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Pulmonary Disease, Chronic ObstructivePhase 3NCT01316913

24-week Trial Comparing GSK573719/GW642444 With GSK573719 and With Tiotropium in Chronic Obstructive Pulmonary Disease

A Phase 3 study testing GSK573719/GW642444 125/25, GSK573719/GW642444 62.5/25 and GSK573719 in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 100 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 Phase III multicenter, randomized, double-blind, double-dummy, parallel-group study to evaluate the efficacy and safety of two doses of GSK573719/GW642444 Inhalation Powder, GSK573719 Inhalation Powder via a Novel Dry Powder Inhaler and tiotropium via HandiHaler when administered once-daily over a 24-week… 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?
GSK573719/GW642444 125/25, GSK573719/GW642444 62.5/25 and GSK573719
Could I receive a placebo?
No, everyone receives an active treatment
How many people
872 participants
Where
100 sitesin 10 countries
Study dates
Mar 2011to Apr 2012
Phase
Phase 3
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

  • outpatient
  • signed and dated written informed consent
  • 40 years of age or older
  • male and female subjects
  • COPD diagnosis
  • at least 10 pack-year smoking history
  • post-albuterol/salbutamol FEV1/FVC ratio of <0.70 and post-albuterol/salbutamol FEV1 of less than or equal to 70% predicted normal values
  • score of greater than or equal to 2 on the Modified Medical Resarch Council Dyspnea Scale (mMRC)

Who cannot join

  • women who are pregnant or lactating or are planning on becoming pregnant during the study
  • current diagnosis of asthma
  • other respiratory disorders other than COPD
  • other diseases/abnormalities that are uncontrolled including cancer not in remission for at least 5 years
  • chest x-ray or CT scan with clinically significant abnormalities not believed to be due to COPD
  • hypersensitivity to anticholinergics, beta-agonists, lactose/milk protein or magnesium stearate or medical conditions associated with inhaled anticholinergics
Show all 29Show fewer
  • hospitalization for COPD or pneumonia within 12 weeks prior to Visit 1
  • lung volume reduction surgery within 12 months prior to Visit 1
  • abnormal and clinically significant ECG at Visit 1
  • significantly abnormal finding from laboratory tests at Visit 1
  • unable to withhold albuterol/salbutamol at least 4 hours prior to spirometry at each visit
  • use of depot corticosteroids within 12 weeks of Visit 1
  • use of oral or parenteral corticosteroids, antibiotics for lower respiratory tract infection, or cytochrome P450 3A4 inhibitors, within 6 weeks of Visit 1
  • use of long-acting beta-agonist (LABA)/inhaled corticosteroid (ICS) product if LABA/ICS therapy is discontinued withing 30 days of Visit 1
  • use of ICS at a dose of >1000mcg/day of fluticasone propionate or equivalent within 30 days of Visit 1
  • initiation or discontinuation of ICS within 30 days of Visit 1
  • use of tiotropium or roflumilast within 14 days of Visit 1
  • use of theophyllines, oral leukotriene inhibitors, long-acting oral beta-agonists, or inhaled long-acting beta-agonists within 48 hours of Visit 1
  • short-acting oral beta-agonists within 12 hours of Visit 1
  • use of LABA/ICS combination products only if discontinuing LABA therapy and switching to ICS monotherapy within 48 hours of Visit 1 for the LABA component
  • use of sodium cromoglycate or nedocromil sodium within 24 hours of Visit 1
  • use of inhaled short-acting beta-agonists, inhaled short-acting anticholinergics, or inhaled short-acting anticholinergic/short-acting beta-agonist combination products within 4 hours of Visit 1
  • use of any other investigational medication within 30 days or 5 drug half-lives (whichever is longer)
  • long-term oxygen therapy prescribed for >12 hours per day
  • regular use of nebulized short-acting bronchodilators
  • participation in acute phase of pulmonary rehabilitation program
  • known or suspected history of alcohol or drug abse within 2 years prior to Visit 1
  • anyone affiliated with the investigator site (e.g., investigator, sub-investigator, study coordinator, employee of a participating investigator or study site, or immediate family member)
  • previous exposure to GSK573719, GSK573719/GW642444 combination, GW642444 (vilanterol), or fluticasone furoate/GW642444 combination

Trial locations and contacts

100 sites in 10 countries.

