AzTrials
AzTrials

Pulmonary Disease, Chronic ObstructivePhase 4NCT03034915

A 24-week Study to Compare Umeclidinium/Vilanterol (UMEC/VI), UMEC and Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

A Phase 4 study testing UMEC/VI 62.5/25 mcg via ELLIPTA, UMEC 62.5 mcg via ELLIPTA and Salmeterol 50 mcg via DISKUS in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 212 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
UMEC/VI 62.5/25 mcg via ELLIPTA, UMEC 62.5 mcg via ELLIPTA and Salmeterol 50 mcg via DISKUS
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,696 participants
Where
212 sitesin 12 countries
Study dates
16 Jun 2017to 18 Jun 2018
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

212 sites in 12 countries.

212 sites in 12 countries

Germany64 sites

  • GSK Investigational Site

    Annaberg, Saxony, 09456

  • GSK Investigational Site

    Bamberg, Bavaria, 96049

  • GSK Investigational Site

    Bergisch Gladbach, North Rhine-Westphalia, 51429

  • GSK Investigational Site

    Berlin, 10117

  • GSK Investigational Site

    Berlin, 10119

  • GSK Investigational Site

    Berlin, 10367

  • GSK Investigational Site

    Berlin, 10625

  • GSK Investigational Site

    Berlin, 10717

  • GSK Investigational Site

    Berlin, 10787

  • GSK Investigational Site

    Berlin, 12627

  • GSK Investigational Site

    Berlin, 13086

  • GSK Investigational Site

    Berlin, 13156

  • GSK Investigational Site

    Berlin, 14059

  • GSK Investigational Site

    Bochum, North Rhine-Westphalia, 44787

  • GSK Investigational Site

    Bonn, North Rhine-Westphalia, 53119

  • GSK Investigational Site

    Bonn, North Rhine-Westphalia, 53123

  • GSK Investigational Site

    Cologne, North Rhine-Westphalia, 51069

  • GSK Investigational Site

    Darmstadt, Hesse, 64283

  • GSK Investigational Site

    Delitzsch, Saxony, 04509

  • GSK Investigational Site

    Dortmund, North Rhine-Westphalia, 44263

  • GSK Investigational Site

    Dresden, Saxony, 01069

  • GSK Investigational Site

    Düren, North Rhine-Westphalia, 52349

  • GSK Investigational Site

    Erlangen, Bavaria, 91052

  • GSK Investigational Site

    Essen, North Rhine-Westphalia, 45355

  • GSK Investigational Site

    Essen, North Rhine-Westphalia, 45359

  • GSK Investigational Site

    Frankfurt, 60313

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60389

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60596

  • GSK Investigational Site

    Fulda, Hesse, 36039

  • GSK Investigational Site

    Geesthacht, Schleswig-Holstein, 21502

  • GSK Investigational Site

    Gelsenkirchen, North Rhine-Westphalia, 45879

  • GSK Investigational Site

    Hamburg, 20253

  • GSK Investigational Site

    Hamburg, 22143

  • GSK Investigational Site

    Hamburg, 22299

  • GSK Investigational Site

    Hanover, Lower Saxony, 30159

  • GSK Investigational Site

    Hanover, Lower Saxony, 30167

  • GSK Investigational Site

    Hanover, Lower Saxony, 30173

  • GSK Investigational Site

    Karlsruhe, Baden-Wurttemberg, 76137

  • GSK Investigational Site

    Kassel, Hesse, 34121

  • GSK Investigational Site

    Koblenz, Rhineland-Palatinate, 56068

  • GSK Investigational Site

    Leipzg, Saxony, 04109

  • GSK Investigational Site

    Leipzig, Saxony, 04103

  • GSK Investigational Site

    Leipzig, Saxony, 04157

  • GSK Investigational Site

    Leipzig, Saxony, 04275

  • GSK Investigational Site

    Leipzig, Saxony, 04357

  • GSK Investigational Site

    Leipzig, 04207

  • GSK Investigational Site

    Lübeck, Schleswig-Holstein, 23552

  • GSK Investigational Site

    Marburg, Hesse, 35037

  • GSK Investigational Site

    Mittweida, Saxony, 09648

  • GSK Investigational Site

    Munich, Bavaria, 80339

  • GSK Investigational Site

    Munich, Bavaria, 81241

  • GSK Investigational Site

    Neu-Isenburg, Hesse, 63263

  • GSK Investigational Site

    Osnabrück, Lower Saxony, 49074

  • GSK Investigational Site

    Peine, Lower Saxony, 31224

  • GSK Investigational Site

    Potsdam, Brandenburg, 14469

  • GSK Investigational Site

    Rheine, North Rhine-Westphalia, 48431

  • GSK Investigational Site

    Rüdersdorf, Brandenburg, 15562

  • GSK Investigational Site

    Schleswig, Schleswig-Holstein, 24837

  • GSK Investigational Site

    Schmölln, Thuringia, 04626

  • GSK Investigational Site

    Schwerin, Mecklenburg-Vorpommern, 19055

  • GSK Investigational Site

    Teuchern, Saxony-Anhalt, 06682

  • GSK Investigational Site

    Wardenburg, Lower Saxony, 26203

  • GSK Investigational Site

