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Clinical Trials/2025-524821-42-00
2025-524821-42-00RecruitingPhase 4

Erdosteine effect on oxidative stress, inflammatory response and immune modulation in patients with COPD. A single center, open label, double arm, controlled, 4-week, explorative, ex vivo study.

ASST Fatebenefratelli Sacco1 site in 1 country30 target enrollmentStarted: May 3, 2026Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Recruiting
Enrollment
30
Locations
1
Primary Endpoint
Difference from baseline in relative GPX2 (glutathione peroxidase 2) expression and GPX2 enzyme quantification in peripheral blood after 30 days of treatment with erdosteine+ standard of care.
Study OverviewEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

To investigate changes of transcriptomic and secretomic profile of GPX2 (glutathione peroxidase 2) in COPD patients exposed to erdosteine + standard of care.

Eligibility Criteria

Ages
18 years to 65+ years (65+ Years, 18-64 Years)
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Age ≥ 45 years
  • •A spirometrically confirmed COPD diagnosis (post bronchodilator FEV1/FVC <0.7) dating at least 12 months from enrollment
  • •Stable clinical conditions, defined as no exacerbations or respiratory infections of any severity in the last 3 months before enrollment
  • •Moderate to Severe airflow obstruction (FEV1 30-80 %predicted post bronchodilation)
  • •No hospitalizations for any cause in the 3 months prior to enrollment
  • •Ability to perform repeatable pulmonary function tests
  • •Chronic inhaled therapy with LAMA/LABA or LAMA/LABA/ICS with no changes in dosage in the last 3 before enrollment
  • •Ex smokers with a smoking history of at least 10 pack years (1 pack year equals to 20 cigarettes smoked per day per 10 years)
  • •Male or female gender

Exclusion Criteria

  • •NYHA class III and IV heart failure
  • •Chronic renal failure with creatinine clearance <25 mL/min
  • •Active smokers or never smokers
  • •Any signs suggestive or positive history for an active systemic or respiratory infection in the last 3 months prior to screening and enrollment
  • •Ongoing therapy, irrespective of the regimen, with any mucolytic/antioxidant agents, including, but not limited to: erdosteine, N-acetylcysteine, carbo-cysteine, ambroxol, bromhexine.
  • •Known allergy or hypersensitivity to erdosteine or to any component of the study drug
  • •Women of Childbearing Potential (WOCBP)
  • •Unstable arrhythmia
  • •Active malignancy (solid or blood)
  • •Chronic treatment with systemic corticosteroids or immunosuppressants
  • •Immune depression
  • •Known hypersensitivity to erdosteine
  • •Pregnancy or breastfeeding
  • •Active peptic ulcer
  • •Hepatic insufficiency, liver cirrhosis or known cystathionine-synthase deficiency

Arms & Interventions

ESTECLIN 300 MG CAPSULE RIGIDE

Test

Intervention: ESTECLIN 300 MG CAPSULE RIGIDE (Drug)

Outcomes

Primary Outcomes

Difference from baseline in relative GPX2 (glutathione peroxidase 2) expression and GPX2 enzyme quantification in peripheral blood after 30 days of treatment with erdosteine+ standard of care.

Difference from baseline in relative GPX2 (glutathione peroxidase 2) expression and GPX2 enzyme quantification in peripheral blood after 30 days of treatment with erdosteine+ standard of care.

Secondary Outcomes

  • Difference between baseline and end of treatment in relative GPX2 (glutathione peroxidase 2) expression and GPX2 enzyme concentration in peripheral blood in patients exposed to Erdosteine + Standard of Care (Treatment arm A) and patients not exposed to Erdosteine (Treatment arm B).
  • Difference from baseline after 30 days of treatment in relative expression and concentration of immune response pathways related cytokines/chemokines and oxidative stress mediators in peripheral blood of patients exposed to Erdosteine + Standard of Care (Treatment arm A).
  • Difference from baseline after 30 days of treatment in relative expression and concentration of immune response pathways related cytokines/chemokines and oxidative stress mediators in peripheral blood of patients exposed to Erdosteine + Standard of Care (Treatment arm A) compared with patients treated with Standard of Care (Treatment arm B).
  • Difference from baseline after 30 days of treatment in functional characterization by means of flow cytometry of Th 1 (CD4/T-bet/IFN-γ/IL-2), Th 17 (CD4/Rorγt/IL-17/IL-21) and Treg (CD4/C25/Foxp3/IL-10/TGF-β/CTLA-4) in peripheral blood of patients exposed to Erdosteine + Standard of Care (Treatment arm A) compared with patients treated with Standard of Care (Treatment arm B).

Investigators

Sponsor Class
Hospital/Clinic/Other health care facility
Responsible Party
Principal Investigator
Principal Investigator

Principal Investigator

Scientific

ASST Fatebenefratelli Sacco

Study Sites (1)

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