A two-center, randomized, double-blind, placebo-controlled study of intravenous plasma-purified alpha-1 antitrypsin for hospitalized patients with COPD exacerbations (AECOPD study)

Prior treatment

• Participants that have previously received Prolastin® 1000 mg/40 ml
• Participation in another interventional clinical trial with investigational drugs within the 30 days preceding and during the present study
• Current diagnosis of asthma according to the GINA, prior history of asthma, or asthma-COPD overlap
• Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product

Other illness

• Clinically important pulmonary disease other than COPD (e.g., clinically significant bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, and primary ciliary dyskinesia)
• Presence of any active malignancy (other than non-melanoma skin cancer)
• Any unstable disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric disorder, major physical and/or cognitive impairment that, in the opinion of the Investigator, could: (a) Affect the safety of the participant throughout the study (b) Influence the findings of the study or their interpretation

Lab values

• Known diagnosis of selective IgA deficiency defined as a serum IgA of less than 7 mg/dl (0.07 g/L)

Other

• Women who are pregnant or breastfeeding
• Presence of pneumonia or other pleuroparenchymal abnormalities on either chest X-ray or Chest CT scan, performed per routine clinical practice at the hospital admission
• Known AATD as homozygous or composite heterozygous mutation of the AAT gene (patients will be screened for AATD but genetic testing will not be available at enrolment)
• Patient with the immediate need for ETI of NIV (patients already on CPAP or NIV can be included)

• Informed Consent as documented by signature
• Male and female ≥18 years old
• Previous COPD diagnosis with a documented post-bronchodilator FEV1 to FVC ratio (FEV1/FVC) equal to or less than 0.70 or LLN
• Hospitalized for a moderate to severe exacerbation, according to the Rome proposal
• Admission to the respiratory ward by ≤24 hours
• Acute or acute on chronic respiratory failure with SpO2 <92% at room air, or PaO2/FiO2 (or SpO2/FiO2) <300)
• A positive sputum NEATstik®, that corresponds to an approximate neutrophil elastase concentration of 8 μg·mL−1 (rapid point-of-care test)