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NCT07125664Toborzás még nem indult2. fázis

Intravenous Alpha-1 Antitrypsin for Hospitalized Patients With COPD Exacerbations (AECOPD Study)

A Two-center, Randomized, Double-blind, Placebo-controlled Study of Intravenous Plasma-purified Alpha-1 Antitrypsin for Hospitalized Patients With COPD Exacerbations (AECOPD Study)

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. aug. 24. · Több mint 12 hónapja nem frissült - kérdezd meg a helyszínt, nyitott-e még

Rövid összefoglaló (regiszter, angolul)

Intravenous augmentation therapy with purified preparations of AAT (Alpha1-antitrypsin) derived from human plasma is a well consolidated specific therapeutic option to treat the severe deficient state of AAT. Prolastin is used to restore the balance between AAT and elastases in the lung and consequently to prevent a further deterioration in the pulmonary emphysema. Recently, in patients with COVID-19, without genetically lowered AAT levels with moderate to severe ARDS, treatment with AAT was demonstrated to be safe, feasible, and biochemically efficacious as an anti-inflammatory therapeutic therapy. The aim of the study, based on biological plausibility, is to evaluate the safety and efficacy (from a biological perspective) of the administration of intravenous plasma-purified AAT 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. Thirty-six adult patients hospitalized because of a COPD exacerbation leading to an acute or an acute on chronic respiratory failure will be enrolled by the two sites involved in the study, the Pneumology Unit of Fondazione IRCCS Policlinico San Matteo (Pavia, Italy) and the Pneumology Unit of IRCCS Istituto Clinico Humanitas, Rozzano (Milano, Italy). Participants will be randomized 2:1 in the active treatment group (standard treatment + IV administration of Prolastin) or in the placebo group (standard treatment+ IV administration of 0.9% sodium chloride). To address the clinical question from a biological perspective, we will investigate the decrease in inflammatory markers in the active treated group in comparison with the placebo group. The primary objective is to demonstrate a significant reduction in systemic inflammation by IV Prolastin administered once at 120 mg per kilogram of body weight in patients with moderate to severe AECOPD, as assessed by the change in plasma concentration of IL6 at 7 days after randomization, in the active treatment group with respect to placebo group. Secondary outcomes are: 1. Difference in 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. 2. Differences in AAT antielastase activity, the amount of active elastase, the AAT levels in serum at baseline and at 7 days after randomization. 3. Difference in treatment failure rate. Treatment failure is a composite endpoint of need for either NIV or CPAP or need of ETI or need of transfer to ICU or in-hospital death after randomization 4. Impact of AECOPD on overall health, daily life, and perceived well-being in patients with obstructive airways disease by the change of St. George's Respiratory Questionnaire (SGRQ) score from Day 7 to follow-up (30 days after hospital discharge). 5. Differences in type and number of AEs and SAEs in the two groups The expected duration of subject participation is from randomization to 30 days after hospital discharge, with a follow up phone contact.

Állapot (regiszter)
Toborzás még nem indult
Fázis (regiszter)
2. fázis
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
36 (tervezett)
Első benyújtás
2025. aug. 8.
Kezdés
2025. okt. 1.
Elsődleges befejezés
2027. okt. 7.
Fő szponzor
Fondazione IRCCS Policlinico San Matteo di Pavia
NCT-szám
NCT07125664

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó · 2. fázis
  • Tervezett résztvevők: 36
  • 2025. okt. 1. és az elsődleges befejezés (2027. okt. 7.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

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Korábbi kezelés

  • 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
  • Participants that have previously received Prolastin® 1000 mg/40 ml
  • Participation in another interventional clinical trials with investigational drugs within the 30 days preceding and during the present study. \* A woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Women will be considered postmenopausal if they have been amenorrhoeic for 12 months prior to the randomisation without an alternative medical cause.

Más betegség

  • 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:
    • Affect the safety of the participant throughout the study
    • Influence the findings of the study or their interpretation

Laborértékek

  • Known diagnosis of selective IgA deficiency defined as a serum IgA of less than 7 mg/dl (0.07 g/L)

Egyéb

  • 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
  • Patient with the immediate need for ETI of NIV (patients already on CPAP or NIV can be included)
  • Women who are of childbearing potential\*

Kiket keres a vizsgálat

  • Informed Consent as documented by signature
  • Male and female ≥40 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 respiratory failure with SpO2 \<92% at room air, or PaO2\< 60 mmHg at room air, or acute on chronic respiratory failure defined as higher Increased oxygen requirements compared with the home standard oxygen prescription
  • A positive sputum NEATstik®, that corresponds to an approximate neutrophil elastase concentration of 8 μg·mL-1 (rapid point-of-care test)

Életkor a regiszterben: 40 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
Fondazione IRCCS Policlinico San Matteo
Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát		PaviaOlaszországIsmeretlen állapot

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