A 24-week Study to Compare Umeclidinium/Vilanterol (UMEC/VI), UMEC and Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
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)
2 other identifiers
interventional
2,696
12 countries
212
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2017
Shorter than P25 for phase_4
212 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 25, 2017
CompletedFirst Posted
Study publicly available on registry
January 27, 2017
CompletedStudy Start
First participant enrolled
June 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 18, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 18, 2018
CompletedResults Posted
Study results publicly available
July 15, 2019
CompletedMarch 11, 2020
March 1, 2020
1 year
January 25, 2017
June 16, 2019
March 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (10)
Self Administered Computerized (SAC) Transient Dyspnea Index (TDI) Focal Score at Week 24
Week 24
Percentage of TDI Responders According to SAC TDI Focal Score
Week 24
Mean Change From Baseline in Evaluating Respiratory Symptoms (E-RS) Total Score
Baseline (Pre-dose on Day 1) and Week 21 to Week 24
Mean Change From Baseline in E-RS Subscale Score
Baseline (Pre-dose on Day 1) and Week 21 to Week 24
Percentage of E-RS Responders According to E-RS Total Score
Week 21 to Week 24
- +5 more secondary outcomes
Study Arms (3)
UMEC/VI 62.5/25 mcg via ELLIPTA + placebo via DISKUS
EXPERIMENTALSubjects 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.
UMEC 62.5 mcg via ELLIPTA + placebo via DISKUS
EXPERIMENTALSubjects 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.
Salmeterol 50 mcg via DISKUS + placebo via ELLIPTA
EXPERIMENTALSubjects 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.
Interventions
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.
The ELLIPTA inhaler will contain one blister strip, which will have 30 blisters of umeclidinium bromide (62.5 mcg).
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 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.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (212)
GSK Investigational Site
Phoenix, Arizona, 85018, United States
GSK Investigational Site
Lincoln, California, 95648, United States
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Clearwater, Florida, 33765, United States
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Orlando, Florida, 32825, United States
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Tampa, Florida, 33603, United States
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O'Fallon, Illinois, 62269, United States
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Natchitoches, Louisiana, 71457, United States
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Edina, Minnesota, 55435, United States
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Fridley, Minnesota, 55432, United States
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Minneapolis, Minnesota, 55407, United States
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Woodbury, Minnesota, 55125, United States
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Chesterfield, Missouri, 63017, United States
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Saint Charles, Missouri, 63301, United States
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St Louis, Missouri, 63141, United States
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Omaha, Nebraska, 68134, United States
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Albuquerque, New Mexico, 87108, United States
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Charlotte, North Carolina, 28207, United States
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Gastonia, North Carolina, 28054, United States
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Monroe, North Carolina, 28112, United States
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Mooresville, North Carolina, 28117, United States
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Winston-Salem, North Carolina, 27103, United States
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Cincinnati, Ohio, 45231, United States
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Medford, Oregon, 97504, United States
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Anderson, South Carolina, 29621, United States
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Charleston, South Carolina, 29406-7108, United States
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Easley, South Carolina, 29640, United States
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Gaffney, South Carolina, 29340, United States
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Greenville, South Carolina, 29615, United States
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Lancaster, South Carolina, 29720, United States
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Mt. Pleasant, South Carolina, 29464, United States
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Rock Hill, South Carolina, 29732, United States
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Seneca, South Carolina, 29678, United States
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Spartanburg, South Carolina, 29303, United States
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Union, South Carolina, 29379, United States
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Sherman, Texas, 75092, United States
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Abingdon, Virginia, 24210, United States
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Morgantown, West Virginia, 26505, United States
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Ciudad Autonoma de Buenos Aires, Buenos Aires, C1028AAP, Argentina
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Ciudad Autonoma de Buenos Aires, Buenos Aires, C1414AIF, Argentina
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Ciudad Autonoma de Buenos Aires, Buenos Aires, C1425AGC, Argentina
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Florida, Buenos Aires, 1602, Argentina
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La Plata, Buenos Aires, Argentina
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Lobos, Buenos Aires, 7240, Argentina
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Mar del Plata, Buenos Aires, 7600, Argentina
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Mar del Plata, Buenos Aires, B7600FZN, Argentina
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Paraná, Buenos Aires, E3100BHK, Argentina
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Quilmes, Buenos Aires, B1878FNR, Argentina
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Vicente López, Buenos Aires, B1602DOH, Argentina
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Córdoba, Córdoba Province, X5003DCE, Argentina
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Concepción del Uruguay, Entre Ríos Province, 3260, Argentina
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San Rafael, Mendoza Province, 5600, Argentina
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Rosario, Santa Fe Province, 2000, Argentina
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Rosario, Santa Fe Province, S2002OJN, Argentina
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Buenos Aires, C1120AAC, Argentina
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Buenos Aires, C1121ABE, Argentina
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Buenos Aires, C1128AAF, Argentina
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Buenos Aires, C1424BSF, Argentina
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Buenos Aires, C1425BEN, Argentina