100 sites in 10 countries

United States20 sites

  • GSK Investigational Site

    Beaver, Pennsylvania, 15009

  • GSK Investigational Site

    Charlotte, North Carolina, 28207

  • GSK Investigational Site

    Cincinnati, Ohio, 45231

  • GSK Investigational Site

    Clearwater, Florida, 33765

  • GSK Investigational Site

    Easley, South Carolina, 29640

  • GSK Investigational Site

    Elizabeth City, North Carolina, 27909

  • GSK Investigational Site

    Huntington Beach, California, 92647

  • GSK Investigational Site

    Jasper, Alabama, 35501

  • GSK Investigational Site

    Lafayette, Louisiana, 70503

  • GSK Investigational Site

    Lawrenceville, Georgia, 30046

  • GSK Investigational Site

    Los Angeles, California, 90048

  • GSK Investigational Site

    Madisonville, Kentucky, 42431

  • GSK Investigational Site

    Medford, Oregon, 97504

  • GSK Investigational Site

    Mobile, Alabama, 36608

  • GSK Investigational Site

    Morgantown, West Virginia, 26505

  • GSK Investigational Site

    New Orleans, Louisiana, 70115

  • GSK Investigational Site

    Ormond Beach, Florida, 32174

  • GSK Investigational Site

    Spartanburg, South Carolina, 29303

  • GSK Investigational Site

    St Louis, Missouri, 63141

  • GSK Investigational Site

    Topeka, Kansas, 66606

Other trials in United States

Germany17 sites

  • GSK Investigational Site

    Aschaffenburg, Bavaria, 63739

  • GSK Investigational Site

    Berlin, State of Berlin, 10629

  • GSK Investigational Site

    Berlin, State of Berlin, 12099

  • GSK Investigational Site

    Düren, North Rhine-Westphalia, 52349

  • GSK Investigational Site

    Essen, North Rhine-Westphalia, 45355

  • GSK Investigational Site

    Essen, North Rhine-Westphalia, 45359

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60389

  • GSK Investigational Site

    Hamburg, Free and Hanseatic City of Hamburg, 22335

  • GSK Investigational Site

    Kassel, Hesse, 34121

  • GSK Investigational Site

    Koblenz, Rhineland-Palatinate, 56068

  • GSK Investigational Site

    Leipzig, Saxony, 04207

  • GSK Investigational Site

    Mainz, Rhineland-Palatinate, 55116

  • GSK Investigational Site

    Oranienburg, Brandenburg, 16515

  • GSK Investigational Site

    Rüdersdorf, Brandenburg, 15562

  • GSK Investigational Site

    Schwedt, Brandenburg, 16303

  • GSK Investigational Site

    Schwetzingen, Baden-Wurttemberg, 68723

  • GSK Investigational Site

    Wolfenbüttel, Lower Saxony, 38300

Other trials in Germany

South Korea17 sites

  • GSK Investigational Site

    Bucheon-si, 420-767

  • GSK Investigational Site

    Cheongju, Chungcheongbuk-do, 361-711

  • GSK Investigational Site

    Daegu, 705-717

  • GSK Investigational Site

    Incheon, 400-711

  • GSK Investigational Site

    Incheon, 405-760

  • GSK Investigational Site

    Kangwon-do, 220-701

  • GSK Investigational Site

    Seongnam-si, Gyeonggi-do, 463-707

  • GSK Investigational Site

    Seoul, 100-032

  • GSK Investigational Site

    Seoul, 110-744

  • GSK Investigational Site

    Seoul, 130-702

  • GSK Investigational Site

    Seoul, 130-848

  • GSK Investigational Site

    Seoul, 136-705

  • GSK Investigational Site

    Seoul, 143-729

  • GSK Investigational Site

    Seoul, 152-703

  • GSK Investigational Site

    Seoul, 156-707

  • GSK Investigational Site

    Seoul

  • GSK Investigational Site

    Suwon, Kyonggi-do, 443-721

Other trials in South Korea

Canada10 sites

  • GSK Investigational Site

    Bay Roberts, Newfoundland and Labrador, A0A 1G0

  • GSK Investigational Site

    Gatineau, Quebec, J8Y 6S8

  • GSK Investigational Site

    Greater Sudbury, Ontario, P3E 1H5

  • GSK Investigational Site

    Mississauga, Ontario, L5M 2V8

  • GSK Investigational Site

    Québec, Quebec, G1V 4G5

  • GSK Investigational Site

    St-Romulad, Quebec, G6W 5M6

  • GSK Investigational Site

