Safety and Tolerability of Repeat Dosing of GSK233705/GW642444 in COPD

Completed · Phase 2 · Has a placebo group

Conditions studied: Pulmonary Disease, Chronic Obstructive

In brief

The purpose of this study is the evaluate the safety and tolerability of repeat dosing of the combination of inhaled GSK233705 and GW642444 administered once-daily in subjects with COPD.

Key facts

Study ID

NCT00749411

Run by

GlaxoSmithKline

People needed

61

Starts

2008-11-13

Expected to finish

2009-02-12

Last updated by the study team

2020-09-01

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• male and females 40 to 80 years of age (inclusive)
• COPD diagnosis
• Current or previous smokers with a cigarette smoking history of at least 10 pack-
• Post-albuterol FEV1/FVC of 0.70 or less
• Post-albuterol FEV1 of 35% to 80% (inclusive)

You may not qualify if…

• Pregnant or lactating females
• current diagnosis of asthma
• respiratory disorders other than COPD
• clinically significant cardiovascular, neurological, psychiatric, renal, immunological, endocrine, or hematological abnormalities that are uncontrolled
• clinically significant sleep apnea
• previous lung resection surgery
• clinically significant abnormalities confirmed by chest x-ray that are not related to COPD
• hospitalization for COPD within 3 months of screening
• use of antibiotics for lower respiratory tract infection within 6 months of screening
• abnormal and clinically significant 12-lead ECG findings
• current malignancy in remission for less that 5 years
• medical conditions that would contraindicate the use of anticholinergics
• positive hepatitis B or C test
• history of alcohol or drug abuse
• unable to withhold albuterol for 6 or more hours
• use of long term oxygen therapy
• conditions that would limit the validity of informed consent
• use of GW642444 or GSK233705 in previous studies
• use of an investigation drug with 30 days of screening
• use of inhaled corticosteroids (ICS) at a dose greater than 1000mcg of fluticasone propionate or equivalent
• hypersensitivity to beta-agonists
• concurrent use of long-acting beta-agonists (LABA) or long-acting muscaring antagonists, LABA/ICS combination products, cytochrome p450 inhibitors, oral or depot corticosteroids, theophyllines, oral beta agonists, oral leukotrine modulators, inhaled short acting anticholinergics.

Where it is running

• GSK Investigational Site — Mobile, Alabama, United States
• GSK Investigational Site — Wheat Ridge, Colorado, United States
• GSK Investigational Site — Biddeford, Maine, United States
• GSK Investigational Site — St Louis, Missouri, United States
• GSK Investigational Site — Summit, New Jersey, United States
• GSK Investigational Site — Medford, Oregon, United States
• GSK Investigational Site — Erie, Pennsylvania, United States
• GSK Investigational Site — Greenville, South Carolina, United States
• GSK Investigational Site — Spartanburg, South Carolina, United States
• GSK Investigational Site — Johnson City, Tennessee, United States
• GSK Investigational Site — San Antonio, Texas, United States
• GSK Investigational Site — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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