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Buenos Aires, C1426ABP, Argentina
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Capital Federal, C1440BRR, Argentina
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Ciudad Autonoma de Buenis Aires, C1015ABR, Argentina
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Mendoza, 5500, Argentina
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Mendoza, 5501, Argentina
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Mendoza, M5500CCG, Argentina
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Monte Grande, 1842, Argentina
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San Miguel de Tucumán, 4000, Argentina
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San Miguel de Tucumán, T4000DGF, Argentina
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Santa Fe, 3000, Argentina
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Santa Rosa, 6300, Argentina
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Coffs Harbour, New South Wales, 2450, Australia
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Darlinghurst, Sydney, New South Wales, 2010, Australia
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Kanwal, New South Wales, 2259, Australia
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Port Macquarie, New South Wales, 2444, Australia
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Sydney, New South Wales, 2010, Australia
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Moncton, New Brunswick, E1G1A7, Canada
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Truro, Nova Scotia, B2N 1L2, Canada
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Hamilton, Ontario, L8L 5G8, Canada
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London, Ontario, N5W 6A2, Canada
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Sarnia, Ontario, N7T 4X3, Canada
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Toronto, Ontario, M9V 4B4, Canada
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Windsor, Ontario, N8X 1T3, Canada
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Gatineau, Quebec, J8Y 6S8, Canada
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Mirabel, Quebec, J7J 2K8, Canada
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Montreal, Quebec, H1M 1B1, Canada
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Québec, Quebec, G1V 4G5, Canada
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Québec, Quebec, G1W 4R4, Canada
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Saint-Charles-Borromée, Quebec, J6E 2B4, Canada
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Marseille, 13331, France
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Nice, 06000, France
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Perpignan, 66000, France
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Pessac, 33604, France
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Karlsruhe, Baden-Wurttemberg, 76137, Germany
GSK Investigational Site
Wiesloch, Baden-Wurttemberg, 69168, Germany
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Bamberg, Bavaria, 96049, Germany
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Erlangen, Bavaria, 91052, Germany
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Munich, Bavaria, 80339, Germany
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Munich, Bavaria, 81241, Germany
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Potsdam, Brandenburg, 14469, Germany
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Rüdersdorf, Brandenburg, 15562, Germany
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Darmstadt, Hesse, 64283, Germany
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Frankfurt am Main, Hesse, 60389, Germany
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Frankfurt am Main, Hesse, 60596, Germany
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Fulda, Hesse, 36039, Germany
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Kassel, Hesse, 34121, Germany
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Marburg, Hesse, 35037, Germany
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Neu-Isenburg, Hesse, 63263, Germany
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Hanover, Lower Saxony, 30159, Germany
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Hanover, Lower Saxony, 30167, Germany
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Hanover, Lower Saxony, 30173, Germany
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Osnabrück, Lower Saxony, 49074, Germany
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Peine, Lower Saxony, 31224, Germany
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Wardenburg, Lower Saxony, 26203, Germany
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Schwerin, Mecklenburg-Vorpommern, 19055, Germany
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Bergisch Gladbach, North Rhine-Westphalia, 51429, Germany
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Bochum, North Rhine-Westphalia, 44787, Germany
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Bonn, North Rhine-Westphalia, 53119, Germany
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Bonn, North Rhine-Westphalia, 53123, Germany
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Cologne, North Rhine-Westphalia, 51069, Germany
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Dortmund, North Rhine-Westphalia, 44263, Germany
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Düren, North Rhine-Westphalia, 52349, Germany
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Essen, North Rhine-Westphalia, 45355, Germany
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Essen, North Rhine-Westphalia, 45359, Germany
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Gelsenkirchen, North Rhine-Westphalia, 45879, Germany
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Rheine, North Rhine-Westphalia, 48431, Germany
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Warendorf, North Rhine-Westphalia, 48231, Germany
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Koblenz, Rhineland-Palatinate, 56068, Germany
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Annaberg, Saxony, 09456, Germany
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Delitzsch, Saxony, 04509, Germany
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Dresden, Saxony, 01069, Germany
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Leipzg, Saxony, 04109, Germany
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Leipzig, Saxony, 04103, Germany
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Leipzig, Saxony, 04157, Germany
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Leipzig, Saxony, 04275, Germany
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Leipzig, Saxony, 04357, Germany
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Mittweida, Saxony, 09648, Germany
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Teuchern, Saxony-Anhalt, 06682, Germany
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Geesthacht, Schleswig-Holstein, 21502, Germany
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Lübeck, Schleswig-Holstein, 23552, Germany
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Schleswig, Schleswig-Holstein, 24837, Germany
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Schmölln, Thuringia, 04626, Germany
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Berlin, 10117, Germany
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Berlin, 10119, Germany
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Berlin, 10367, Germany
GSK Investigational Site
Berlin, 10625, Germany