    Toronto, Ontario, M5T 3A9

  • GSK Investigational Site

    Truro, Nova Scotia, B2N 1L2

  • GSK Investigational Site

    Winnipeg, Manitoba, R2H 2A6

  • GSK Investigational Site

    Winnipeg, Manitoba, R2K 3S8

Other trials in Canada

Australia9 sites

  • GSK Investigational Site

    Adelaide, South Australia, 5000

  • GSK Investigational Site

    Cairns, Queensland, 4870

  • GSK Investigational Site

    Carina Heights, Queensland, 4152

  • GSK Investigational Site

    Concord, New South Wales, 2139

  • GSK Investigational Site

    Daw Park, South Australia, 5041

  • GSK Investigational Site

    Frankston, Victoria, 3199

  • GSK Investigational Site

    Kippa-Ring, Queensland, 4021

  • GSK Investigational Site

    Nedlands, Western Australia, 6009

  • GSK Investigational Site

    Parkville, Victoria, 3050

Other trials in Australia

South Africa8 sites

  • GSK Investigational Site

    Bloemfontein, 9301

  • GSK Investigational Site

    Boksburg North, 1459

  • GSK Investigational Site

    Die Wilgers, 0041

  • GSK Investigational Site

    Durban, 4091

  • GSK Investigational Site

    Gatesville, 7764

  • GSK Investigational Site

    Groenkloof, 0181

  • GSK Investigational Site

    Pretoria, 0002

  • GSK Investigational Site

    Thabazimbi, 0380

Other trials in South Africa

Chile7 sites

  • GSK Investigational Site

    Port Montt, Los Lagos Region, 5480000

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 7500551

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 7500710

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 7500800

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 7601003

  • GSK Investigational Site

    Santiago, 8380453

  • GSK Investigational Site

    Talca, Región Metro de Santiago, 3460001

Other trials in Chile

Argentina5 sites

  • GSK Investigational Site

    Buenos Aires, Buenos Aires, C1424BSF

  • GSK Investigational Site

    Buenos Aires, C1425BEN

  • GSK Investigational Site

    Buenos Aires, C1426ABP

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1028AAP

  • GSK Investigational Site

    Mendoza, Mendoza Province, M5500CCG

Other trials in Argentina

Mexico4 sites

  • GSK Investigational Site

    Durango, Durango, 34080

  • GSK Investigational Site

    México, 14000

  • GSK Investigational Site

    Monterrey, Nuevo León, 64020

  • GSK Investigational Site

    Zapopan, Jalisco, 45040

Other trials in Mexico

Romania3 sites

  • GSK Investigational Site

    Constanța, 900002

  • GSK Investigational Site

    Ploieşti, 100379

  • GSK Investigational Site

    Targoviste, 130086

Other trials in Romania

About this study

Official title: A Multi-center Trial Comparing the Efficacy and Safety of GSK573719/GW642444 With GSK573719 and With Tiotropium Over 24 Weeks in Subjects With COPD

This is a Phase III multicenter, randomized, double-blind, double-dummy, parallel-group study to evaluate the efficacy and safety of two doses of GSK573719/GW642444 Inhalation Powder, GSK573719 Inhalation Powder via a Novel Dry Powder Inhaler and tiotropium via HandiHaler when administered once-daily over a 24-week treatment period in subjects with chronic obstructive pulmonary disease (COPD). Subjects who meet eligibility criteria at Screening (Visit 1) will complete a 7 to10 day run-in period followed by a randomization visit (Visit 2) then a 24-week treatment period. There will be a total of 9 clinic study visits. A follow-up phone contact for adverse event assessment will be conducted approximately one week after the last study visit (Visit 9 or Early Withdrawal). The total duration of subject participation in the study will be approximately 26 weeks. The primary measure of efficacy is clinic visit trough (pre-bronchodilator and pre-dose) forced expiratory volume in one second (FEV1) on Treatment Day 169. Safety will be assessed by adverse events, 12-lead ECGs, vital signs, and clinical laboratory tests.

