24-week Trial Comparing GSK573719/GW642444 With GSK573719 and With Tiotropium in Chronic Obstructive Pulmonary Disease
A Multi-center Trial Comparing the Efficacy and Safety of GSK573719/GW642444 With GSK573719 and With Tiotropium Over 24 Weeks in Subjects With COPD
1 other identifier
interventional
872
10 countries
100
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2011
Shorter than P25 for phase_3
100 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 15, 2011
CompletedFirst Posted
Study publicly available on registry
March 16, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedResults Posted
Study results publicly available
February 24, 2014
CompletedApril 4, 2017
March 1, 2017
1.1 years
March 15, 2011
January 9, 2014
March 7, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Baseline and Day 169
Secondary Outcomes (1)
Change From Baseline (BL) in Weighted Mean (WM) 0-6 Hour FEV1 Obtained Post-dose at Day 168
Baseline and Day 168
Other Outcomes (1)
Change From Baseline (BL) in the Mean Shortness of Breath With Daily Activities (SOBDA) Score for Week 24
Baseline and Week 24
Study Arms (4)
GSK573719/GW642444 125/25
EXPERIMENTAL125/25 mcg once-daily
GSK573719/GW642444 62.5/25
EXPERIMENTAL62.5/25 mcg once-daily
GSK573719
EXPERIMENTAL125 mcg once-daily
tiotropium bromide
ACTIVE COMPARATOR18 mcg once-daily
Interventions
125/25 mcg once-daily
62.5/25 mcg once-daily
Eligibility Criteria
You may qualify if:
- outpatient
- signed and dated written informed consent
- 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)
You may not qualify if:
- 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
- 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
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (100)
GSK Investigational Site
Jasper, Alabama, 35501, United States
GSK Investigational Site
Mobile, Alabama, 36608, United States
GSK Investigational Site
Huntington Beach, California, 92647, United States
GSK Investigational Site
Los Angeles, California, 90048, United States
GSK Investigational Site
Clearwater, Florida, 33765, United States
GSK Investigational Site
Ormond Beach, Florida, 32174, United States
GSK Investigational Site
Lawrenceville, Georgia, 30046, United States
GSK Investigational Site
Topeka, Kansas, 66606, United States
GSK Investigational Site
Madisonville, Kentucky, 42431, United States
GSK Investigational Site
Lafayette, Louisiana, 70503, United States
GSK Investigational Site
New Orleans, Louisiana, 70115, United States
GSK Investigational Site
St Louis, Missouri, 63141, United States
GSK Investigational Site
Charlotte, North Carolina, 28207, United States
GSK Investigational Site
Elizabeth City, North Carolina, 27909, United States
GSK Investigational Site
Cincinnati, Ohio, 45231, United States
GSK Investigational Site
Medford, Oregon, 97504, United States
GSK Investigational Site
Beaver, Pennsylvania, 15009, United States
GSK Investigational Site
Easley, South Carolina, 29640, United States
GSK Investigational Site
Spartanburg, South Carolina, 29303, United States
GSK Investigational Site
Morgantown, West Virginia, 26505, United States
GSK Investigational Site
Buenos Aires, Buenos Aires, C1424BSF, Argentina
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1028AAP, Argentina
GSK Investigational Site
Mendoza, Mendoza Province, M5500CCG, Argentina
GSK Investigational Site
Buenos Aires, C1425BEN, Argentina
GSK Investigational Site
Buenos Aires, C1426ABP, Argentina
GSK Investigational Site
Concord, New South Wales, 2139, Australia
GSK Investigational Site
Cairns, Queensland, 4870, Australia
GSK Investigational Site
Carina Heights, Queensland, 4152, Australia
GSK Investigational Site
Kippa-Ring, Queensland, 4021, Australia
GSK Investigational Site
Adelaide, South Australia, 5000, Australia
GSK Investigational Site
Daw Park, South Australia, 5041, Australia
GSK Investigational Site
Frankston, Victoria, 3199, Australia
GSK Investigational Site
Parkville, Victoria, 3050, Australia
GSK Investigational Site
Nedlands, Western Australia, 6009, Australia
GSK Investigational Site
Winnipeg, Manitoba, R2H 2A6, Canada
GSK Investigational Site
Winnipeg, Manitoba, R2K 3S8, Canada
GSK Investigational Site
Bay Roberts, Newfoundland and Labrador, A0A 1G0, Canada
