24-week Trial Comparing GSK573719/GW642444 With GW642444 and With Tiotropium in Chronic Obstructive Pulmonary Disease
A Multicenter Trial Comparing the Efficacy and Safety of GSK573719/GW642444 With GW642444 and With Tiotropium Over 24 Weeks in Subjects With COPD
1 other identifier
interventional
846
10 countries
97
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 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.
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
97 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 24, 2012
CompletedResults Posted
Study results publicly available
February 10, 2014
CompletedJanuary 24, 2018
January 1, 2018
1.1 years
March 15, 2011
December 19, 2013
January 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (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. .
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
GW642444
EXPERIMENTAL25 mcg once-daily
tiotropium bromide
ACTIVE COMPARATOR18 mcg once-daily
Interventions
125/25 mcg once-daily
62.5/26 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 (97)
GSK Investigational Site
Birmingham, Alabama, 35216, United States
GSK Investigational Site
San Diego, California, 92117, United States
GSK Investigational Site
DeLand, Florida, 32720, United States
GSK Investigational Site
Orlando, Florida, 32822, United States
GSK Investigational Site
Tampa, Florida, 33603, United States
GSK Investigational Site
Decatur, Georgia, 30033, United States
GSK Investigational Site
Saint Charles, Missouri, 63301, United States
GSK Investigational Site
Albuquerque, New Mexico, 87108, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73103, United States
GSK Investigational Site
Phoenixville, Pennsylvania, 19460, United States
GSK Investigational Site
Charleston, South Carolina, 29406-7108, United States
GSK Investigational Site
Gaffney, South Carolina, 29340, United States
GSK Investigational Site
Greenville, South Carolina, 29615, United States
GSK Investigational Site
Rock Hill, South Carolina, 29732, United States
GSK Investigational Site
Seneca, South Carolina, 29678, United States
GSK Investigational Site
Rapid City, South Dakota, 57702, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
Newport News, Virginia, 23606, United States
GSK Investigational Site
Richmond, Virginia, 23229, United States
GSK Investigational Site
Clermont-Ferrand, 63003, France
GSK Investigational Site
Nantes, 44093, France
GSK Investigational Site
Nîmes, 30029, France
GSK Investigational Site
Saint-Pierre, 97448, France
GSK Investigational Site
Sinsheim, Baden-Wurttemberg, 74889, Germany
GSK Investigational Site
Stuttgart, Baden-Wurttemberg, 70378, Germany
GSK Investigational Site
Bamberg, Bavaria, 96049, Germany
GSK Investigational Site
Erlangen, Bavaria, 91052, Germany
GSK Investigational Site
Munich, Bavaria, 80339, Germany
GSK Investigational Site
Nuremberg, Bavaria, 90402, Germany
GSK Investigational Site
Potsdam, Brandenburg, 14467, Germany
GSK Investigational Site
Marburg, Hesse, 35037, Germany
GSK Investigational Site
Hanover, Lower Saxony, 30159, Germany
GSK Investigational Site
Hanover, Lower Saxony, 30173, Germany
GSK Investigational Site
Dortmund, North Rhine-Westphalia, 44147, Germany
GSK Investigational Site
Dortmund, North Rhine-Westphalia, 44263, Germany
GSK Investigational Site
Berlin, 10717, Germany
GSK Investigational Site
Berlin, 12157, Germany
GSK Investigational Site
Berlin, 12203, Germany
GSK Investigational Site
Berlin, 13086, Germany
GSK Investigational Site
Hamburg, 22299, Germany
GSK Investigational Site
Foggia, Apulia, 71100, Italy
GSK Investigational Site
Avellino, Campania, 83100, Italy
GSK Investigational Site
Pordenone, Friuli Venezia Giulia, 33170, Italy
GSK Investigational Site
Rome, Lazio, 00144, Italy
GSK Investigational Site
Pietra Ligure (SV), Liguria, 17027, Italy
GSK Investigational Site
Milan, Lombardy, 20121, Italy
GSK Investigational Site
Pavia, Lombardy, 27100, Italy
GSK Investigational Site
Tradate (VA), Lombardy, 21049, Italy
GSK Investigational Site
Catania, Sicily, 95123, Italy
GSK Investigational Site
Pisa, Tuscany, 56124, Italy
GSK Investigational Site
Guadalajara, Jalisco, 44100, Mexico
GSK Investigational Site
Zapopan, Jalisco, 45200, Mexico
GSK Investigational Site
Mexico City, 07760, Mexico
GSK Investigational Site
México, 10700, Mexico
GSK Investigational Site
Lima, Lima Province, Lima 27, Peru
GSK Investigational Site
Jesus Maria, Lima region, Lima 11, Peru
GSK Investigational Site
San Borja, Lima region, Lima 41, Peru
GSK Investigational Site
San Isidro, Lima region, Lima 27, Peru
GSK Investigational Site
San Miguel, Lima region, Lima 32, Peru
GSK Investigational Site
Santiago de Surco, Lima region, Lima 33, Peru
GSK Investigational Site
Callao, Callao 2, Peru
GSK Investigational Site
Lima, Lima 1, Peru
GSK Investigational Site
Gdansk, 80-405, Poland
GSK Investigational Site
Gidle, 97-540, Poland
GSK Investigational Site
Krakow, 31-023, Poland
GSK Investigational Site
Lubliniec, 42-700, Poland
GSK Investigational Site
Sopot, 81-741, Poland
GSK Investigational Site
Włocławek, 87-800, Poland
GSK Investigational Site
Zabrze, 41-800, Poland
GSK Investigational Site
Bacau, 600252, Romania
GSK Investigational Site
Bucharest, 011794, Romania
GSK Investigational Site
Ploieşti, 100184, Romania
GSK Investigational Site
Timișoara, 300310, Romania
GSK Investigational Site
Chita, 672000, Russia
GSK Investigational Site
Irkutsk, 664005, Russia
GSK Investigational Site
Moscow, 115446, Russia
GSK Investigational Site
Petrozavodsk, 185019, Russia
GSK Investigational Site
Ryazan, 390039, Russia
GSK Investigational Site
Saint Petersburg, 194354, Russia
GSK Investigational Site
Saratov, 410018, Russia
GSK Investigational Site
Saratov, 410028, Russia
GSK Investigational Site
Tomsk, 634001, Russia
GSK Investigational Site
Voronezh, 394018, Russia
GSK Investigational Site
Yaroslavl, Russia
GSK Investigational Site
Dnipropetrovsk, 49027, Ukraine
GSK Investigational Site
Dnipropetrovsk, 49074, Ukraine
GSK Investigational Site
Donetsk, 83099, Ukraine
GSK Investigational Site
Ivano-Frankivsk, 76018, Ukraine
GSK Investigational Site
Kharkiv, 61037, Ukraine
GSK Investigational Site
Kharkiv, 61124, Ukraine
GSK Investigational Site
Kiev, 03680, Ukraine
GSK Investigational Site
Kyiv, 01114, Ukraine
GSK Investigational Site
Kyiv, 03038, Ukraine
GSK Investigational Site
Kyiv, 03680, Ukraine
GSK Investigational Site
Simferopol, 95043, Ukraine
GSK Investigational Site
Vinnytsia, 21029, Ukraine
GSK Investigational Site
Zaporizhia, 69035, Ukraine
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 24, 2012
Last Updated
January 24, 2018
Results First Posted
February 10, 2014
Record last verified: 2018-01
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.