24-week Trial Comparing GSK573719/GW642444 With GW642444 and With Tiotropium in Chronic Obstructive Pulmonary Disease

• Status: Completed
• Trial end date: 2012-04-24
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase III multicenter, randomized, double-blind, double-dummy, parallel-group study to evaluate the efficacy and safety of two doses of GSK573719/GW642444 Inhalation Powder and GW642444 Inhalation Powder via a Novel Dry Powder Inhaler and tiotropium via HandiHaler when administered once-daily over a 24-week treatment period in subjects with chronic obstructive pulmonary disease (COPD). Subjects who meet eligibility criteria at Screening (Visit 1) will complete a 7 to10 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 26 weeks. The primary measure of efficacy is clinic visit trough (pre-bronchodilator and pre-dose) forced expiratory volume in one second (FEV1) on Treatment Day 169. Safety will be assessed by adverse events, 12-lead ECGs, vital signs, and clinical laboratory tests.

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

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Bromides; Tiotropium Bromide

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 of less than or equal to 70% predicted normal values

• score of greater than or equal to 2 on the Modified Medical Resarch Council Dyspnea Scale (mMRC)

Exclusion Criteria:

• women who are pregnant or lactating or are planning on becoming 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

• significantly abnormal finding from laboratory tests at Visit 1

• unable to withhold albuterol/salbutamol 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, antibiotics for lower respiratory tract infection, or cytochrome P450 3A4 inhibitors, within 6 weeks of Visit 1

• use of long-acting beta-agonist (LABA)/inhaled corticosteroid (ICS) product if LABA/ICS therapy is discontinued withing 30 days of Visit 1

• use of ICS at a dose of >1000mcg/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 or roflumilast within 14 days of Visit 1

• use of theophyllines, oral leukotriene inhibitors, long-acting oral beta-agonists, or inhaled long-acting beta-agonists within 48 hours of Visit 1

• short-acting oral beta-agonists within 12 hours of 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, inhaled short-acting anticholinergics, or inhaled short-acting anticholinergic/short-acting beta-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)

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

• regular use of nebulized short-acting bronchodilators

• participation in acute phase of pulmonary rehabilitation program

• known or suspected history of alcohol or drug abse within 2 years prior to Visit 1

• anyone affiliated with the investigator site (e.g., investigator, sub-investigator, study coordinator, employee of a participating investigator or study site, or immediate family member)

• previous exposure to GSK573719, GSK573719/GW642444 combination, GW642444 (vilanterol), or fluticasone furoate/GW642444 combination