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A two-center, randomized, double-blind, placebo-controlled study of intravenous plasma-purified alpha-1 antitrypsin for hospitalized patients with COPD exacerbations (AECOPD study)
EU CTIS ID: 2024-517613-33-00
What this study is testing
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
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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)
You likely can't join if
- 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)
- Women who are pregnant or breastfeeding
- 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
- 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
- Current diagnosis of asthma according to the GINA, prior history of asthma, or asthma-COPD overlap
See the full eligibility criteria
- 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)
- 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)
- Women who are pregnant or breastfeeding
- 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
- 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
- Current diagnosis of asthma according to the GINA, prior history of asthma, or asthma-COPD overlap
- 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)
- 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)
- Patient with the immediate need for ETI of NIV (patients already on CPAP or NIV can be included)
- Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.