Read the detailed description

This is a 24-week, Phase III multicenter, randomized, double-blind, double-dummy, parallel-group study. Eligible subjects will be randomized to GSK573719/GW642444 125/25mcg, GSK573719/GW642444 62.5/25mcg, GSK573719 125mcg, or tiotropium treatment groups in a 1:1:1:1 ratio. Treatments will be administered once-daily in the morning by inhalation using a Novel Dry Powder Inhaler (Novel DPI) and HandiHaler. There will be a total of 9 study clinic visits conducted on an outpatient basis. Subjects who meet the eligibility criteria at Screening (Visit 1) will complete a 7 to 10 day run-in period followed by a 24-week treatment period. Clinic visits will be at Screening, Randomization (Day 1), Day 2, after 4, 8, 12, 16, and 24-weeks of treatment, and 1 day after the Week 24 Visit (also referred as Treatment Day 169). A follow-up contact for adverse assessment will be conducted by telephone approximately 7 days after Visit 9 or the Early Withdrawal Visit. The total duration of subject participation, including follow-up will be approximately 26 weeks. All subjects will be provided with albuterol/salbutamol for use on an "as-needed" basis throughout the run-in and study treatment periods. At screening, pre-bronchodilator spirometry testing will be followed by post-albuterol/salbutamol spirometry testing. Post-albuterol/salbutamol FEV1 and FEV1/forced vital capacity (FVC) values will be used to determine subject eligibility. To further characterize bronchodilator responsiveness, post-ipratropium testing will be conducted following completion of post-albuterol/salbutamol spirometry. Spirometry will be conducted at each post-randomization clinic visit. Six hour post-dose serial spirometry will be conducted at Visits 2, 6, and 8. Trough spirometry will be obtained 23 and 24 hours after the previous day's dose of blinded study medication at Visits 3 to 9. All subjects will be provided with an electronic diary (eDiary) for completion daily in the morning and the evening throughout the run-in and treatment periods. Subjects will use the eDiary to record peak expiratory flow (PEF) each morning, dyspnea scores using the Shortness of Breath with Daily Activities instrument (SOBDA), daily use of supplemental albuterol/salbutamol as either puffs/day from a metered-dose inhaler (MDI) and/or nebules used per day, and any healthcare contacts related to COPD. Additional assessments of dyspnea will be obtained using the Baseline and Transition Dyspnea Index (BDI/TDI) which is an interviewer based instrument. At Visit 2, the severity of dyspnea at baseline will be assessed using the BDI. At subsequent visits (Visits 4, 6, and 8) change from baseline will be assessed using the TDI. General health status will be evaluated using the subject-completed EQ-5D questionnaire at Visits 2, 4, 6, and 8. Disease specific health status will be evaluated using the subject-completed St. George's Respiratory Questionnaire (SGRQ) at Visits 2, 4, 6, and 8, and the subject-completed COPD Assessment Test (CAT) at Visits 2, 6, and 8. The occurrence of adverse events will be evaluated throughout the study beginning at Visit 2. SAEs will be collected over the same time period as for AEs. However, any SAEs assessed as related to study participation (e.g., study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy) or related to a GSK concomitant medication, will be recorded from the time a subject consents to participate in the study up to and including any follow up contact. Additional safety assessments of vital signs (blood pressure and pulse rate), 12-lead ECGs and standard clinical laboratory tests (hematology and chemistry) will be obtained at selected clinic visits.

Being tested
GSK573719/GW642444 125/25, GSK573719/GW642444 62.5/25, GSK573719, tiotropium bromide
Keywords
tiotropium, long-acting muscarinic antagonist, COPD, long-acting beta agonist
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.

