Immuno-inflammatory Response of Erdosteine in COPD

Pierachille Santus, MD, PhD

Status: Begins enrollment this month

Conditions: COPD

Treatments: Drug: Standard of Care (SOC); Drug: Erdosteine

Study type: Interventional

Funder types: Other

Identifiers

NCT07329946

400.141CRC

Details and patient eligibility

About

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).

Enrollment: 30 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups, including a placebo group

ARM A - Erdosteine treatment

Experimental group

Description:

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

Treatment:

Drug: Erdosteine

Drug: Standard of Care (SOC)

ARM B - Standard of care

Placebo Comparator group

Description:

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

Treatment:

Drug: Standard of Care (SOC)