Status:
COMPLETED
Safety and Tolerability of Repeat Dosing of GSK233705/GW642444 in COPD
Lead Sponsor:
GlaxoSmithKline
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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.
Key Trial Info
Start Date :
November 13 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 12 2009
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00749411
Start Date
November 13 2008
End Date
February 12 2009
Last Update
September 1 2020
Active Locations (12)
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1
GSK Investigational Site
Mobile, Alabama, United States, 36608
2
GSK Investigational Site
Wheat Ridge, Colorado, United States, 80033
3
GSK Investigational Site
Biddeford, Maine, United States, 04005
4
GSK Investigational Site
St Louis, Missouri, United States, 63141