A 52-Week, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Safety and Tolerability of GSK573719/GW642444 and GSK573719 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

• Status: Completed
• Trial end date: 2012-07-21
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this 52-week study is to evaluate the long-term safety (in terms of adverse events, COPD exacerbations, laboratory, ECG, and Holter findings, vital signs, use of rescue medication and lung function) of GSK573719/GW642444 Inhalation Powder 125/25mcg in subjects with COPD. The long-term safety of GSK573719 Inhalation Powder 125mcg will also be evaluated. A placebo arm is included to evaluate these products compared to an inactive control.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline

Criteria

Inclusion Criteria:

• 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 greater than or equal to 35% and less than or equal to 80% of predicted normal

Exclusion Criteria:

• Pregant or lactating women or women planning to become 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

• abnormal and clinically significant Holter monitor finding at Visit 1

• significantly abnormal finding from laboratory tests at Visit 1

• unable to withhold albuterol/salbutamol and/or ipratropium bromide 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 within 6 weeks of Visit 1

• use of anitbiotics for lower respiratory tract infection within 6 weeks of Visit 1

• use of cytochrome P450 3A4 inhibitors within 6 weeks of Visit 1

• us of long-acting beta-agonist (LABA)/inhaled corticosteroid (ICS) products if LABA/ICS therapy is discontinued completely within 30 days of Visit 1

• use of ICS at a dose of >10000mcg/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 within 14 days of Visit 1

• use of roflumilast within 14 days of Visit 1

• use of theophyllines within 48 hours of Visit 1

• use of oral leukotriene inhibitors within 48 hours prior to Visit 1

• use of long-acting oral beta-agonists within 48 hours of Visit 1

• use of short-acting oral beta-agonists within 12 hours of Visit 1

• use of inhaled long-acting beta-agonists within 48 hours prior to 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 within 4 hours of Visit 1

• use of inhaled short-acting anticholinergics within 4 hours of Visit 1

• use of inhaled short-acting anticholinergic/short-acting beta2-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) of Visit 1

• long-term oxygen therapy prescribed for >12 hours per day

• regular use of short-acting bronchodilators

• use of CPAP or NIPPV

• participation in the maintenance phase of a pulmonary rehabilitation program

• known or suspected history of alcohol or drug abluse with 2 years prior to Visit 1

• anyone affiliated with the investigator site (e.g., investigator, study coordinator, etc.)

• previous use of GSK573719, GW642444 , GSK573719/GW642444 combination, GSK233705/GW642444 combination, or Fluticasone Furoate/GW642444 combination