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

• Status: Completed
• Trial end date: 2009-02-12
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Muscarinic Antagonists

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.