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Pulmonary Disease, Chronic ObstructivePhase 4NCT02236611

A 12-week Study to Evaluate the Efficacy and Safety of Umeclidinium 62.5 Microgram (mcg) Compared With Glycopyrronium 44 mcg in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

A Phase 4 study testing Umeclidinium and Glycopyrronium in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 94 sites in 10 countries.

Completed

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

Official record
Search all trials

Trial summary

This is a 12-week, multicentre, randomized, open-label, 2-arm, parallel-group study designed to compare the efficacy and safety of umeclidinium inhalation powder (62.5 mcg once daily [QD]) administered via a novel Dry Powder Inhaler (nDPI) with glycopyrronium (44 mcg QD) administered via a Breezhaler® inhaler in… 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?
Umeclidinium and Glycopyrronium
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,036 participants
Where
94 sitesin 10 countries
Study dates
26 Sep 2014to 2 Jun 2015
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

  • Type of subject: outpatient
  • Informed Consent: a signed and dated written informed consent prior to study participation
  • Age: subjects 40 years of age or older at Visit 1.
  • Gender: male and female subjects are eligible to participate in the study. A female is eligible to enter and participate in the study if she is of: Non-child bearing potential i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile. Surgically sterile females are defined as those with a documented hysterectomy and/or bilateral oophorectomy or tubal ligation. Post-menopausal females are defined as being amenorrhoeic for greater than 1 year with an appropriate clinical profile, eg, age appropriate, > 45 years, in the absence of hormone replacement therapy OR child bearing potential, has a negative pregnancy test at screening, and agrees to one of the acceptable contraceptive methods used consistently and correctly i.e., in accordance with the approved product label and the instructions of the physician for the duration of the study - screening to follow-up contact.
  • Diagnosis: an established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society (ERS)
  • Smoking history: 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) x number of years smoked (eg. 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
  • Severity of Disease: A pre and post-albuterol/salbutamol forced expiratory volume in one second/ forced vital capacity (FEV1/FVC ratio of <0.70 and a post-albuterol/salbutamol FEV1 of >=30% and =<70% of predicted normal values at Visit 1. Predicted values will be based upon the ERS Global Lung Function Initiative
  • Dyspnea: A score of >=2 on the modified medical research council dyspnea scale (mMRC) at Visit 1

