma	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected812 at risk EG0010 events0 affected804 at risk EG0020 events0 affected809 at risk
Aortic stenosis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected812 at risk EG0011 events1 affected804 at risk EG0020 events0 affected809 at risk
Hypertensive emergency	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected812 at risk EG0010 events0 affected804 at risk EG0020 events0 affected809 at risk
Hypotension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected812 at risk EG0010 events0 affected804 at risk EG0021 events1 affected809 at risk
Subclavian artery stenosis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected812 at risk EG0010 events0 affected804 at risk EG0020 events0 affected809 at risk
Varicose vein	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected812 at risk EG0010 events0 affected804 at risk EG0021 events1 affected809 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected812 at risk EG0011 events1 affected804 at risk EG0020 events0 affected809 at risk
Basilar artery stenosis	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected812 at risk EG0011 events1 affected804 at risk EG0020 events0 affected809 at risk
Brain stem stroke	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected812 at risk EG0011 events1 affected804 at risk EG0020 events0 affected809 at risk
Cerebellar infarction	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected812 at risk EG0010 events0 affected804 at risk EG0020 events0 affected809 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected812 at risk EG0010 events0 affected804 at risk EG0021 events1 affected809 at risk
Encephalopathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected812 at risk EG0011 events1 affected804 at risk EG0020 events0 affected809 at risk
Presyncope	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected812 at risk EG0010 events0 affected804 at risk EG0021 events1 affected809 at risk
Status epilepticus	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected812 at risk EG0011 events1 affected804 at risk EG0020 events0 affected809 at risk
Tethered cord syndrome	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected812 at risk EG0011 events1 affected804 at risk EG0020 events0 affected809 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected812 at risk EG0010 events0 affected804 at risk EG0020 events0 affected809 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected812 at risk EG0010 events0 affected804 at risk EG0021 events1 affected809 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected812 at risk EG0010 events0 affected804 at risk EG0021 events1 affected809 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected812 at risk EG0010 events0 affected804 at risk EG0021 events1 affected809 at risk
Non-cardiac chest pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected812 at risk EG0011 events1 affected804 at risk EG0021 events1 affected809 at risk
Asthenia	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected812 at risk EG0011 events1 affected804 at risk EG0020 events0 affected809 at risk
Oedema peripheral	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected812 at risk EG0011 events1 affected804 at risk EG0020 events0 affected809 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected812 at risk EG0010 events0 affected804 at risk EG0021 events1 affected809 at risk
Microcytic anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected812 at risk EG0011 events1 affected804 at risk EG0020 events0 affected809 at risk
Splenic infarction	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected812 at risk EG0010 events0 affected804 at risk EG0020 events0 affected809 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected812 at risk EG0011 events1 affected804 at risk EG0020 events0 affected809 at risk
Renal failure	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected812 at risk EG0011 events1 affected804 at risk EG0020 events0 affected809 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected812 at risk EG0010 events0 affected804 at risk EG0021 events1 affected809 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected812 at risk EG0010 events0 affected804 at risk EG0020 events0 affected809 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected812 at risk EG0010 events0 affected804 at risk EG0020 events0 affected809 at risk
Depression	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected812 at risk EG0010 events0 affected804 at risk EG0021 events1 affected809 at risk

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D000420	Albuterol
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals
D000588	Amines
D010627	Phenethylamines
D005021	Ethylamines

ID	Title	Description
BG000	UMEC/VI 62.5/25 mcg+ Placebo	Participants with COPD received UMEC/VI 62.5/25 mcg once daily via the ELLIPTA DPI along with placebo twice daily via the DISKUS DPI for 24 weeks. In addition albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the study. Participants were followed up 7 days after the last dose of study medication.
BG001	UMEC 62.5 mcg + Placebo	Participants with COPD received UMEC 62.5mcg once daily via the ELLIPTA DPI along with placebo twice daily via DISKUS DPI for 24 weeks. In addition albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the study. Participants were followed up 7 days after the last dose of study medication.
BG002	Salmeterol 50 mcg+Placebo	Participants with COPD received salmeterol 50 mcg twice daily via the DISKUS DPI along with placebo once daily via ELLIPTA DPI for 24 weeks. In addition albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the study. Participants were followed up 7 days after the last dose of study medication.
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	UMEC/VI 62.5/25 mcg+ Placebo	Participants with COPD received UMEC/VI 62.5/25 mcg once daily via the ELLIPTA DPI along with placebo twice daily via the DISKUS DPI for 24 weeks. In addition albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the study. Participants were followed up 7 days after the last dose of study medication.	4	812	49	812	68	812
EG001	UMEC 62.5 mcg + Placebo	Participants with COPD received UMEC 62.5mcg once daily via the ELLIPTA DPI along with placebo twice daily via DISKUS DPI for 24 weeks. In addition albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the study. Participants were followed up 7 days after the last dose of study medication.	4	804	35	804	87	804
EG002	Salmeterol 50 mcg+Placebo	Participants with COPD received salmeterol 50 mcg twice daily via the DISKUS DPI along with placebo once daily via ELLIPTA DPI for 24 weeks. In addition albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the study. Participants were followed up 7 days after the last dose of study medication.	0	809	38	809	84	809