To demonstrate the additional benefit of roflumilast when added on to fixed-dose combination (FDC) LABA/ICS in the reduction of exacerbations in subjects with severe to very severe COPD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
2,354
Roflumilast 500 µg, oral administration, once per day
Dose-matched placebo, oral administration, once per day.
Forest Investigative Site 081
Anniston, Alabama, United States
Forest Investigative Site 065
Athens, Alabama, United States
Forest Investigative Site 131
Florence, Alabama, United States
Forest Investigative Site 073
Mobile, Alabama, United States
Forest Investigative Site 272
Mesa, Arizona, United States
Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year.
Rate of moderate or severe COPD exacerbations, defined as requiring oral or parenteral glucocorticosteroids (moderate) or requiring hospitalization and/or leading to death (severe), during the double-blind treatment period.
Time frame: Baseline to Week 52
Rate of COPD Exacerbations That Led to Hospitalization or Death (ie, Severe COPD Exacerbations)
Rate of moderate or severe COPD exacerbations, defined as requiring hospitalization and/or leading to death (severe), during the double-blind treatment period.
Time frame: Week 0 (Visit 2) to Week 52
Rate of Moderate or Severe COPD Exacerbations or COPD Exacerbations Treated With Antibiotics
Rate of moderate or severe COPD exacerbations treated with antibiotics during the double-blind treatment period.
Time frame: Week 0 (Visit 2) to Week 52
Mean Change in Predose Forced Expiratory Volume in 1 Second (FEV1)
Mean change from randomization (Visit 2) over 52 weeks of treatment in predose forced expiratory volume in 1 second (FEV1)
Time frame: Week 0 (Visit 2) to Week 52
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Forest Investigative Site 091
Peoria, Arizona, United States
Forest Investigative Site 034
Phoenix, Arizona, United States
Forest Investigative Site 188
Phoenix, Arizona, United States
Forest Investigative Site 211
Phoenix, Arizona, United States
Forest Investigative Site 247
Phoenix, Arizona, United States
...and 328 more locations