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)

Completed · Phase 3 · Has a placebo group

Conditions studied: Pulmonary Disease, Chronic Obstructive

In brief

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.

Key facts

Study ID

NCT01316887

Run by

GlaxoSmithKline

People needed

563

Starts

2011-01-01

Expected to finish

2012-07-21

Last updated by the study team

2018-05-02

Who can join

Age: 40 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 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
• use of cytochrome P450 3A4 inhibitors within 6 weeks of Visit 1
• us of long-acting beta-agonist (LABA)/inhaled corticosteroid (ICS) products if LABA/ICS therapy is discontinued completely within 30 days of Visit 1
• use of ICS at a dose of >10000mcg/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 within 14 days of Visit 1
• use of roflumilast within 14 days of Visit 1
• use of theophyllines within 48 hours of Visit 1
• use of oral leukotriene inhibitors within 48 hours prior to Visit 1
• use of long-acting oral beta-agonists within 48 hours of Visit 1
• use of short-acting oral beta-agonists within 12 hours of Visit 1

Where it is running

• GSK Investigational Site — Sunset, Louisiana, United States
• GSK Investigational Site — Plymouth, Minnesota, United States
• GSK Investigational Site — St Louis, Missouri, United States
• GSK Investigational Site — Charlotte, North Carolina, United States
• GSK Investigational Site — Columbus, Ohio, United States
• GSK Investigational Site — Oklahoma City, Oklahoma, United States
• GSK Investigational Site — Erie, Pennsylvania, United States
• GSK Investigational Site — Charleston, South Carolina, United States
• GSK Investigational Site — Spartanburg, South Carolina, United States
• GSK Investigational Site — Union, South Carolina, United States
• GSK Investigational Site — Corsicana, Texas, United States
• GSK Investigational Site — San Antonio, Texas, United States
• GSK Investigational Site — Richmond, Virginia, United States
• GSK Investigational Site — Morgantown, West Virginia, United States
• GSK Investigational Site — Puente Alto - Santiago, Región Metro de Santiago, Chile
• GSK Investigational Site — Talca, Región Metro de Santiago, Chile
• GSK Investigational Site — Santiago, Chile
• GSK Investigational Site — Bacau, Romania
• GSK Investigational Site — Brasov, Romania
• GSK Investigational Site — Brasov, Romania
• GSK Investigational Site — Bucharest, Romania
• GSK Investigational Site — Piteşti, Romania
• GSK Investigational Site — Ploieşti, Romania
• GSK Investigational Site — Ploieşti, Romania
• GSK Investigational Site — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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