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.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

ASST Fatebenefratelli Sacco

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Decision date (initial)

2026-05-20

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2025-524821-42-00

ClinicalTrials.gov

NCT07329946

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Therapy

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

Secondary objectives 4

1. To investigate the difference of transcriptomic and secretomic profile of GPX2 in COPD patients treated with Erdosteine + standard of care. compared with patients treated with standard of care.
2. To investigate the transcriptomic and secretomic profile of immune response cytokine/chemokines and oxidative stress mediators in patients treated with erdosteine + standard of care.
3. To investigate the transcriptomic and secretomic profile of immune response cytokine/chemokines and oxidative stress mediators in patients treated with erdosteine + standard of care compared with standard of care.
4. To investigate the T cell functional characterization (Th1, Th17, Treg) in patients treated with erdosteine + standard of care compared with standard of care.

Conditions and MedDRA coding

COPD

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Age ≥ 45 years
2. A spirometrically confirmed COPD diagnosis (post bronchodilator FEV1/FVC <0.7) dating at least 12 months from enrollment
3. Stable clinical conditions, defined as no exacerbations or respiratory infections of any severity in the last 3 months before enrollment
4. Moderate to Severe airflow obstruction (FEV1 30-80 %predicted post bronchodilation)
5. No hospitalizations for any cause in the 3 months prior to enrollment
6. Ability to perform repeatable pulmonary function tests
7. Chronic inhaled therapy with LAMA/LABA or LAMA/LABA/ICS with no changes in dosage in the last 3 before enrollment
8. 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)
9. Male or female gender

Exclusion criteria 15

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 4

1. 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).
2. 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).
3. 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).
4. 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).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

ASST Fatebenefratelli Sacco

Sponsor organisation

ASST Fatebenefratelli Sacco

Address

Via Giovanni Battista Grassi 74

City

Milan

Postcode

20157

Country

Italy

Scientific contact point

Organisation

ASST Fatebenefratelli Sacco

Contact name

Principal Investigator

Public contact point

Organisation

ASST Fatebenefratelli Sacco

Contact name

Principal Investigator

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications