This is a Phase IIb, randomized, double blind, chronic dosing (28 days), four period, five treatment, incomplete block, crossover design in subjects with moderate to severe COPD. The overall objective is to demonstrate that the combination of budesonide (BD; PT008) and formoterol fumarate (FF; PT005) in a metered-dose inhaler (MDI); (BFF MDI; PT009) provides benefit on lung function compared with BD MDI in subjects with moderate to severe COPD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
180
Budesonide and formoterol fumarate metered dose inhaler (BFF MDI) 320/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID)
Budesonide and formoterol fumarate metered dose inhaler (BFF MDI) 160/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID)
Budesonide and formoterol fumarate metered dose inhaler (BFF MDI) 80/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID)
Pearl Investigative Site
Rolling Hills Estates, California, United States
Pearl Investigative Site
Clearwater, Florida, United States
FEV1 AUC0-12 on Day 29
Change from Baseline in forced expiratory volume in 1 second (FEV1) area under the curve from 0 to 12 hours (AUC0-12)
Time frame: Day 29
Change From Baseline in Morning Pre-dose Trough FEV1 Over 28 Days
Time frame: Over 28 days
Peak Change From Baseline in FEV1 (in Liters) Day 15
Time frame: Day 15
Peak Change From Baseline in FEV1 (in Liters) Day 29
Time frame: Day 29
Peak Change From Baseline in FEV1 on Day 1
Time frame: Day 1
Forced Vital Capacity (FVC) AUC0-12 on Day 29
Time frame: Day 29
Transition Dyspnea Index (TDI) Focal Score on Day 29
Min/Max Range of TDI scale -9 (major deterioration) to +9 (major improvement)
Time frame: Day 29
Change From Baseline in Average Daily Use of Rescue Ventolin HFA Over the Last Week of Treatment
Time frame: Visit 12-13 (7 days)
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Budesonide metered dose inhaler (BD MDI) 320 μg; PT008 administered as 2 inhalations, twice daily (BID)
Formoterol fumarate metered dose inhaler (FF MDI) 9.6 μg; PT005 administered as 2 inhalations, twice daily (BID)
Pearl Investigative Site
Panama City, Florida, United States
Pearl Investigative Site
Tampa, Florida, United States
Pearl Investigative Site
Winter Park, Florida, United States
Pearl Investigative Site
Edina, Minnesota, United States
Pearl Investigative Site
Minneapolis, Minnesota, United States
Pearl Investigative Site
Woodbury, Minnesota, United States
Pearl Investigative Site
Saint Charles, Missouri, United States
Pearl Investigative Site
Charlotte, North Carolina, United States
...and 7 more locations