HUMAN ALPHA1-PROTEINASE INHIBITOR for Chronic Obstructive Pulmonary Disease | COPD exacerbation

Inclusion criteria

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

Exclusion criteria

• {"criterion_text":"- 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)\n- Women who are pregnant or breastfeeding\n- Participants that have previously received Prolastin® 1000 mg/40 ml\n- Participation in another interventional clinical trial with investigational drugs within the 30 days preceding and during the present study\n- 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\n- Current diagnosis of asthma according to the GINA, prior history of asthma, or asthma-COPD overlap\n- 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)\n- Presence of any active malignancy (other than non-melanoma skin cancer)\n- 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\n- Known diagnosis of selective IgA deficiency defined as a serum IgA of less than 7 mg/dl (0.07 g/L)\n- Patient with the immediate need for ETI of NIV (patients already on CPAP or NIV can be included)\n- Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product"}

Primary endpoints

• {"endpoint_text":"- Change in plasma concentration of IL-6 at 7 days after randomization","definition_or_measurement_approach":"Plasma concentration of IL-6 measured at 7 days after randomization."}

Secondary endpoints

• {"endpoint_text":"- Change in plasma concentration of IL-1b, IL-5, IL-8, IL-10, and soluble TNF receptor 1(sTNFR1), CRP at 7 days after randomization","definition_or_measurement_approach":"Plasma concentrations of listed cytokines and CRP measured at 7 days after randomization."}
• {"endpoint_text":"- Treatment failure (need for either NIV or CPAP or ETI or transfer to ICU or in-hospital death after randomization)","definition_or_measurement_approach":"Composite clinical outcome assessed by occurrence of need for NIV or CPAP or endotracheal intubation (ETI), transfer to ICU, or in-hospital death after randomization."}
• {"endpoint_text":"- Differences in SGRQ score at discharge","definition_or_measurement_approach":"Change/differences in St George's Respiratory Questionnaire (SGRQ) score assessed at discharge."}

Italy

Earliest CTIS Part Ii Submission Date

06-02-2025

Latest Decision Or Authorization Date

13-10-2025

Processing Time Days

249

Number Of Sites

2

Number Of Participants

36

Primary sponsor

Full Name

Fondazione IRCCS Policlinico San Matteo

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy