A Randomized, Double-Blind, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT009 Compared to PT005 on COPD Exacerbations Over a 52-Week Treatment Period in Subjects With Moderate to Very Severe COPD
A Randomized, Double-Blind, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT009 Compared to PT005 on COPD Exacerbations Over a 52-Week Treatment Period in Subjects With Moderate to Very Severe COPD
This is a Phase III randomized, double-blind, parallel group, multi-center, 52-week COPD exacerbation and lung function study with PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6 μg, all administered BID.
This is a Phase III randomized, double-blind, parallel group, multi-center, 52-week COPD exacerbation and lung function study. Subjects will undergo a 1- to 4-week Screening Period. Subjects who successfully complete the Screening Period will be randomized to one of the following three treatment groups: PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6 μg, all administered BID. Following randomization, subjects will enter the Treatment Period and undergo additional treatment visits over 52 weeks.
Inclusion Criteria:
Exclusion Criteria:
CABA, 1426, Argentina
CABA, C1056ABJ, Argentina
CABA, C1425BEN, Argentina
CABA, Argentina
Ciudad Autonomade Buenos Aires, 1426, Argentina
Ciudad Autónoma de Buenos Aire, C1440BRR, Argentina
Ciudad de Buenos Aires, 1425, Argentina
Rodgau-Dudenhofen, 63110, Germany
Kråkeroy, N-1671, Norway
StPetersburg, 191180, Russia
Lenasia Ext8, 1820, South Africa