A two-center, randomized, double-blind, placebo-controlled study of intravenous plasma-purified alpha-1 antitrypsin for hospitalized patients with COPD exacerbations (AECOPD study)
Key facts
- Where
- Pavia és Rozzano, OlaszországSee the 2 sites
- Phase
- 2. fázis
Where in Olaszország
- Fondazione IRCCS Policlinico San MatteoPavia, OlaszországTaking people
- Humanitas Mirasole S.p.A.Rozzano, OlaszországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fondazione IRCCS Policlinico San Matteo
- Trial code
- EU 2024-517613-33-00
- Record updated
- 2025. október 13.
- Original description
to evaluate the safety and efficacy (from a biological perspective) of a single administration of IV Prolastin as an anti-inflammatory treatment for patients admitted to hospital because of a COPD exacerbation leading to an acute or an acute on chronic respiratory failure, by reducing circulating levels of inflammatory markersRead full original descriptionShow less
to evaluate the safety and efficacy (from a biological perspective) of a single administration of IV Prolastin as an anti-inflammatory treatment for patients admitted to hospital because of a COPD exacerbation leading to an acute or an acute on chronic respiratory failure, by reducing circulating levels of inflammatory markers
Inclusion: 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).
Exclusion: 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; 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; Known diagnosis of selective IgA deficiency defined as a serum IgA of less than 7 mg/dl (0.07 g/L); 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).