This is a multi-center, randomized, placebo-controlled, double blind clinical study to assess the efficacy and safety of two separate dose regimens of Alpha-1 MP versus placebo for 156 weeks (i.e., 3 years) using computed tomography (CT) of the lungs as the main measure of efficacy. The two Alpha-1 MP doses to be tested are 60 mg/kg and 120 mg/kg administered weekly by IV infusion for 156 weeks. The study consists of an optional pre-screening phase, Screening Phase, a 156-week Treatment Phase, and an End of Study Visit at Week 160.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
345
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
University of Florida
Gainesville, Florida, United States
Medical Research of Central Florida, LLC
Leesburg, Florida, United States
University of Miami Miller School of Medicine
Miami, Florida, United States
Washington University School of Medicine
St Louis, Missouri, United States
Change from Baseline in Whole lung PD15 (15th percentile point)
Whole lung PD15 measured by CT scan
Time frame: Week -3 (baseline measure), Week 52, Week 104, Week 130, Week 156
Adverse Events (AEs)
Monitoring of AEs
Time frame: Week -3 through Week 160
Serious Adverse Events (SAEs)
Monitoring of SAEs
Time frame: Week -3 through Week 160
Discontinuations from the study due to AEs
Monitoring of discontinuations due to AEs
Time frame: Week -3 through Week 160
Severe COPD Exacerbations
Severe COPD exacerbations as defined by American Thoracic Society/European Respiratory Society (ATS/ERS) criteria (i.e., COPD exacerbations requiring hospitalization)
Time frame: Week -3 through Week 160
Change from Baseline in PD15 of the basal lung region
PD15 of the basal lung region measure by CT scan
Time frame: Week -3 (baseline measure), Week 52, Week 104, Week 130, Week 156
Change from baseline in carbon monoxide diffusing capacity (DLco)
DLco performed according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines
Time frame: Weeks 26, 52, 78, 104, 130 and 156
Changes from baseline in forced expiratory volume in 1 second (FEV1)
FEV1 performed according to ATS/ERS guidelines
Time frame: Weeks 26, 52, 78, 104, 130 and 156
Change from baseline in Saint George's Respiratory Questionnaire: Minimum value = 0, maximum value = 100, higher scores indicate worse condition
Health-related quality of life assessment tool
Time frame: Weeks 26, 52, 78, 104, 130 and 156
Change from baseline in the EuroQoL (Quality of Life)- 5 Dimension- 5 Level (EQ-5D-5L): Minimum value (for each one of the 5 levels) = 1, maximum value (for each one of the 5 levels) = 5, higher scores indicate worse condition
Heath-related quality of life assessment tool
Time frame: Weeks 26, 52, 78, 104, 130 and 156
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Accellacare
Wilmington, North Carolina, United States
Oregon Health & Science University
Portland, Oregon, United States
Penn State Univ. Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
University of Texas Health Center at Tyler
Tyler, Texas, United States
...and 42 more locations