Who cannot join

  • Pregnancy: women who are pregnant or lactating or are planning on becoming pregnant during the study.
  • Asthma: a current diagnosis of asthma.
  • Other respiratory disorders: known alpha-1 antitrypsin deficiency, active lung infections (such as tuberculosis), and lung cancer are absolute exclusionary conditions. A subject who, in the opinion of the investigator, has any other significant respiratory conditions in addition to COPD should be excluded. Examples may include clinically significant bronchiectasis, pulmonary hypertension, sarcoidosis, or interstitial lung disease.
  • Other diseases/abnormalities: 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 condition (e.g. neurological condition) that is likely to affect respiratory function should not be included in the study.
  • Severe hepatic impairment: patients with severe hepatic impairment (Child-Pugh class C) should be excluded unless, in the opinion of the investigator, the benefit is likely to outweigh the risk.
  • Severe renal impairment: patients with severe renal impairment (e.g., end-stage renal disease requiring dialysis) should be excluded, unless in the opinion of the investigator, the benefit is likely to outweigh the risk.
Show all 20Show fewer
  • Unstable or life threatening cardiac disease: long-acting muscarinic antagonists (LAMA) should be used with caution in subjects with severe cardiovascular disease. In the opinion of the investigator, use should 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, Unstable or life threatening cardiac arrhythmia requiring intervention in the last 3 months, New York Heart Association (NYHA) Class IV heart failure
  • Contraindications: Any history of allergy or hypersensitivity to any anticholinergic/ muscarinic receptor antagonist, sympathomimetic, lactose/milk protein or magnesium stearate.
  • Antimuscarinic effects: Subjects with medical conditions such as narrow-angle glaucoma, urinary retention, prostatic hypertrophy, or bladder neck obstruction should only be included if, in the opinion of the study physician, the benefit outweighs the risk.
  • Hospitalization: hospitalization for COPD or pneumonia within 12 weeks prior to Visit 1.
  • Lung resection: lung volume reduction surgery within the 12 months prior to Visit 1.
  • 12-Lead electrocardiogram (ECG): Investigators will be provided with ECG reviews conducted by a centralized independent cardiologist to assist in evaluation of subject eligibility. The Investigator will determine the clinical significance of each abnormal 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; sustained or nonsustained ventricular tachycardia; second degree heart block Mobitz type II or third degree heart block (unless pacemaker or defibrillator had been inserted)
  • Medication prior to spirometry: unable to withhold albuterol/salbutamol for the 4 hour period required prior to spirometry testing at each study visit.
  • Medications prior to screening: use of the following medications according to the following defined time intervals prior to Visit 1: depot corticosteroids 12 weeks, systemic, oral or parenteral corticosteroids 6 weeks, antibiotics (for lower respiratory tract infection) 6 weeks, inhaled long acting beta2 agonists/ inhaled corticosteroid (LABA/ICS) combination products if LABA/ICS therapy is discontinued completely 30 days; LABA/ICS combination products only If discontinuing ICS/ LABA therapy and switching to ICS monotherapy 48 hours for the salmeterol or formoterol component 14 days for the vilanterol component (note: the dose of ICS must be a dose of fluticasone propionate (FP) or equivalent but not to exceed 1000 mcg/day), use of ICS at a dose >1000 microgram (mcg)/day of FP or equivalent 30 days (note: use of ICS is permitted provided the dose does not exceed 1000 mcg of FP or equivalent; ICS use not to be initiated or discontinued within 30 days prior to Visit 1, except for subjects on LABA/ICS therapy who may discontinue the ICS/LABA product as indicated in the table above and switch to ICS monotherapy); initiation or discontinuation of ICS use 30 days (note: use of ICS is permitted provided the dose does not exceed 1000 mcg of FP or equivalent; ICS use not to be initiated or discontinued within 30 days prior to Visit 1, except for subjects on LABA/ICS therapy who may discontinue the ICS/LABA product as indicated in the table above and switch to ICS monotherapy); phosphodiesterase 4 (PDE4) Inhibitor (roflumilast) 14 days; LABA: salmeterol and formoterol 48 hours; olodaterol, indacaterol, and vilanterol 14 days; LAMA: tiotropium, aclidinium, glycopyrronium, umeclidinium 7 days; LAMA/LABA combination products if LAMA/LABA therapy is discontinued completely then apply whichever mono component has the longest washout; theophyllines 48 hours; Oral beta2-agonists: long-acting 48 hours, short-acting 12 hours; inhaled short acting beta2-agonists 4 hours (note: use of study provided albuterol/salbutamol is permitted during the study, except in the 4-hour period prior to spirometry testing); inhaled short-acting anticholinergics 4 hours; inhaled short-acting anticholinergic/short-acting beta2-agonist combination products 4 hours; any other investigational medication 30 days or within 5 drug half-lives (whichever is longer).
  • Oxygen: use of long-term oxygen therapy (LTOT) described as oxygen therapy prescribed for greater than 12 hours a day. As-needed oxygen use (i.e. =<12 hours per day) is not exclusionary.
  • Nebulized therapy: regular use (prescribed for use every day, not for as-needed use) of short-acting bronchodilators (e.g. albuterol/salbutamol) via nebulized therapy.
  • Pulmonary rehabilitation program: participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1. Subjects who are in the maintenance phase of a pulmonary rehabilitation program are not excluded.
  • Drug or alcohol abuse: A known or suspected history of alcohol or drug abuse within 2 years prior to Visit 1.
  • Affiliation with investigator site: 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.
  • Inability to read: in the opinion of the investigator, any subject who is unable to read and/or would not be able to complete a questionnaire

Trial locations and contacts

94 sites in 10 countries.

