A 52-Week, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Safety and Tolerability of GSK573719/GW642444 and GSK573719 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
COPD nDPI
A 52 Week Study to Evaluate the Safety and Tolerability of GSK573719/GW642444 125mcg Once-daily Alone and in Combination With GW642444 25mcg Once-daily Via Novel Dry Powder Inhaler (nDPI) in Subjects With Chronic Obstructive Pulmonary Disease
1 other identifier
interventional
563
6 countries
54
Brief Summary
The purpose of this 52-week study is to evaluate the long-term safety (in terms of adverse events, COPD exacerbations, laboratory, ECG, and Holter findings, vital signs, use of rescue medication and lung function) of GSK573719/GW642444 Inhalation Powder 125/25mcg in subjects with COPD. The long-term safety of GSK573719 Inhalation Powder 125mcg will also be evaluated. A placebo arm is included to evaluate these products compared to an inactive control.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2011
54 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
January 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
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 21, 2012
CompletedResults Posted
Study results publicly available
March 20, 2014
CompletedMay 2, 2018
April 1, 2018
1.5 years
March 15, 2011
December 19, 2013
April 30, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Any On-treatment Adverse Event (AE) or Any Serious Adverse Event (SAE)
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury with hyperbilirubinaemia. Medical or scientific judgment was to have been exercised in other important medical events. AEs with an onset on or after the date of the first dose of study drug and up to 1 day after the date of the last recorded dose of study drug were considered to be on-treatment AEs, Refer to the general AE/SAE module for a complete list of AEs and SAEs.
From the start of study drug up to 52 weeks
Secondary Outcomes (18)
Number of Participants With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Over the Course of the 52-week Treatment Period
From the start of study drug up to 52 weeks
Time to the First On-treatment COPD Exacerbation
From the start of study drug up to 52 weeks
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) at Months 3, 6, 9, and 12
Baseline; Months 3, 6, 9, and 12
Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12
Baseline; Months 3, 6, 9, and 12
Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate, Chloride, Glucose, Inorganic Phosphorus (IP), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Months 3, 6, 9, and 12
Baseline; Months 3, 6, 9, and 12
- +13 more secondary outcomes
Study Arms (3)
GSK573719/GW642444
EXPERIMENTAL125/25 mcg once-daily
GSK573719
EXPERIMENTAL125 mcg once-daily
Placebo
PLACEBO COMPARATORinactive
Interventions
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 greater than or equal to 35% and less than or equal to 80% of predicted normal
You may not qualify if:
- Pregant or lactating women or women planning to become 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
- abnormal and clinically significant Holter monitor finding at Visit 1
- significantly abnormal finding from laboratory tests at Visit 1
- unable to withhold albuterol/salbutamol and/or ipratropium bromide 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 within 6 weeks of Visit 1
- use of anitbiotics for lower respiratory tract infection within 6 weeks of Visit 1
- +24 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (54)
GSK Investigational Site
Mobile, Alabama, 36608, United States
GSK Investigational Site
Sunset, Louisiana, 70584, United States
GSK Investigational Site
Plymouth, Minnesota, 55441, United States
GSK Investigational Site
St Louis, Missouri, 63141, United States
GSK Investigational Site
Charlotte, North Carolina, 28207, United States
GSK Investigational Site
Columbus, Ohio, 43215, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73103, United States
GSK Investigational Site
Erie, Pennsylvania, 16508, United States
GSK Investigational Site
Charleston, South Carolina, 29406-7108, United States
GSK Investigational Site
Spartanburg, South Carolina, 29303, United States
GSK Investigational Site
Union, South Carolina, 29379, United States
GSK Investigational Site
Corsicana, Texas, 75110, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
Richmond, Virginia, 23229, United States
GSK Investigational Site
Morgantown, West Virginia, 26505, United States
GSK Investigational Site
Puente Alto - Santiago, Región Metro de Santiago, 8207257, Chile
GSK Investigational Site
Talca, Región Metro de Santiago, 3460001, Chile
GSK Investigational Site
Santiago, 8380453, Chile
GSK Investigational Site
Bacau, 600252, Romania
GSK Investigational Site
Brasov, 500112, Romania
GSK Investigational Site
Brasov, 500283, Romania
GSK Investigational Site
Bucharest, 70000, Romania
GSK Investigational Site
Piteşti, 110084, Romania
GSK Investigational Site
Ploieşti, 100172, Romania
GSK Investigational Site
Ploieşti, 100379, Romania
GSK Investigational Site
Timișoara, 300310, Romania
GSK Investigational Site
Ivanovo, 153005, Russia
GSK Investigational Site
Moscow, 119 048, Russia
GSK Investigational Site
Moscow, 127018, Russia
GSK Investigational Site
Penza, 440067, Russia
GSK Investigational Site
Saint Petersburg, 193231, Russia
GSK Investigational Site
Saint Petersburg, 194354, Russia
GSK Investigational Site
Shakhty, Rostov Region, 346510, Russia
GSK Investigational Site
Sochi, 354057, Russia
GSK Investigational Site
St'Petersburg, 197706, Russia
GSK Investigational Site
Tomsk, 634 050, Russia
GSK Investigational Site
Tyumen, 625023, Russia
GSK Investigational Site
Veliky Novgorod, 173008, Russia
GSK Investigational Site
Vladivostok, 690950, Russia
GSK Investigational Site
Yekaterinburg, 620109, Russia
GSK Investigational Site
Bratislava, 826 06, Slovakia
GSK Investigational Site
Bratislava, 841 08, Slovakia
GSK Investigational Site
Poprad, 058 01, Slovakia
GSK Investigational Site
Považská Bystrica, 017 26, Slovakia
GSK Investigational Site
Šaľa, 927 01, Slovakia
GSK Investigational Site
Žilina, 012 07, Slovakia
GSK Investigational Site
Benoni, Gauteng, 1501, South Africa
GSK Investigational Site
Bellville, 7530, South Africa
GSK Investigational Site
Bloemfontein, 9301, South Africa
GSK Investigational Site
Durban, 4001, South Africa
GSK Investigational Site
Gatesville, 7764, South Africa
GSK Investigational Site
Mowbray, 7700, South Africa
GSK Investigational Site
Somerset West, 7130, South Africa
GSK Investigational Site
Tygerberg, 7505, South Africa
Related Links
MeSH Terms
Conditions
Condition 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
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2011
First Posted
March 16, 2011
Study Start
January 1, 2011
Primary Completion
July 1, 2012
Study Completion
July 21, 2012
Last Updated
May 2, 2018
Results First Posted
March 20, 2014
Record last verified: 2018-04
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.