COPDNCT07329946
Immuno-inflammatory Response of Erdosteine in COPD
A study testing Erdosteine in people with COPD, run by Pierachille Santus, MD, PhD at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Erdosteine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
L. Sacco Hospital
Milan, 20157
Pierachille Santus, 0239042801, pierachille.santus@unimi.it
About this study
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."
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
- Being tested
- Erdosteine, Standard of Care (SOC)
- Keywords
- COPD, ERDOSTEINE
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErdosteineDrug
Also called Esteclin
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 group | Role | What they receive |
|---|---|---|
| ARM A - Erdosteine treatment | Experimental | Patients will be randomized to receive Erdosteine [Esteclin®] 300 mg, 1 tablet twice daily for 30 days Receives: Drug: Erdosteine; Drug: Standard of Care (SOC) |
| ARM B - Standard of care | Placebo comparator | Patients will be randomized to receive current standard inhalation therapy in use Receives: Drug: Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in transcriptomics of pro-inflammatory and anti-inflammatory cytokines in COPD patients exposed to erdosteine.
Peripheral blood will be analyzed for immunological profiling in patients treated with standard of care only and patients also exposed to Erdosteine at baseline and after 4 weeks of treatment. Cytokine/chemokine profiles will be quantified in cell culture supernatants using the Bio-Plex Pro Human Cytokine 27-plex Assay. RNA extraction from whole blood will be performed to identify expression levels of molecules involved in immune response: CARD6, CASP1, CASP4, CCL2, HLA-A, IFITM1, IFNA1, IFNAR1, IL1β, IL6, IL8, IL10, IL17, IL18, IL22, ISG20, TGF-β, NLRP3, NLRP4, VCAM1. Betaactin (ACTB) and glyceraldeyde-3-phosphate dehydrogenase (GAPDH) will be used as housekeeping genes. The results for the gene expression analyses will be presented as the average of the relative expression units (%) to an internal reference sample and normalized to the housekeeping genes GAPDH and ACTB.
Measured: 4 weeks
Changes in transcriptomics of oxidative stress signaling pathways in COPD patients exposed to erdosteine.
Peripheral blood will be analyzed for oxidative stress profiling in patients treated with standard of care only and patients also exposed to Erdosteine at baseline and after 4 weeks of treatment. Oxidative stress will be quantified in cell culture supernatants using the Bio-Plex Pro Human Cytokine 27-plex Assay. RNA extraction from whole blood will be performed to identify expression levels of molecules involved in oxidative stress: APOE, CAT, DUSP1, GPX2, GPX3, MPO, NOS2, NOX4, NUDT1, SOD2. Betaactin (ACTB) and glyceraldeyde-3-phosphate dehydrogenase (GAPDH) will be used as housekeeping genes. The results for the gene expression analyses will be presented as the average of the relative expression units (%) to an internal reference sample and normalized to the housekeeping genes GAPDH and ACTB.
Measured: 4 weeks
Secondary outcomes (3)
To assess the effect of erdosteine on mMRC dyspnea scale in patients with COPD
Patiens will undergo the Modified British Medical Research Council Questionnaire (mMRC) at baseline and after 4 weeks of treatment with erdosteine or placebo.
Modified British Medical Research Council Questionnaire (mMRC) assesses the patient's degree of chronic dyspnea with a score ranging from 0 (no dyspnea) to 4 (too much dyspnea to leave the house). The results will be expressed as absolute and relative difference in dyspnea score.
Measured: 4 weeks
To assess the effect of erdosteine on distance covered during the six minute walk test in patients with COPD
Patiens will undergo the Six Minutes Walk Test (6MWT) at study enrolment and after 4 weeks of treatment with erdosteine or placebo.
The 6MWT will be conducted according to the 2002 American Thoracic Society (ATS) statement. For patients requiring exertional oxygen therapy, the test will be performed with supplemental oxygen. Patients will be asked to walk for 6 minutes on a flat surface, wearing a pulse oximeter. Before starting, the following parameters will be recorded: perceived dyspnoea level using the Borg scale (0-10 score), peripheral oxygen saturation (SpO2), heart rate (beats/min), and respiratory rate (breaths/min). The same parameters will be measured again at the end of the test. The distance walked, and any exercise-induced desaturation (SpO2 drop ≥4 points) will also be noted. The distance covered at the 6MWT will be measured in meters, and results will be expressed as absolute and relative difference from baseline.
