The overall objective of this study is to assess the efficacy and safety of treatment with PT003 (GFF MDI), PT005 (FF MDI), PT001 (GP MDI), and open-label tiotropium bromide inhalation powder compared with each other and Placebo MDI over 24 weeks in subjects with moderate to very severe COPD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
2,103
Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24
Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) at Week 24
Time frame: Baseline and at Week 24
Change From Baseline in Morning Pre-dose Trough FEV1 Over 24 Weeks
Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) over 24 weeks. FEV1 was assessed at multiple time points post-baseline,and a modelbased average of all visits starting from Week 2 through week 24 inclusive was calculated. The change values reported in the table represent the change between the baseline and the average FEV1 post-baseline.
Time frame: Baseline and Weeks 2 to 24
St. George's Respiratory Questionnaire (SGRQ) Score
Change from baseline in the SGRQ total score. The SGRQ is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of GFF MDI, FF MDI and GP MDI on health-related quality of life as compared to placebo in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life.
Time frame: Baseline and at Week 24
Rescue Ventolin Hydrofluoroalkane (HFA) Use
Change from baseline in average daily rescue Ventolin HFA use
Time frame: Baseline and at Week 24
Onset of Action as Assessed by FEV1
Defined as the first time-point using the 5- and 15-minute post dose measurements where the difference in FEV1 from Placebo was statistically significant
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Taken as 1 capsule daily containing 18 µg of open-label tiotropium via the Handihaler dry powder inhaler (DPI)
Inhaled placebo administered as two puffs BID
Pearl Investigative Site
Andalusia, Alabama, United States
Pearl Investigative Site
Anniston, Alabama, United States
Pearl Investigative Site
Athens, Alabama, United States
Pearl Investigative Site
Birmingham, Alabama, United States
Pearl Investigative Site
Mesa, Arizona, United States
Pearl Investigative Site
Phoenix, Arizona, United States
Pearl Investigative Site
Scottsdale, Arizona, United States
Pearl Investigative Site
Tucson, Arizona, United States
Pearl Investigative Site
Anaheim, California, United States
Pearl Investigative Site
Carlsbad, California, United States
...and 129 more locations
Time frame: Assessed for 5- and 15-minute post dose on Day 1
Peak Change From Baseline in FEV1 Within 2 Hours Post-dose
Peak change from baseline in forced expiratory volume in 1 second (FEV1) within 2 hours post-dose
Time frame: Baseline and at Week 24