GSK Investigational Site
Truro, Nova Scotia, B2N 1L2, Canada
GSK Investigational Site
Greater Sudbury, Ontario, P3E 1H5, Canada
GSK Investigational Site
Mississauga, Ontario, L5M 2V8, Canada
GSK Investigational Site
Toronto, Ontario, M5T 3A9, Canada
GSK Investigational Site
Gatineau, Quebec, J8Y 6S8, Canada
GSK Investigational Site
Québec, Quebec, G1V 4G5, Canada
GSK Investigational Site
St-Romulad, Quebec, G6W 5M6, Canada
GSK Investigational Site
Port Montt, Los Lagos Region, 5480000, Chile
GSK Investigational Site
Santiago, Región Metro de Santiago, 7500551, Chile
GSK Investigational Site
Santiago, Región Metro de Santiago, 7500710, Chile
GSK Investigational Site
Santiago, Región Metro de Santiago, 7500800, Chile
GSK Investigational Site
Santiago, Región Metro de Santiago, 7601003, Chile
GSK Investigational Site
Talca, Región Metro de Santiago, 3460001, Chile
GSK Investigational Site
Santiago, 8380453, Chile
GSK Investigational Site
Schwetzingen, Baden-Wurttemberg, 68723, Germany
GSK Investigational Site
Aschaffenburg, Bavaria, 63739, Germany
GSK Investigational Site
Oranienburg, Brandenburg, 16515, Germany
GSK Investigational Site
Rüdersdorf, Brandenburg, 15562, Germany
GSK Investigational Site
Schwedt, Brandenburg, 16303, Germany
GSK Investigational Site
Hamburg, Hamburg, 22335, Germany
GSK Investigational Site
Frankfurt am Main, Hesse, 60389, Germany
GSK Investigational Site
Kassel, Hesse, 34121, Germany
GSK Investigational Site
Wolfenbüttel, Lower Saxony, 38300, Germany
GSK Investigational Site
Düren, North Rhine-Westphalia, 52349, Germany
GSK Investigational Site
Essen, North Rhine-Westphalia, 45355, Germany
GSK Investigational Site
Essen, North Rhine-Westphalia, 45359, Germany
GSK Investigational Site
Koblenz, Rhineland-Palatinate, 56068, Germany
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55116, Germany
GSK Investigational Site
Leipzig, Saxony, 04207, Germany
GSK Investigational Site
Berlin, State of Berlin, 10629, Germany
GSK Investigational Site
Berlin, State of Berlin, 12099, Germany
GSK Investigational Site
Durango, Durango, 34080, Mexico
GSK Investigational Site
Zapopan, Jalisco, 45040, Mexico
GSK Investigational Site
Monterrey, Nuevo León, 64020, Mexico
GSK Investigational Site
México, 14000, Mexico
GSK Investigational Site
Constanța, 900002, Romania
GSK Investigational Site
Ploieşti, 100379, Romania
GSK Investigational Site
Târgovişte, 130086, Romania
GSK Investigational Site
Bloemfontein, 9301, South Africa
GSK Investigational Site
Boksburg North, 1459, South Africa
GSK Investigational Site
Die Wilgers, 0041, South Africa
GSK Investigational Site
Durban, 4091, South Africa
GSK Investigational Site
Gatesville, 7764, South Africa
GSK Investigational Site
Groenkloof, 0181, South Africa
GSK Investigational Site
Pretoria, 0002, South Africa
GSK Investigational Site
Thabazimbi, 0380, South Africa
GSK Investigational Site
Bucheon-si, 420-767, South Korea
GSK Investigational Site
Cheongju, Chungcheongbuk-do, 361-711, South Korea
GSK Investigational Site
Daegu, 705-717, South Korea
GSK Investigational Site
Incheon, 400-711, South Korea
GSK Investigational Site
Incheon, 405-760, South Korea
GSK Investigational Site
Kangwon-do, 220-701, South Korea
GSK Investigational Site
Seongnam-si, Gyeonggi-do, 463-707, South Korea
GSK Investigational Site
Seoul, 100-032, South Korea
GSK Investigational Site
Seoul, 110-744, South Korea
GSK Investigational Site
Seoul, 130-702, South Korea
GSK Investigational Site
Seoul, 130-848, South Korea
GSK Investigational Site
Seoul, 136-705, South Korea
GSK Investigational Site
Seoul, 143-729, South Korea
GSK Investigational Site
Seoul, 152-703, South Korea
GSK Investigational Site
Seoul, 156-707, South Korea
GSK Investigational Site
Seoul, South Korea
GSK Investigational Site
Suwon, Kyonggi-do, 443-721, South Korea
Related Publications (2)
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.
PMID: 27796912DERIVEDDecramer 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.
PMID: 24835833DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2011
First Posted
March 16, 2011
Study Start
March 1, 2011
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
April 4, 2017
Results First Posted
February 24, 2014
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.