94 sites in 10 countries

Russia25 sites

  • GSK Investigational Site

    Barnaul, 656024

  • GSK Investigational Site

    Barnaul, 656038

  • GSK Investigational Site

    Chelyabinsk, 454076

  • GSK Investigational Site

    Chelyabinsk, 454091

  • GSK Investigational Site

    Chelyabinsk, 454106

  • GSK Investigational Site

    Chita, 672000

  • GSK Investigational Site

    Irkutsk, 664005

  • GSK Investigational Site

    Ivanovo, 153005

  • GSK Investigational Site

    Kazan', 420012

  • GSK Investigational Site

    Kemerovo, 650000

  • GSK Investigational Site

    Moscow, 105 077

  • GSK Investigational Site

    Moscow, 119620

  • GSK Investigational Site

    Moscow, 125315

  • GSK Investigational Site

    Nizhny Novgorod, 603126

  • GSK Investigational Site

    Novosibirsk

  • GSK Investigational Site

    Perm, 614097

  • GSK Investigational Site

    Ryazan, 390026

  • GSK Investigational Site

    Saint Petersburg, 194044

  • GSK Investigational Site

    Saint Petersburg, 194354

  • GSK Investigational Site

    Saint Petersburg, 194356

  • GSK Investigational Site

    Saint Petersburg, 195271

  • GSK Investigational Site

    Saint Petersburg, 198216

  • GSK Investigational Site

    Saint Petesburg, 195030

  • GSK Investigational Site

    Stavropol, 355017

  • GSK Investigational Site

    Yekaterinburg, 620109

Other trials in Russia

Germany14 sites

  • GSK Investigational Site

    Bamberg, Bavaria, 96049

  • GSK Investigational Site

    Brinkum/Stuhr, Lower Saxony, 28816

  • GSK Investigational Site

    Düren, North Rhine-Westphalia, 52349

  • GSK Investigational Site

    Essen, North Rhine-Westphalia, 45359

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60596

  • GSK Investigational Site

    Gelsenkirchen, North Rhine-Westphalia, 45879

  • GSK Investigational Site

    Hanover, Lower Saxony, 30167

  • GSK Investigational Site

    Hanover, Lower Saxony, 30173

  • GSK Investigational Site

    Koblenz, Rhineland-Palatinate, 56068

  • GSK Investigational Site

    Leipzig, Saxony, 04103

  • GSK Investigational Site

    Leipzig, Saxony, 04275

  • GSK Investigational Site

    Leipzig, Saxony, 04357

  • GSK Investigational Site

    Lübeck, Schleswig-Holstein, 23552

  • GSK Investigational Site

    Munich, Bavaria, 80539

Other trials in Germany

Argentina8 sites

  • GSK Investigational Site

    Concepción del Uruguay, Entre Ríos Province, 3260

  • GSK Investigational Site

    Mendoza, 5500

  • GSK Investigational Site

    Mendoza, M5500CCG

  • GSK Investigational Site

    Paraná, Buenos Aires, E3100BHK

  • GSK Investigational Site

    Rosario, Santa Fe Province, S2000JKR

  • GSK Investigational Site

    San Miguel de Tucumán, 4000

  • GSK Investigational Site

    San Miguel de Tucumán, T4000IFL

  • GSK Investigational Site

    San Rafael, Mendoza Province, 5600

Other trials in Argentina

Chile8 sites

  • GSK Investigational Site

    Concepción, Región Del Biobio, 4070038

  • GSK Investigational Site

    Puente Alto - Santiago, Región Metro de Santiago, 8207257

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 7500710

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 7510186

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 8242238

  • GSK Investigational Site

    Santiago, 7500698

  • GSK Investigational Site

    Santiago, 8380453

  • GSK Investigational Site

    Talca, Maule Region, 3465584

Other trials in Chile

Czechia7 sites

  • GSK Investigational Site

    Jindřichův Hradec, 377 01

  • GSK Investigational Site

    Kralupy nad Vltavou, 278 01

  • GSK Investigational Site

