Immuno-inflammatory Response of Erdosteine in COPD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Erdosteine, Standard of Care (SOC).
- Who it may be relevant to
- Registry conditions: COPD. Basic parameters: from 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
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).
Interventions
- Drug Erdosteine
Erdosteine tablets 300 mg, 1 tablet orally every 12 hours (twice daily) for 30 days - 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/formoter
Primary outcome measures
- Changes in transcriptomics of pro-inflammatory and anti-inflammatory cytokines in COPD patients exposed to erdosteine. [Time frame: 4 weeks]
- Changes in transcriptomics of oxidative stress signaling pathways in COPD patients exposed to erdosteine. [Time frame: 4 weeks]
Secondary outcome measures (3)
- To assess the effect of erdosteine on mMRC dyspnea scale in patients with COPD [Time frame: 4 weeks]
- To assess the effect of erdosteine on distance covered during the six minute walk test in patients with COPD [Time frame: 4 weeks]
- To assess the effect of erdosteine on CAT (COPD assessment test) in patients with COPD [Time frame: 4 weeks]
Eligibility criteria
Inclusion criteria
- Age ≥ 45 years
- A confirmed COPD diagnosis at least 12 months prior to 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
Exclusion criteria
- NYHA class III and IV heart failure
- Unstable arrythmia
- Active malignancy (solid or blood)
- Chronic treatment with systemic corticosteroids or immunosuppressants
- Immune depression
- Known hypersensitivity to erdosteine
- Pregnancy or breastfeeding
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- L. Sacco Hospital — Milan
Identifiers
NCT: NCT07329946 · 400.141CRC