  • GSK573719/GW642444 125/25Drug

    Also called GSK573719/vilanterol trifenatate

    125/25 mcg once-daily

  • GSK573719/GW642444 62.5/25Drug

    Also called GSK573719/vilanterol trifenatate

    62.5/25 mcg once-daily

  • GSK573719Drug

    125 mcg once-daily

  • tiotropium bromideDrug

    18 mcg once-daily

Study groups in NCT01316913
Study groupRoleWhat they receive
GSK573719/GW642444 125/25Experimental125/25 mcg once-daily
Receives: Drug: GSK573719/GW642444 125/25
GSK573719/GW642444 62.5/25Experimental62.5/25 mcg once-daily
Receives: Drug: GSK573719/GW642444 62.5/25
GSK573719Experimental125 mcg once-daily
Receives: Drug: GSK573719
tiotropium bromideActive comparator18 mcg once-daily
Receives: Drug: tiotropium bromide

What is being measured

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

  1. Change From Baseline in Clinic Visit Trough Forced Expiratory Volume in One Second (FEV1) at Day 169

    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 measurements were taken electronically by spirometry on Days 2, 28, 56, 84, 112, 168, and 169. Baseline is defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after the previous morning's dosing (i.e., trough FEV1 on Day 169 is the mean of the FEV1 values obtained 23 and 24 hours after the morning dosing on Day 168). Change from Baseline at a particular visit was calculated as the trough FEV1 at that visit minus Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline, smoking status, center group, day, and day by Baseline and day by treatment interactions. ITT=Intent-to-Treat.

    Measured: Baseline and Day 169

Secondary outcomes (1)

  1. Change From Baseline (BL) in Weighted Mean (WM) 0-6 Hour FEV1 Obtained Post-dose at Day 168

    FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The WM was calculated at Days 1, 84, and Day 168 using the 0-6-hour post-dose FEV1 measurements collected on that day, which included pre-dose (Day 1: 30 minutes [min] and 5 min prior to dosing; other serial visits: 23 and 24 hours after the previous morning dose) and post-dose at 15 minutes, 30 minutes, 1 hour, 3 hours, and 6 hours. Change from BL at a particular visit was calculated as WM at that visit minus BL. Analysis was performed using a repeated measures model with covariates of treatment, BL (mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1), smoking status, center group, day, and day by BL and day by treatment interactions.

    Measured: Baseline and Day 168

Timeline

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

  1. First posted16 Mar 2011 (estimated)
  2. Study startMar 2011
  3. Primary completionApr 2012
  4. Study completionApr 2012

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
872 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01316913
Sponsor's protocol ID
113374
Status last verified
Mar 2017
First submitted
15 Mar 2011
Last updated
4 Apr 2017
Data monitoring committee
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

  • Maleki-Yazdi MR, Singh D, Anzueto A, Tombs L, Fahy WA, Naya I. Assessing Short-term Deterioration in Maintenance-naive Patients with COPD Receiving Umeclidinium/Vilanterol and Tiotropium: A Pooled Analysis of Three Randomized Trials. Adv Ther. 2017 Jan;33(12):2188-2199. doi: 10.1007/s12325-016-0430-6. Epub 2016 Oct 28.

    PubMed 27796912

  • Decramer M, Anzueto A, Kerwin E, Kaelin T, Richard N, Crater G, Tabberer M, Harris S, Church A. Efficacy and safety of umeclidinium plus vilanterol versus tiotropium, vilanterol, or umeclidinium monotherapies over 24 weeks in patients with chronic obstructive pulmonary disease: results from two multicentre, blinded, randomised controlled trials. Lancet Respir Med. 2014 Jun;2(6):472-86. doi: 10.1016/S2213-2600(14)70065-7. Epub 2014 May 14.

    PubMed 24835833

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GSK573719/GW642444 125/25, GSK573719/GW642444 62.5/25 and GSK573719 in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 100 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 29 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 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 100 sites in United States, Germany, South Korea, Canada, Australia 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 24 Feb 2014). 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 Clinic Visit Trough Forced Expiratory Volume in One Second (FEV1) at Day 169 (time frame: Baseline and Day 169). 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 NCT01316913, 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 4 Apr 2017.

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