Last updated on November 2017

A Randomized, Double-Blind, Multi-Center, Parallel Group Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 on COPD Exacerbations over a 52-Week Treatment Period in Subjects With Moderate to Very Severe COPD


Brief description of study

A Randomized, Double-Blind, Multi-Center, Parallel Group Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 on COPD Exacerbations over a 52-Week Treatment Period in Subjects With Moderate to Very Severe COPD

Detailed Study Description

This is a randomized, double-blind, multi-center, parallel group study to assess the efficacy and safety of BGF MDI 320/14.4/9.6 μg and BGF MDI 160/14.4/9.6 μg relative to GFF MDI 14.4/9.6 μg and BFF MDI 320/9.6 μg over a 52-week treatment period in 8,000 subjects with moderate to very severe COPD with an increased risk of experiencing a COPD exacerbation and that remain symptomatic (CAT ≥ 10) on two or more inhaled maintenance treatments. There will be a blinded sample size reassessment where the underlying rate of moderate or severe COPD exacerbations and negative binomial shape parameter will be predicted and the sample size potentially increased (but not decreased). The increase in sample size will be capped at 4,000 subjects, such that the total number of randomized subjects will not exceed 12,000. The sample size reassessment will be conducted prior to the first interim analysis.

Clinical Study Identifier: TX5874

.

Contact Investigators or Research Sites near you

Start Over

Please choose location

View all locations

Southeast Regional Research Group - ...

Southeast Regional Research Group - Savannah
Rincon, GA USA
  Connect »

Columbus Regional Research Institute

Columbus Regional Research Institute
Columbus, GA USA
  Connect »

Diana Del Valle

New Horizon Research Center
Miami, FL USA
  Connect »