A 24-week Evaluation of GSK573719/Vilanterol (62.5/25mcg) and Components in COPD

Completed · Phase 3 · Has a placebo group

Conditions studied: Pulmonary Disease, Chronic Obstructive

In brief

This is a phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of GSK573719/GW642444 Inhalation Powder, GSK573719 Inhalation Powder, GW642444 Inhalation Powder and Placebo when administered once-daily via a Novel Dry Powder Inhaler over a 24-week treatment period in subjects with COPD. Subjects who meet eligibility criteria at Screening (Visit 1) will complete a 7 to14 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 27 weeks. A subset of subjects at selected sites will also perform 24-hour serial spirometry and Holter monitoring during the study and provide serial blood samples for pharmacokinetic analysis. Sparse pharmacokinetic sampling for population pharmacokinetic analyses will be obtained from non-subset subjects. The primary measure of efficacy is clinic visit trough (pre-bronchodilator and pre-dose) FEV1 on Treatment Day 169. Safety will be assessed by adverse events, 12-lead ECGs, vital signs, clinical laboratory tests, and 24 hour Holter monitoring (subset only).

Key facts

Study ID

NCT01313650

Run by

GlaxoSmithKline

People needed

1538

Starts

2011-03-01

Expected to finish

2012-04-05

Last updated by the study team

2018-08-06

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of COPD
• 10 pack-year or greater history of cigarette smoking
• Post-bronchodilator FEV1/FVC of <0.7
• Predicted FEV1 of 70% of normal or less
• Modified Medical Research Council (mMRC) dyspnea score of 2 or greater

You may not qualify if…

• Women who are pregnant, lactating, or planning to become pregnant
• Respiratory disorders other than COPD, including a current diagnosis of asthma
• Clinically significant non-respiratory diseases or abnormalities that are not adequate controlled
• Significant allergy or hypersensitivity to anticholinergics, beta-agonist, or the excipients of magnesium stereate or lactose used in the inhaler delivery device
• Hospitalization for COPD or pneumonia within 12 weeks prior to screening
• Lung volume reduction surgery within 12 weeks prior to screening
• Abnormal and clinically significant ECG findings at screening
• Clinically significant laboratory findings at screening
• Use of systemic corticosteroids, antibiotics for respiratory tract infections, strong cytochrome P450 3A4 inhibitors, high dose inhaled steroids (>1000mcg fluticasone propionate or equivalent), PDE4 inhibitors, tiotropium, oral beta2-agoinists, short- and long-acting inhaled beta2-agonists, ipratropium, inhaled sodium cromoglycate or nedocromil sodium, or investigational medicines for defined time periods prior to the screening visit
• Use of long-term oxygen therapy (12 hours or greater per day)
• Regular use of nebulized treatment with short-acting bronchodilators
• Participation in the acute phase of a pulmonary rehabilitation program
• A know or suspected history of alcohol or drug abuse
• Affiliation with the investigational site
• Previous use of GSK573719 or GW642444 alone or in combination, including the combination of fluticasone furoate and GW64244

Where it is running

• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Ormond Beach, Florida, United States
• GSK Investigational Site — Tampa, Florida, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Lawrenceville, Georgia, United States
• GSK Investigational Site — Coeur d'Alene, Idaho, United States
• GSK Investigational Site — Lafayette, Indiana, United States
• GSK Investigational Site — Olathe, Kansas, United States
• GSK Investigational Site — Topeka, Kansas, United States
• GSK Investigational Site — Madisonville, Kentucky, United States
• GSK Investigational Site — New Orleans, Louisiana, United States
• GSK Investigational Site — Sunset, Louisiana, United States
• GSK Investigational Site — Cadillac, Michigan, United States
• GSK Investigational Site — St Louis, Missouri, United States
• GSK Investigational Site — Omaha, Nebraska, United States
• GSK Investigational Site — Albuquerque, New Mexico, United States
• GSK Investigational Site — Larchmont, New York, United States
• GSK Investigational Site — Cincinnati, Ohio, United States
• GSK Investigational Site — Cincinnati, Ohio, United States
• GSK Investigational Site — Columbus, Ohio, United States
• GSK Investigational Site — Dayton, Ohio, United States
• GSK Investigational Site — Medford, Oregon, United States
• GSK Investigational Site — Beaver, Pennsylvania, United States
• GSK Investigational Site — Erie, Pennsylvania, United States
• GSK Investigational Site — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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