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Berlin, 10717, Germany
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Berlin, 10787, Germany
GSK Investigational Site
Berlin, 12627, Germany
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Berlin, 13086, Germany
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Berlin, 13156, Germany
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Berlin, 14059, Germany
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Frankfurt, 60313, Germany
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Hamburg, 20253, Germany
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Hamburg, 22143, Germany
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Hamburg, 22299, Germany
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Leipzig, 04207, Germany
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Cassano Delle Murge (BA), Apulia, 70020, Italy
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Benevento, Campania, 82100, Italy
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Napoli, Campania, 80131, Italy
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Salerno, Campania, 84131, Italy
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San Felice A Cancello (CE), Campania, 81027, Italy
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Reggio Emilia, Emilia-Romagna, 42100, Italy
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Riccione (RN), Emilia-Romagna, 47838, Italy
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Pordenone, Friuli Venezia Giulia, 33170, Italy
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Tradate (VA), Lombardy, 21049, Italy
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Palermo, Sicily, 90146, Italy
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Pisa, Tuscany, 56124, Italy
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San Sisto (PG), Umbria, 06156, Italy
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Napoli, 80131, Italy
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San Pietro Vernotico, 72027, Italy
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Guadalajara, Jalisco, 44100, Mexico
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Zapopan, Jalisco, 45070, Mexico
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Almere Stad, 1311 RL, Netherlands
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Beek, 6191 JW, Netherlands
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Breda, 4818 CK, Netherlands
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Heerlen, 6419 PC, Netherlands
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Hoorn, 1624 NP, Netherlands
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Kloosterhaar, 7694 AC, Netherlands
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Rotterdam, 3067 GJ, Netherlands
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The Hague, 2565 KV, Netherlands
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Zutphen, 7207 AE, Netherlands
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Eloffsdal, Gauteng, 0084, South Africa
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Johannesburg, Gauteng, 2113, South Africa
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Pretoria, Gauteng, 0087, South Africa
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Pretoria, Gauteng, 0121, South Africa
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Middelburg, Mpumalanga, 1050, South Africa
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Bloemfontein, 9301, South Africa
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Cape Town, 7570, South Africa
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Durban, 4001, South Africa
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Mowbray, 7700, South Africa
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Panorama, 7500, South Africa
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Reiger Park, 1459, South Africa
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Marbella - Málaga, Andalusia, 29603, Spain
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Alicante, 03004, Spain
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Barcelona, 08023, Spain
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Barcelona, 08036, Spain
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Centelles (Barcelona), 08540, Spain
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Girona, 17005, Spain
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Mérida (Badajoz), 06800, Spain
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Peralada( Girona), 17491, Spain
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Borås, SE-506 30, Sweden
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Gothenburg, SE-413 45, Sweden
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Gothenburg, SE-413 90, Sweden
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Höllviken, SE-236 51, Sweden
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Linköping, SE-587 58, Sweden
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Luleå, SE-971 89, Sweden
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Lund, SE-221 85, Sweden
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Lund, SE-222 22, Sweden
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Malmo, SE-211 52, Sweden
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Örebro, SE-703 62, Sweden
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Skövde, SE-541 50, Sweden
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Stockholm, 11446, Sweden
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Uppsala, SE-752 37, Sweden
Related Publications (5)
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.
PMID: 31666084BACKGROUNDKerwin EM, Jones PW, Bjermer LH, Maltais F, Boucot IH, Naya IP, Lipson DA, Compton C, Tombs L, Vogelmeier CF. How can the findings of the EMAX trial on long-acting bronchodilation in chronic obstructive pulmonary disease be applied in the primary care setting? Chron Respir Dis. 2023 Jan-Dec;20:14799731231202257. doi: 10.1177/14799731231202257.
PMID: 37800633DERIVEDBjermer LH, Boucot IH, Vogelmeier CF, Maltais F, Jones PW, Tombs L, Compton C, Lipson DA, Kerwin EM. Efficacy and Safety of Umeclidinium/Vilanterol in Current and Former Smokers with COPD: A Prespecified Analysis of The EMAX Trial. Adv Ther. 2021 Sep;38(9):4815-4835. doi: 10.1007/s12325-021-01855-y. Epub 2021 Aug 4.
PMID: 34347255DERIVEDMaltais F, Naya IP, Vogelmeier CF, Boucot IH, Jones PW, Bjermer L, Tombs L, Compton C, Lipson DA, Kerwin EM. Salbutamol use in relation to maintenance bronchodilator efficacy in COPD: a prospective subgroup analysis of the EMAX trial. Respir Res. 2020 Oct 22;21(1):280. doi: 10.1186/s12931-020-01451-8.
PMID: 33092591DERIVEDKerwin EM, Boucot IH, Vogelmeier CF, Maltais F, Naya IP, Tombs L, Jones PW, Lipson DA, Keeley T, Bjermer L. Early and sustained symptom improvement with umeclidinium/vilanterol versus monotherapy in COPD: a post hoc analysis of the EMAX randomised controlled trial. Ther Adv Respir Dis. 2020 Jan-Dec;14:1753466620926949. doi: 10.1177/1753466620926949.
PMID: 32462979DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2017
First Posted
January 27, 2017
Study Start
June 16, 2017
Primary Completion
June 18, 2018
Study Completion
June 18, 2018
Last Updated
March 11, 2020
Results First Posted
July 15, 2019
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- IPD is available via the Clinical Study Data Request site (click on the link provided below)
- Access Criteria
- Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD for this study will be made available via the Clinical Study Data Request site.