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Pulmonary Disease, Chronic ObstructivePhase 3NCT01316900

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

A Phase 3 study testing GSK573719/GW642444 125/25, GSK573719/GW642444 62.5/25 and GW642444 in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 97 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 and GW642444 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 GW642444
Could I receive a placebo?
No, everyone receives an active treatment
How many people
846 participants
Where
97 sitesin 10 countries
Study dates
1 Mar 2011to 24 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

97 sites in 10 countries.

97 sites in 10 countries

United States19 sites

  • GSK Investigational Site

    Albuquerque, New Mexico, 87108

  • GSK Investigational Site

    Birmingham, Alabama, 35216

  • GSK Investigational Site

    Charleston, South Carolina, 29406-7108

  • GSK Investigational Site

    Decatur, Georgia, 30033

  • GSK Investigational Site

    DeLand, Florida, 32720

  • GSK Investigational Site

    Gaffney, South Carolina, 29340

  • GSK Investigational Site

    Greenville, South Carolina, 29615

  • GSK Investigational Site

    Newport News, Virginia, 23606

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73103

  • GSK Investigational Site

    Orlando, Florida, 32822

  • GSK Investigational Site

    Phoenixville, Pennsylvania, 19460

  • GSK Investigational Site

    Rapid City, South Dakota, 57702

  • GSK Investigational Site

    Richmond, Virginia, 23229

  • GSK Investigational Site

    Rock Hill, South Carolina, 29732

  • GSK Investigational Site

    Saint Charles, Missouri, 63301

  • GSK Investigational Site

    San Antonio, Texas, 78229

  • GSK Investigational Site

    San Diego, California, 92117

  • GSK Investigational Site

    Seneca, South Carolina, 29678

  • GSK Investigational Site

    Tampa, Florida, 33603

Other trials in United States

Germany17 sites

  • GSK Investigational Site

    Bamberg, Bavaria, 96049

  • GSK Investigational Site

    Berlin, 10717

  • GSK Investigational Site

    Berlin, 12157

  • GSK Investigational Site

    Berlin, 12203

  • GSK Investigational Site

    Berlin, 13086

  • GSK Investigational Site

    Dortmund, North Rhine-Westphalia, 44147

  • GSK Investigational Site

    Dortmund, North Rhine-Westphalia, 44263

  • GSK Investigational Site

    Erlangen, Bavaria, 91052

  • GSK Investigational Site

    Hamburg, 22299

  • GSK Investigational Site

    Hanover, Lower Saxony, 30159

  • GSK Investigational Site

    Hanover, Lower Saxony, 30173

  • GSK Investigational Site

    Marburg, Hesse, 35037

  • GSK Investigational Site

    Munich, Bavaria, 80339

  • GSK Investigational Site

    Nuremberg, Bavaria, 90402

  • GSK Investigational Site

    Potsdam, Brandenburg, 14467

  • GSK Investigational Site

    Sinsheim, Baden-Wurttemberg, 74889

  • GSK Investigational Site

    Stuttgart, Baden-Wurttemberg, 70378

Other trials in Germany

Ukraine13 sites

  • GSK Investigational Site

    Dnipropetrovsk, 49027

  • GSK Investigational Site

    Dnipropetrovsk, 49074

  • GSK Investigational Site

    Donetsk, 83099

  • GSK Investigational Site

    Ivano-Frankivsk, 76018

  • GSK Investigational Site

    Kharkiv, 61037

  • GSK Investigational Site

    Kharkiv, 61124

  • GSK Investigational Site

    Kiev, 03680

  • GSK Investigational Site

    Kyiv, 01114

  • GSK Investigational Site

    Kyiv, 03038

  • GSK Investigational Site

    Kyiv, 03680

  • GSK Investigational Site

    Simferopol, 95043

  • GSK Investigational Site

    Vinnytsia, 21029

  • GSK Investigational Site

    Zaporizhia, 69035

Other trials in Ukraine

Russia11 sites

  • GSK Investigational Site

    Chita, 672000

  • GSK Investigational Site

    Irkutsk, 664005

  • GSK Investigational Site

    Moscow, 115446

  • GSK Investigational Site

    Petrozavodsk, 185019

  • GSK Investigational Site

    Ryazan, 390039

  • GSK Investigational Site

    Saint Petersburg, 194354

  • GSK Investigational Site

    Saratov, 410018

  • GSK Investigational Site

    Saratov, 410028

  • GSK Investigational Site

    Tomsk, 634001

  • GSK Investigational Site

    Voronezh, 394018

  • GSK Investigational Site

    Yaroslavl

Other trials in Russia

Italy10 sites

  • GSK Investigational Site