    Warendorf, North Rhine-Westphalia, 48231

  • GSK Investigational Site

    Wiesloch, Baden-Wurttemberg, 69168

Other trials in Germany

United States37 sites

  • GSK Investigational Site

    Abingdon, Virginia, 24210

  • GSK Investigational Site

    Albuquerque, New Mexico, 87108

  • GSK Investigational Site

    Anderson, South Carolina, 29621

  • GSK Investigational Site

    Charleston, South Carolina, 29406-7108

  • GSK Investigational Site

    Charlotte, North Carolina, 28207

  • GSK Investigational Site

    Chesterfield, Missouri, 63017

  • GSK Investigational Site

    Cincinnati, Ohio, 45231

  • GSK Investigational Site

    Clearwater, Florida, 33765

  • GSK Investigational Site

    Easley, South Carolina, 29640

  • GSK Investigational Site

    Edina, Minnesota, 55435

  • GSK Investigational Site

    Fridley, Minnesota, 55432

  • GSK Investigational Site

    Gaffney, South Carolina, 29340

  • GSK Investigational Site

    Gastonia, North Carolina, 28054

  • GSK Investigational Site

    Greenville, South Carolina, 29615

  • GSK Investigational Site

    Lancaster, South Carolina, 29720

  • GSK Investigational Site

    Lincoln, California, 95648

  • GSK Investigational Site

    Medford, Oregon, 97504

  • GSK Investigational Site

    Minneapolis, Minnesota, 55407

  • GSK Investigational Site

    Monroe, North Carolina, 28112

  • GSK Investigational Site

    Mooresville, North Carolina, 28117

  • GSK Investigational Site

    Morgantown, West Virginia, 26505

  • GSK Investigational Site

    Mt. Pleasant, South Carolina, 29464

  • GSK Investigational Site

    Natchitoches, Louisiana, 71457

  • GSK Investigational Site

    O'Fallon, Illinois, 62269

  • GSK Investigational Site

    Omaha, Nebraska, 68134

  • GSK Investigational Site

    Orlando, Florida, 32825

  • GSK Investigational Site

    Phoenix, Arizona, 85018

  • GSK Investigational Site

    Rock Hill, South Carolina, 29732

  • GSK Investigational Site

    Saint Charles, Missouri, 63301

  • GSK Investigational Site

    Seneca, South Carolina, 29678

  • GSK Investigational Site

    Sherman, Texas, 75092

  • GSK Investigational Site

    Spartanburg, South Carolina, 29303

  • GSK Investigational Site

    St Louis, Missouri, 63141

  • GSK Investigational Site

    Tampa, Florida, 33603

  • GSK Investigational Site

    Union, South Carolina, 29379

  • GSK Investigational Site

    Winston-Salem, North Carolina, 27103

  • GSK Investigational Site

    Woodbury, Minnesota, 55125

Other trials in United States

Argentina32 sites

  • GSK Investigational Site

    Buenos Aires, C1120AAC

  • GSK Investigational Site

    Buenos Aires, C1121ABE

  • GSK Investigational Site

    Buenos Aires, C1128AAF

  • GSK Investigational Site

    Buenos Aires, C1424BSF

  • GSK Investigational Site

    Buenos Aires, C1425BEN

  • GSK Investigational Site

    Buenos Aires, C1426ABP

  • GSK Investigational Site

    Capital Federal, C1440BRR

  • GSK Investigational Site

    Ciudad Autonoma de Buenis Aires, C1015ABR

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1028AAP

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1414AIF

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1425AGC

  • GSK Investigational Site

    Concepción del Uruguay, Entre Ríos Province, 3260

  • GSK Investigational Site

    Córdoba, Córdoba Province, X5003DCE

  • GSK Investigational Site

    Florida, Buenos Aires, 1602

  • GSK Investigational Site

    La Plata, Buenos Aires

  • GSK Investigational Site

    Lobos, Buenos Aires, 7240

  • GSK Investigational Site

    Mar del Plata, Buenos Aires, 7600

  • GSK Investigational Site

    Mar del Plata, Buenos Aires, B7600FZN

  • GSK Investigational Site

    Mendoza, 5500

  • GSK Investigational Site

    Mendoza, 5501

  • GSK Investigational Site

    Mendoza, M5500CCG

  • GSK Investigational Site

    Monte Grande, 1842

  • GSK Investigational Site

    Paraná, Buenos Aires, E3100BHK

  • GSK Investigational Site

    Quilmes, Buenos Aires, B1878FNR

  • GSK Investigational Site

    Rosario, Santa Fe Province, 2000

  • GSK Investigational Site

    Rosario, Santa Fe Province, S2002OJN

  • GSK Investigational Site

    San Miguel de Tucumán, 4000

  • GSK Investigational Site

    San Miguel de Tucumán, T4000DGF

  • GSK Investigational Site

    San Rafael, Mendoza Province, 5600

  • GSK Investigational Site

    Santa Fe, 3000

  • GSK Investigational Site

    Santa Rosa, 6300

  • GSK Investigational Site

    Vicente López, Buenos Aires, B1602DOH

Other trials in Argentina

