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Study of alpha-1 antitrypsin given intravenously to hospitalized patients during COPD exacerbation

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with Chronic Obstructive Pulmonary Disease (COPD) who are hospitalized due to worsening of their condition, known as COPD exacerbation. The study will test a medication called Prolastin, which contains a protein called alpha-1 antitrypsin that is naturally present in the human body. The purpose is to determine if this medication can help reduce inflammation in patients experiencing severe COPD symptoms requiring hospital care.

The treatment involves receiving a single dose of Prolastin or placebo through an intravenous infusion (directly into a vein). The medication will be given along with a standard salt solution (sodium chloride). Patients will be monitored for 7 days after receiving the treatment to see how their body responds, particularly regarding inflammation levels in their blood.

This is a double-blind study, which means neither the patients nor their doctors will know who receives the actual medication and who receives the placebo. The study will measure various markers of inflammation in the blood and track how patients feel during their hospital stay. The treatment's effects will be evaluated through blood tests and assessment of breathing difficulties.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment and qualification
If you have been hospitalized for COPD (Chronic Obstructive Pulmonary Disease) worsening within the last 24 hours, your eligibility for the study will be evaluated
A breathing test will be performed to confirm oxygen levels are below 92% in room air
A quick test using NEATstik® will be done on your sputum sample
Step 2
Random assignment to treatment groups
You will be randomly assigned to receive either the study medication (Prolastin) or placebo (salt solution)
Neither you nor your doctor will know which treatment you are receiving
Step 3
Treatment administration
You will receive a single dose of medication through an intravenous infusion (directly into your vein)
The treatment consists of either Prolastin 1000 mg or a salt solution
Step 4
Monitoring and follow-up
Blood samples will be taken to measure inflammation markers on day 1 and day 7
Your health status will be monitored throughout your hospital stay
You will complete a health questionnaire (SGRQ) before leaving the hospital
Step 5
Study completion
The study ends after the day 7 blood test and completion of the health questionnaire
Your participation will help evaluate if Prolastin can reduce inflammation in COPD patients

Who can join the trial?

8 criteria

Must sign an informed consent document
Must be at least 18 years old (both men and women can participate)
Must have a previous diagnosis of COPD with documented breathing test results showing a FEV1/FVC ratio of 0.70 or less (This is a measure of lung function where FEV1 is how much air you can forcefully exhale in one second, and FVC is the total amount of air you can exhale)
Must be currently hospitalized for a moderate to severe COPD exacerbation (worsening of symptoms)
Must have been admitted to the respiratory ward within the last 24 hours
Must have breathing difficulties shown by either:
- Blood oxygen level (SpO2) less than 92% when breathing regular room air, or
- Oxygen exchange measurement (PaO2/FiO2 or SpO2/FiO2) less than 300
- Must have a positive result on a sputum NEATstik® test (a quick test that measures certain inflammatory substances in mucus from the lungs)

Who cannot join the trial?

15 criteria

Age below 18 years old or above 65 years old
Known allergy or sensitivity to Prolastin or similar medications
Current pregnancy or breastfeeding
Active infection other than COPD exacerbation
History of severe allergic reactions to medications
Severe liver disease or dysfunction
Severe kidney disease or dysfunction
Active cancer or ongoing cancer treatment
Blood clotting disorders
Recent major surgery (within last 3 months)
Participation in another clinical trial within the last 30 days
Inability to provide informed consent
History of organ transplantation
Severe heart disease or recent heart attack
Unstable medical conditions that could interfere with the study

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Verified sites

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Fondazione IRCCS Policlinico San Matteo
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Pavia, Italy
IRCCS Humanitas Research Hospital
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Rozzano, Italy

Trial locations

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Investigated drugs

Prolastin (alpha-1 antitrypsin) is a protein derived from human blood plasma that helps protect body tissues from damage caused by inflammation. In this trial, it is given intravenously to patients during COPD (Chronic Obstructive Pulmonary Disease) flare-ups. The medication works as an anti-inflammatory treatment, aiming to reduce inflammation markers in the blood and potentially help patients recover from severe COPD episodes that require hospitalization.

What is already known about the treatment

Prolastin - An intravenous medication containing plasma-purified alpha-1 antitrypsin, which is primarily used in treating Chronic Obstructive Pulmonary Disease (COPD) exacerbations. This medication belongs to the class of protease inhibitors and works by reducing inflammation in the airways by blocking harmful enzymes that can damage lung tissue. It is administered through intravenous infusion in hospital settings during acute COPD flare-ups, particularly when patients experience respiratory failure, and has shown promise in reducing inflammatory markers in the bloodstream. The medication is derived from human plasma and has been studied in clinical trials for its anti-inflammatory properties in treating severe COPD episodes.

Investigated diseases

Chronic Obstructive Pulmonary Disease - A progressive lung condition that causes breathing difficulties due to narrowed airways and damaged lung tissue. The disease typically develops slowly over many years, causing increasing shortness of breath, persistent cough with mucus production, and wheezing. During the course of the disease, patients may experience periods of sudden worsening of symptoms called exacerbations. The condition affects the normal airflow in and out of the lungs, making it increasingly difficult to breathe normally. Air pollution, smoking, and exposure to certain workplace dust and chemicals are common factors in its development.