2024-517613-33-00尚未招募2 期
A two-center, randomized, double-blind, placebo-controlled study of intravenous plasma-purified alpha-1 antitrypsin for hospitalized patients with COPD exacerbations (AECOPD study)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Change in plasma concentration of IL-6 at 7 days after randomization
研究概览
简要总结
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
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Change in plasma concentration of IL-6 at 7 days after randomization
Change in plasma concentration of IL-6 at 7 days after randomization
次要结局
- 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
研究者
Angelo Guido Corsico
Scientific
Fondazione IRCCS Policlinico San Matteo
研究点 (2)
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