Italy14 sites

  • GSK Investigational Site

    Benevento, Campania, 82100

  • GSK Investigational Site

    Cassano Delle Murge (BA), Apulia, 70020

  • GSK Investigational Site

    Naples, Campania, 80131

  • GSK Investigational Site

    Naples, 80131

  • GSK Investigational Site

    Palermo, Sicily, 90146

  • GSK Investigational Site

    Pisa, Tuscany, 56124

  • GSK Investigational Site

    Pordenone, Friuli Venezia Giulia, 33170

  • GSK Investigational Site

    Reggio Emilia, Emilia-Romagna, 42100

  • GSK Investigational Site

    Riccione (RN), Emilia-Romagna, 47838

  • GSK Investigational Site

    Salerno, Campania, 84131

  • GSK Investigational Site

    San Felice A Cancello (CE), Campania, 81027

  • GSK Investigational Site

    San Pietro Vernotico, 72027

  • GSK Investigational Site

    San Sisto (PG), Umbria, 06156

  • GSK Investigational Site

    Tradate (VA), Lombardy, 21049

Other trials in Italy

Canada13 sites

  • GSK Investigational Site

    Gatineau, Quebec, J8Y 6S8

  • GSK Investigational Site

    Hamilton, Ontario, L8L 5G8

  • GSK Investigational Site

    London, Ontario, N5W 6A2

  • GSK Investigational Site

    Mirabel, Quebec, J7J 2K8

  • GSK Investigational Site

    Moncton, New Brunswick, E1G1A7

  • GSK Investigational Site

    Montreal, Quebec, H1M 1B1

  • GSK Investigational Site

    Québec, Quebec, G1V 4G5

  • GSK Investigational Site

    Québec, Quebec, G1W 4R4

  • GSK Investigational Site

    Saint-Charles-Borromée, Quebec, J6E 2B4

  • GSK Investigational Site

    Sarnia, Ontario, N7T 4X3

  • GSK Investigational Site

    Toronto, Ontario, M9V 4B4

  • GSK Investigational Site

    Truro, Nova Scotia, B2N 1L2

  • GSK Investigational Site

    Windsor, Ontario, N8X 1T3

Other trials in Canada

Sweden13 sites

  • GSK Investigational Site

    Borås, SE-506 30

  • GSK Investigational Site

    Gothenburg, SE-413 45

  • GSK Investigational Site

    Gothenburg, SE-413 90

  • GSK Investigational Site

    Höllviken, SE-236 51

  • GSK Investigational Site

    Linköping, SE-587 58

  • GSK Investigational Site

    Luleå, SE-971 89

  • GSK Investigational Site

    Lund, SE-221 85

  • GSK Investigational Site

    Lund, SE-222 22

  • GSK Investigational Site

    Malmö, SE-211 52

  • GSK Investigational Site

    Örebro, SE-703 62

  • GSK Investigational Site

    Skövde, SE-541 50

  • GSK Investigational Site

    Stockholm, 11446

  • GSK Investigational Site

    Uppsala, SE-752 37

Other trials in Sweden

South Africa11 sites

  • GSK Investigational Site

    Bloemfontein, 9301

  • GSK Investigational Site

    Cape Town, 7570

  • GSK Investigational Site

    Durban, 4001

  • GSK Investigational Site

    Eloffsdal, Gauteng, 0084

  • GSK Investigational Site

    Johannesburg, Gauteng, 2113

  • GSK Investigational Site

    Middelburg, Mpumalanga, 1050

  • GSK Investigational Site

    Mowbray, 7700

  • GSK Investigational Site

    Panorama, 7500

  • GSK Investigational Site

    Pretoria, Gauteng, 0087

  • GSK Investigational Site

    Pretoria, Gauteng, 0121

  • GSK Investigational Site

    Reiger Park, 1459

Other trials in South Africa

Netherlands9 sites

  • GSK Investigational Site

    Almere Stad, 1311 RL

  • GSK Investigational Site

    Beek, 6191 JW

  • GSK Investigational Site

    Breda, 4818 CK

  • GSK Investigational Site

    Heerlen, 6419 PC

  • GSK Investigational Site

    Hoorn, 1624 NP

  • GSK Investigational Site

    Kloosterhaar, 7694 AC

  • GSK Investigational Site

    Rotterdam, 3067 GJ

  • GSK Investigational Site

    The Hague, 2565 KV

  • GSK Investigational Site

    Zutphen, 7207 AE

Other trials in Netherlands

Spain8 sites

  • GSK Investigational Site

    Alicante, 03004

  • GSK Investigational Site

    Barcelona, 08023

  • GSK Investigational Site

    Barcelona, 08036

  • GSK Investigational Site

    Centelles (Barcelona), 08540

  • GSK Investigational Site

    Girona, 17005

  • GSK Investigational Site

    Marbella - Málaga, Andalusia, 29603

  • GSK Investigational Site

    Mérida (Badajoz), 06800

  • GSK Investigational Site

    Peralada( Girona), 17491

Other trials in Spain

Australia5 sites

  • GSK Investigational Site

    Coffs Harbour, New South Wales, 2450

  • GSK Investigational Site

    Darlinghurst, Sydney, New South Wales, 2010

  • GSK Investigational Site

    Kanwal, New South Wales, 2259

  • GSK Investigational Site

    Port Macquarie, New South Wales, 2444

  • GSK Investigational Site

    Sydney, New South Wales, 2010

Other trials in Australia

France4 sites

