Immuno-inflammatory Response of Erdosteine in COPD

Conditions

• COPD

Eligibility Criteria

Sex

ALL

Age

45 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Erdosteine — DRUG
  Erdosteine tablets 300 mg, 1 tablet orally every 12 hours (twice daily) for 30 days
• Standard of Care (SOC) — 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)

Study Details

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).

Key Dates

First listed

Jan 9, 2026

Start date

Sep 1, 2026

Status verified

Apr 2026

Primary completion

Feb 28, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

30 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: ARM A - Erdosteine treatment
  Patients will be randomized to receive Erdosteine \[Esteclin®\] 300 mg, 1 tablet twice daily for 30 days
• Placebo Comparator: ARM B - Standard of care
  Patients will be randomized to receive current standard inhalation therapy in use

Primary Outcome Measure

Changes in transcriptomics of pro-inflammatory and anti-inflammatory cytokines in COPD patients exposed to erdosteine. [ Time Frame: 4 weeks ]

Central Contacts

• Pierachille Santus Professor, MD, PhD
  0039 0239042801
  [email protected]
• Dejan Radovanovic, MD, PhD
  0039 0239042372
  [email protected]

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