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

Completed · Phase 3

Conditions studied: Pulmonary Disease, Chronic Obstructive

In brief

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.

Key facts

Study ID: NCT01316913
Run by: GlaxoSmithKline
People needed: 872
Starts: 2011-03-01
Expected to finish: 2012-04-01
Last updated by the study team: 2017-04-04

Who can join

Age: 40 and older. 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 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
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

Where it is running

GSK Investigational Site — Mobile, Alabama, United States
GSK Investigational Site — Huntington Beach, California, United States
GSK Investigational Site — Los Angeles, California, United States
GSK Investigational Site — Clearwater, Florida, United States
GSK Investigational Site — Ormond Beach, Florida, United States
GSK Investigational Site — Lawrenceville, Georgia, United States
GSK Investigational Site — Topeka, Kansas, United States
GSK Investigational Site — Madisonville, Kentucky, United States
GSK Investigational Site — Lafayette, Louisiana, United States
GSK Investigational Site — New Orleans, Louisiana, United States
GSK Investigational Site — St Louis, Missouri, United States
GSK Investigational Site — Charlotte, North Carolina, United States
GSK Investigational Site — Elizabeth City, North Carolina, United States
GSK Investigational Site — Cincinnati, Ohio, United States
GSK Investigational Site — Medford, Oregon, United States
GSK Investigational Site — Beaver, Pennsylvania, United States
GSK Investigational Site — Easley, South Carolina, United States
GSK Investigational Site — Spartanburg, South Carolina, United States
GSK Investigational Site — Morgantown, West Virginia, United States
GSK Investigational Site — Buenos Aires, Buenos Aires, Argentina
GSK Investigational Site — Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
GSK Investigational Site — Mendoza, Mendoza Province, Argentina
GSK Investigational Site — Buenos Aires, Argentina
GSK Investigational Site — Buenos Aires, Argentina
GSK Investigational Site — Jasper, Alabama, United States

Full record on ClinicalTrials.gov

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