  • GSK Investigational Site

    Marseille, 13331

  • GSK Investigational Site

    Nice, 06000

  • GSK Investigational Site

    Perpignan, 66000

  • GSK Investigational Site

    Pessac, 33604

Other trials in France

Mexico2 sites

  • GSK Investigational Site

    Guadalajara, Jalisco, 44100

  • GSK Investigational Site

    Zapopan, Jalisco, 45070

Other trials in Mexico

About this study

Official 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)

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.

Read more

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.

Being tested
UMEC/VI 62.5/25 mcg via ELLIPTA, UMEC 62.5 mcg via ELLIPTA, Salmeterol 50 mcg via DISKUS, Placebo via ELLIPTA, Placebo via DISKUS
Keywords
Vilanterol, COPD, HRQoL, Salmeterol, Umeclidinium
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UMEC/VI 62.5/25 mcg via ELLIPTADrug

    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.

  • UMEC 62.5 mcg via ELLIPTADrug

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

  • Salmeterol 50 mcg via DISKUSDrug

    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.

  • Placebo via ELLIPTADrug

    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.

  • Placebo via DISKUSDrug

    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.

Study groups in NCT03034915
Study groupRoleWhat they receive
UMEC/VI 62.5/25 mcg via ELLIPTA + placebo via DISKUSExperimentalSubjects 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.
Receives: Drug: UMEC/VI 62.5/25 mcg via ELLIPTA; Drug: Placebo via DISKUS
UMEC 62.5 mcg via ELLIPTA + placebo via DISKUSExperimentalSubjects 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.
Receives: Drug: UMEC 62.5 mcg via ELLIPTA; Drug: Placebo via DISKUS
Salmeterol 50 mcg via DISKUS + placebo via ELLIPTAExperimentalSubjects 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.
Receives: Drug: Salmeterol 50 mcg via DISKUS; Drug: Placebo via ELLIPTA

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (10)

  1. 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.

    Measured: Week 24

  2. 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.

    Measured: Week 24

  3. 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.

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

  4. Mean Change From Baseline in E-RS Subscale 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.

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

  5. 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.

    Measured: Week 21 to Week 24

  6. 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.

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

  7. 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.

    Measured: Week 24

  8. 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.

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

  9. 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.

    Measured: Week 24

  10. 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.

    Measured: Up to Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2017 (estimated)
  2. Study start16 Jun 2017
  3. Primary completion18 Jun 2018
  4. Study completion18 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
2,696 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03034915
Sponsor's protocol ID
201749
Other IDs
2016-002513-22, 2016
Status last verified
Mar 2020
First submitted
25 Jan 2017
Last updated
11 Mar 2020
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: IPD for this study will be made available via the Clinical Study Data Request site.

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.

    PubMed 31666084

  • Kerwin 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.

    PubMed 37800633

  • Bjermer 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.

    PubMed 34347255

  • Maltais 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.

    PubMed 33092591

  • Kerwin 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.

    PubMed 32462979

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing UMEC/VI 62.5/25 mcg via ELLIPTA, UMEC 62.5 mcg via ELLIPTA and Salmeterol 50 mcg via DISKUS in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 212 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 212 sites in Germany, United States, Argentina, Italy, Canada and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Week 24 (time frame: Baseline (Pre-dose on Day 1) and Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03034915, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2020.

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