Measured: 4 weeks
To assess the effect of erdosteine on CAT (COPD assessment test) in patients with COPD
Patiens will undergo the CAT (COPD assessment test) at baseline and after 4 weeks of treatment with erdosteine or placebo.
COPD assessment test (CAT) aims to assess the impact of COPD on health status through a patient-completed questionnaire consisting of 8 items, each scored from 0 to 5. The total score ranges from 0 to 40, with higher scores indicating a greater impact of the disease on the patient's quality of life. The results will be expressed as absolute and relative difference in CAT total score.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start1 Sep 2026 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pierachille Santus, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pierachille Santus, MD, PhD, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07329946
- Sponsor's protocol ID
- 400.141CRC
- Status last verified
- Apr 2026
- First submitted
- 10 Dec 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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."
- ClinicalTrials.gov ID
- NCT07329946
- Acronym / sponsor ID
- 400.141CRC
- Conditions
- COPD
- Keywords
- COPD, ERDOSTEINE
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Pierachille Santus, MD, PhDUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM A - Erdosteine treatment | Experimental | Drug: Erdosteine, Drug: Standard of Care (SOC)Patients will be randomized to receive Erdosteine [Esteclin®] 300 mg, 1 tablet twice daily for 30 days |
| ARM B - Standard of care | Placebo comparator | Drug: Standard of Care (SOC)Patients will be randomized to receive current standard inhalation therapy in use |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- NYHA class III and IV heart failure
- Unstable arrythmia
- Active malignancy (solid or blood)
- Chronic treatment with systemic corticosteroids or immunosuppressants
- Immune depression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ErdosteineAlso: EsteclinErdosteine tablets 300 mg, 1 tablet orally every 12 hours (twice daily) for 30 days | Drug | ARM A - Erdosteine treatment |
| 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) | Drug | ARM A - Erdosteine treatment, ARM B - Standard of care |
Primary outcome
Changes in transcriptomics of pro-inflammatory and anti-inflammatory cytokines in COPD patients exposed to erdosteine.
Time frame: 4 weeks
Peripheral blood will be analyzed for immunological profiling in patients treated with standard of care only and patients also exposed to Erdosteine at baseline and after 4 weeks of treatment. Cytokine/chemokine profiles will be quantified in cell culture supernatants using the Bio-Plex Pro Human Cytokine 27-plex Assay. RNA extraction from whole blood will be performed to identify expression levels of molecules involved in immune response: CARD6, CASP1, CASP4, CCL2, HLA-A, IFITM1, IFNA1, IFNAR1, IL1β, IL6, IL8, IL10, IL17, IL18, IL22, ISG20, TGF-β, NLRP3, NLRP4, VCAM1. Betaactin (ACTB) and glyceraldeyde-3-phosphate dehydrogenase (GAPDH) will be used as housekeeping genes. The results for the gene expression analyses will be presented as the average of the relative expression units (%) to an internal reference sample and normalized to the housekeeping genes GAPDH and ACTB.
Changes in transcriptomics of oxidative stress signaling pathways in COPD patients exposed to erdosteine.
Time frame: 4 weeks
Peripheral blood will be analyzed for oxidative stress profiling in patients treated with standard of care only and patients also exposed to Erdosteine at baseline and after 4 weeks of treatment. Oxidative stress will be quantified in cell culture supernatants using the Bio-Plex Pro Human Cytokine 27-plex Assay. RNA extraction from whole blood will be performed to identify expression levels of molecules involved in oxidative stress: APOE, CAT, DUSP1, GPX2, GPX3, MPO, NOS2, NOX4, NUDT1, SOD2. Betaactin (ACTB) and glyceraldeyde-3-phosphate dehydrogenase (GAPDH) will be used as housekeeping genes. The results for the gene expression analyses will be presented as the average of the relative expression units (%) to an internal reference sample and normalized to the housekeeping genes GAPDH and ACTB.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erdosteine in people with COPD, run by Pierachille Santus, MD, PhD at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pierachille Santus Professor, MD, PhD (0039 0239042801, pierachille.santus@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in transcriptomics of pro-inflammatory and anti-inflammatory cytokines in COPD patients exposed to erdosteine. (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.