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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-517613-33-00

Acronym

AECOPD

Enrollment

Registered

2025-03-04

Start date

2025-10-16

Completion date

Unknown

Last updated

2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Brief summary

Change in plasma concentration of IL-6 at 7 days after randomization

Detailed description

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, Treatment failure (need for either NIV or CPAP or ETI or transfer to ICU or in-hospital death after randomization), Differences in SGRQ score at discharge

Interventions

DRUGSodio Cloruro DIACO 0

DRUG9% Soluzione per infusione

DRUGProlastin 1000 mg

DRUGpolvere e solvente per soluzione per infusione

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change in plasma concentration of IL-6 at 7 days after randomization	—

Secondary

Measure	Time frame
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, Treatment failure (need for either NIV or CPAP or ETI or transfer to ICU or in-hospital death after randomization), Differences in SGRQ score at discharge	—

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026