    Lovosice, 410 02

  • GSK Investigational Site

    Ostrava - Poruba, 70868

  • GSK Investigational Site

    Rudna U Prahy, 252 19

  • GSK Investigational Site

    Třebíč, 674 01

  • GSK Investigational Site

    Varnsdorf, 407 47

Other trials in Czechia

Hungary7 sites

  • GSK Investigational Site

    Balassagyarmat, 2660

  • GSK Investigational Site

    Budapest, 1085

  • GSK Investigational Site

    Debrecen, 4032

  • GSK Investigational Site

    Debrecen, 4043

  • GSK Investigational Site

    Kapuvár, 9330

  • GSK Investigational Site

    Nagykanizsa, 8800

  • GSK Investigational Site

    Törökbálint, 2045

Other trials in Hungary

Norway7 sites

  • GSK Investigational Site

    Ålesund, 6017

  • GSK Investigational Site

    Hakadal, 1487

  • GSK Investigational Site

    Hamar, 2317

  • GSK Investigational Site

    Hønefoss, N-3515

  • GSK Investigational Site

    Kolbjørnsvik, 4816

  • GSK Investigational Site

    Kongsvinger, N-2200

  • GSK Investigational Site

    Løvenstad, 2006

Other trials in Norway

Romania7 sites

  • GSK Investigational Site

    Brasov, 500283

  • GSK Investigational Site

    Bucharest, 020125

  • GSK Investigational Site

    Cluj-Napoca, 400371

  • GSK Investigational Site

    Iași, 700115

  • GSK Investigational Site

    Râmnicu Vâlcea, 240564

  • GSK Investigational Site

    Suceava, 720284

  • GSK Investigational Site

    Timișoara, 300310

Other trials in Romania

Spain7 sites

  • GSK Investigational Site

    Barcelona, 08017

  • GSK Investigational Site

    Barcelona, 08023

  • GSK Investigational Site

    Barcelona, 08028

  • GSK Investigational Site

    Fuenlabrada / Madrid, 28943

  • GSK Investigational Site

    La Roca Del Valles (Barcelona), 08430

  • GSK Investigational Site

    Laredo, Cantabria, 39770

  • GSK Investigational Site

    Peralada( Girona), 17491

Other trials in Spain

Sweden4 sites

  • GSK Investigational Site

    Gothenburg, SE-413 45

  • GSK Investigational Site

    Gothenburg, SE-413 90

  • GSK Investigational Site

    Stockholm, SE-111 57

  • GSK Investigational Site

    Stockholm, SE-113 61

Other trials in Sweden

About this study

Official title: A Randomized, Parallel-group, Open-label Study to Evaluate the Efficacy and Safety of Umeclidinium (UMEC) 62.5 mcg Compared With Glycopyrronium 44 mcg in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

This is a 12-week, multicentre, randomized, open-label, 2-arm, parallel-group study designed to compare the efficacy and safety of umeclidinium inhalation powder (62.5 mcg once daily [QD]) administered via a novel Dry Powder Inhaler (nDPI) with glycopyrronium (44 mcg QD) administered via a Breezhaler® inhaler in subjects with COPD over 12 weeks of treatment. At the end of the run-in period, eligible subjects will be randomized in a 1:1 ratio to receive umeclidinium 62.5 mcg administered via nDPI or glycopyrronium 44 mcg administered via BREEZHALER inhaler. There will be up to 8 clinic visits conducted on an outpatient basis at Pre-Screening (Visit 0), Screening (Visit 1), Randomization at Day 1 (Visit 2), and after Randomization at Day 2 (Visit 3), Day 28 (Visit 4), Day 56 (Visit 5), Day 84 (Visit 6) and Day 85 (Visit 7). The total duration of subject participation in the study will be approximately 15 weeks. The primary endpoint of the study is clinic visit trough FEV1 (forced expiratory volume in one second) on treatment Day 85. All subjects will have spirometry performed at clinic Visits 1 though 7. Trough spirometry will be obtained 23 and 24 hours after the previous day's dose of open-label study medication at Visits 3 to 7.