    Avellino, Campania, 83100

  • GSK Investigational Site

    Catania, Sicily, 95123

  • GSK Investigational Site

    Foggia, Apulia, 71100

  • GSK Investigational Site

    Milan, Lombardy, 20121

  • GSK Investigational Site

    Pavia, Lombardy, 27100

  • GSK Investigational Site

    Pietra Ligure (SV), Liguria, 17027

  • GSK Investigational Site

    Pisa, Tuscany, 56124

  • GSK Investigational Site

    Pordenone, Friuli Venezia Giulia, 33170

  • GSK Investigational Site

    Rome, Lazio, 00144

  • GSK Investigational Site

    Tradate (VA), Lombardy, 21049

Other trials in Italy

Peru8 sites

  • GSK Investigational Site

    Callao, Callao 2

  • GSK Investigational Site

    Jesus Maria, Lima region, Lima 11

  • GSK Investigational Site

    Lima, Lima Province, Lima 27

  • GSK Investigational Site

    Lima, Lima 1

  • GSK Investigational Site

    San Borja, Lima region, Lima 41

  • GSK Investigational Site

    San Isidro, Lima region, Lima 27

  • GSK Investigational Site

    San Miguel, Lima region, Lima 32

  • GSK Investigational Site

    Santiago de Surco, Lima region, Lima 33

Other trials in Peru

Poland7 sites

  • GSK Investigational Site

    Gdansk, 80-405

  • GSK Investigational Site

    Gidle, 97-540

  • GSK Investigational Site

    Krakow, 31-023

  • GSK Investigational Site

    Lubliniec, 42-700

  • GSK Investigational Site

    Sopot, 81-741

  • GSK Investigational Site

    Włocławek, 87-800

  • GSK Investigational Site

    Zabrze, 41-800

Other trials in Poland

France4 sites

  • GSK Investigational Site

    Clermont-Ferrand, 63003

  • GSK Investigational Site

    Nantes, 44093

  • GSK Investigational Site

    Nîmes, 30029

  • GSK Investigational Site

    Saint-Pierre, 97448

Other trials in France

Mexico4 sites

  • GSK Investigational Site

    Guadalajara, Jalisco, 44100

  • GSK Investigational Site

    México, 10700

  • GSK Investigational Site

    Mexico City, 07760

  • GSK Investigational Site

    Zapopan, Jalisco, 45200

Other trials in Mexico

Romania4 sites

  • GSK Investigational Site

    Bacau, 600252

  • GSK Investigational Site

    Bucharest, 011794

  • GSK Investigational Site

    Ploieşti, 100184

  • GSK Investigational Site

    Timișoara, 300310

Other trials in Romania

About this study

Official title: A Multicenter Trial Comparing the Efficacy and Safety of GSK573719/GW642444 With GW642444 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 and GW642444 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, GW642444 25mcg, 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, GW642444, tiotropium bromide
Keywords
long-acting muscarinic antagonist, tiotropium, 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

    62.5/26 mcg once-daily

  • GW642444Drug

    Also called vilanterol trifenatate

    25 mcg once-daily

  • tiotropium bromideDrug

    18 mcg once-daily

Study groups in NCT01316900
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
GW642444Experimental25 mcg once-daily
Receives: Drug: GW642444
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 (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (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 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 (ie., 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; par.=participants. .

    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 start1 Mar 2011
  3. Primary completion1 Apr 2012
  4. Study completion24 Apr 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
846 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01316900
Sponsor's protocol ID
113360
Status last verified
Jan 2018
First submitted
15 Mar 2011
Last updated
24 Jan 2018
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 GW642444 in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 97 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 24 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 97 sites in United States, Germany, Ukraine, Russia, Italy 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 10 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 (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24) (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 NCT01316900, 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 24 Jan 2018.

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