Immuno-inflammatory Response of Erdosteine in COPD

NCT ID: NCT07329946

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2027-12-31

Brief Summary

Chronic obstructive pulmonary disease (COPD) remains a major contributor to global morbidity and mortality, exposing healthcare systems to a significant economical and social load. Indeed, acute severe COPD exacerbations are the events that contribute most to the overall disease burden. Current management strategies are aimed at maximizing symptom-free periods, reduce hospitalizations, improve exercise tolerance, overall health status, and quality of life. Key pathophysiological mechanisms involved in COPD exacerbations (defined as acute worsening of respiratory symptoms) include oxidative stress, acute on chronic inflammation, and mucus hypersecretion. Agents with antioxidant, anti-inflammatory, and mucolytic properties can help reduce exacerbation frequency. Erdosteine is a new-generation mucoactive molecule developed to overcome the limitations associated with traditional mucolytics. In fact, in addition to its mucolytic effects, erdosteine exhibits antioxidant and anti-inflammatory activities and may reduce bacterial adhesion to airway surfaces - features that may be beneficial in the prevention and management of exacerbations. Preliminary clinical findings (EQUALIFE and RESTORE studies) suggest that erdosteine, in add-on to chronic inhaled therapy, can reduce exacerbation rates, shorten hospital stay, and improve health-related quality of life in patients with COPD. However, studies that have investigated the pathobiological mechanisms behind such clinical effects are lacking.

The present study was constructed in order to investigate the mechanism of action of erdosteine on inflammation, oxidative stress pathways and immune response in patients with COPD. The secondary objectives of the study are to evaluate the effect of erdosteine on lung function tests in patients with COPD; to explore the effect of erdosteine on respiratory and COPD-related symptoms in patients with COPD; to assess the effect of erdosteine on exercise tolerance in patients with COPD. In order to do so, the investigator designed a pragmatic, low intervention, two-arms, monocenter, open-label, prospective, randomized, controlled trial, set in clinical practice. A total of 30 patients will be randomized by means of a 1:1 random allocation.

The active group (15 patients) will be assigned to Treatment Arm A (Erdosteine [Esteclin®] 300 mg, 1 tablet twice daily for 30 days), while the control group (15 patients) will be assigned to Treatment Arm B (Standard of Care - current standard inhalation therapy in use).

Conditions

COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ARM A - Erdosteine treatment

Patients will be randomized to receive Erdosteine \[Esteclin®\] 300 mg, 1 tablet twice daily for 30 days

Group Type: EXPERIMENTAL

Erdosteine

Intervention Type: DRUG

Erdosteine tablets 300 mg, 1 tablet orally every 12 hours (twice daily) for 30 days

Standard of Care (SOC)

Intervention Type: DRUG

Long acting beta-2 agonists and Long acting muscarinic antagonists in association (LABA/LAMA) with or without inhaled corticosteroids (LABA/LAMA/ICS) depending on the chronic inhaled home treatment. Dosage and posology will change depending on the molecules and the devices (once daily in case of umeclidinium bromide/vilanterol 55/22 mcg or fluticasone/umeclidinium bromide/vilanterol 92/55/22 or twice daily in case of budesonide/formoterol/glycopyrronium 160/7.2/4.8 mcg and beclometasone/formoterol/glycopyrronium 87/5/9 mcg)

ARM B - Standard of care

Patients will be randomized to receive current standard inhalation therapy in use

Group Type: PLACEBO_COMPARATOR

Standard of Care (SOC)

Intervention Type: DRUG

Long acting beta-2 agonists and Long acting muscarinic antagonists in association (LABA/LAMA) with or without inhaled corticosteroids (LABA/LAMA/ICS) depending on the chronic inhaled home treatment. Dosage and posology will change depending on the molecules and the devices (once daily in case of umeclidinium bromide/vilanterol 55/22 mcg or fluticasone/umeclidinium bromide/vilanterol 92/55/22 or twice daily in case of budesonide/formoterol/glycopyrronium 160/7.2/4.8 mcg and beclometasone/formoterol/glycopyrronium 87/5/9 mcg)

Interventions

Erdosteine

Erdosteine tablets 300 mg, 1 tablet orally every 12 hours (twice daily) for 30 days

Intervention Type: DRUG

Standard of Care (SOC)

Long acting beta-2 agonists and Long acting muscarinic antagonists in association (LABA/LAMA) with or without inhaled corticosteroids (LABA/LAMA/ICS) depending on the chronic inhaled home treatment. Dosage and posology will change depending on the molecules and the devices (once daily in case of umeclidinium bromide/vilanterol 55/22 mcg or fluticasone/umeclidinium bromide/vilanterol 92/55/22 or twice daily in case of budesonide/formoterol/glycopyrronium 160/7.2/4.8 mcg and beclometasone/formoterol/glycopyrronium 87/5/9 mcg)

Intervention Type: DRUG

Other Intervention Names

Esteclin

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 45 years

2. A confirmed COPD diagnosis at least 12 months prior to 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

Exclusion Criteria

1. NYHA class III and IV heart failure

2. Unstable arrythmia

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pierachille Santus, MD, PhD

OTHER

Sponsor Role: lead

Responsible Party

Pierachille Santus, MD, PhD

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

L. Sacco Hospital

Milan, , Italy

Countries

Italy

Central Contacts

Pierachille Santus Professor, MD, PhD

Role: CONTACT

pierachille.santus@unimi.it

0039 0239042801

Dejan Radovanovic, MD, PhD

Role: CONTACT

dejan.radovanovic@unimi.it

0039 0239042372

Facility Contacts

Pierachille Santus

Role: primary

pierachille.santus@unimi.it

0239042801

Other Identifiers

400.141CRC

Identifier Type: -

Identifier Source: org_study_id