BREEZHALER is a registered trademark of Novartis AG.

Being tested
Umeclidinium, Glycopyrronium
Keywords
COPD, inhaler ease of use, glycopyrronium, umeclidinium, novel dry powder inhaler, long-acting muscarinic antagonist, inhaler errors
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.

  • UmeclidiniumDrug

    Umeclidinium 62.5 mcg will be available as dry inhalation powder to be taken using a nDPI

  • GlycopyrroniumDrug

    Glycopyrronium bromide will be available as inhalation capsules, 44 mcg per capsule, taken using BREEZHALER inhalers

Study groups in NCT02236611
Study groupRoleWhat they receive
Umeclidinium 62.5 mcgExperimentalRandomized subjects will receive umeclidinium inhalation powder 62.5 mcg, once daily over a period of 12 weeks via a nDPI. Subjects will be instructed to take one dose each morning.
Receives: Drug: Umeclidinium
Glycopyrronium 44 mcgExperimentalRandomized subjects will receive glycopyrronium 44 mcg, once daily over a period of 12 weeks via a BREEZHALER inhaler. Subjects will be instructed to take one dose each morning.
Receives: Drug: Glycopyrronium

What is being measured

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

  1. Change From Baseline in Trough FEV1 on Day 85

    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 on Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Day 84 (Week 12). Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84 and 85. Baseline trough FEV1 is the mean of the two assessments made -30 and -5 minutes (min) pre-dose on Day 1. Change from baseline was calculated as the trough FEV1 value on Day 85 minus the BL value. Analysis performed using a repeated measures model with covariates of treatment, baseline FEV1, centre group, 24 hour subset flag, Day, Day by baseline and Day by treatment interactions. The least squares mean changes are presented here.

    Measured: Baseline (BL) and Day 85

Timeline

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

  1. First posted10 Sep 2014 (estimated)
  2. Study start26 Sep 2014
  3. Primary completion2 Jun 2015
  4. Study completion2 Jun 2015

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
None (open label)
Enrolment
1,036 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02236611
Sponsor's protocol ID
201315
Status last verified
Apr 2018
First submitted
8 Sep 2014
Last updated
2 May 2018
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • Shah D, Driessen M, Risebrough N, Baker T, Naya I, Briggs A, Ismaila AS. Cost-effectiveness of umeclidinium compared with tiotropium and glycopyrronium as monotherapy for chronic obstructive pulmonary disease: a UK perspective. Cost Eff Resour Alloc. 2018 May 10;16:17. doi: 10.1186/s12962-018-0101-3. eCollection 2018.

    PubMed 29773969

  • Rheault T, Khindri S, Vahdati-Bolouri M, Church A, Fahy WA. A randomised, open-label study of umeclidinium versus glycopyrronium in patients with COPD. ERJ Open Res. 2016 Apr 27;2(2):00101-2015. doi: 10.1183/23120541.00101-2015. eCollection 2016 Apr.

    PubMed 27730198

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Umeclidinium and Glycopyrronium in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 94 sites in 10 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 20 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 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 94 sites in Russia, Germany, Argentina, Chile, Czechia and 5 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 Feb 2016). 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 FEV1 on Day 85 (time frame: Baseline (BL) and Day 85). 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 NCT02236611, which also lists 2 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 2 May 2018.

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