Chronic Obstructive Pulmonary DiseasePhase 2NCT05572333
Clinical Trial to Investigate the Safety and Tolerability of EP395 in Patients With COPD
A Phase 2 study testing EP395 in people with Chronic Obstructive Pulmonary Disease and COPD, run by EpiEndo Pharmaceuticals at 6 sites in 2 countries.
Trial summary
The aim of this clinical trial is to investigate the safety and tolerability of oral, once-daily EP395 administration in COPD patients for 12 weeks. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, COPD
- What is being tested?
- EP395
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 22 Nov 2022to 24 Nov 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Willing and able to understand the information on the nature, the scope, and the relevance of the study, and to provide voluntary, written informed consent to participate in the study before any study-related procedures
- Men and women, aged ≥45 years
- Women of childbearing potential must:
- have a negative pregnancy test (blood) at Screening and (urine) Day 1
- agree to use, and be able to comply with, highly effective measures of contraceptive control (failure rate less than 1% per year when used consistently and correctly) without interruption, during study participation and until 90 days after the last investigational product (IP) intake.
- agree to abstain from breast feeding during the study participation and for 90 days after the last IP intake.
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- Men must agree to use a condom during sexual intercourse with women of childbearing potential during treatment and for 90 days after the last IP intake and should not donate sperm during this time
- Diagnosed with COPD for at least 2 years with FEV1/forced vital capacity (FVC) ratio <0.70 and FEV1 <70% (post bronchodilator) at Screening
- Receiving at least one maintenance inhaled therapy (ie, long acting beta-agonist [LABA], long acting muscarinic antagonist [LAMA], LABA/LAMA, LABA/inhaled corticosteroid [ICS], LAMA/ICS, or LABA/LAMA/ICS) for at least 3 months before Screening
- Able to tolerate the sputum induction procedure and to produce an adequate (volume and sufficient quality for cell count) sputum sample
- Body mass index of ≥19 and ≤35 kg/m2
- History of sputum production (bronchitic phenotype) for approximately 3 months (minimum, not consecutive) in a year
- Up to date COVID-19 vaccination (according to local law and guidelines)
Who cannot join
- History or presence of any clinically relevant medical condition including laboratory test abnormality or planned surgery that in the investigator's opinion could affect the patient's safety or interfere with the objectives of the study
- Exacerbation of COPD in the 3 months before Screening
- Change in medication for COPD in the 3 months before Screening
- Lung function at Screening that in the investigator's opinion would indicate not safe to perform sputum induction or bronchoscopy (bronchoscopy applicable only in a subset of patients)
- History of or active tuberculosis
- Malignancy within the past 5 years, except removed basal cell carcinoma and resected benign colonic polyps
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- Clinically significant abnormality on 12-lead ECG including prolonged corrected QT interval by Fredericia (QTcF) (>450 msec in men or >470 msec in women; based on triplicate) at Screening and Day 1 pre-dose
- Absolute estimated glomerular filtration rate ([eGFR cystatin C + eGFR creatinine]/2) <60mL/min according to Lund-Malmö equation at Screening
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 x upper limit of normal at Screening
- Use (including prescription, over-the-counter, herbal or dietary) of cytochrome P450 (CYP) inducers within 28 days before first dosing, or strong or moderate inhibitors of CYP3A4 (including dietary eg, grapefruit juice) or P-glycoprotein (Pgp) inhibitors or oral narrow therapeutic index (TI) Pgp substrates (eg, digoxin) within 14 days before first dosing (substrates, inhibitors, and inducers are listed in https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers)
- Use of macrolide, roflumilast, or oral corticosteroid (OCS) within 28 days before Screening
- Ongoing antibiotic treatment at Screening
- Use of home oxygen or home-based non-invasive ventilation 3 months before Screening
- Use of a biological therapy within 3 months before Screening
- Use of herbal remedies within 28 days before first dose until follow-up
- Live vaccine within 28 days or any other vaccine within 14 days before first dose until 28 days after final dose of the IP (with the exception of COVID-19 booster and flu vaccination; see Previous and concomitant medications and therapies)
- Positive hepatitis B surface antigen, hepatitis C antibodies, or human immunodeficiency virus 1 or 2 antibodies at Screening
- Positive test result for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) on Day 1
- Positive drugs of abuse test at Screening, including cotinine only in ex-smokers for at least 3 months
- Use of e-cigarettes and vapes
- History of alcohol or drug misuse within 12 months before Screening
- Pregnant and lactating women
- Prior recovery from recent infection, including but not limited to COVID 19 within the last 30 days before first dosing with IP
- Known hypersensitivity to macrolides or EP395 or any of the excipients (dicalcium phosphate, croscarmellose sodium, magnesium stearate, microcrystalline cellulose)
- Participation in a study of an experimental drug within 5 half-lives or 3 months before Screening, whichever is longer
- Dependent subjects of the sponsor or investigator (eg, employees, relatives)
- Patients without the capacity to understand the nature and risks of the study
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Germany3 sites
IKF Pneumologie GmbH & Co. KG
Frankfurt, 60596
Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
Großhansdorf, 22927
IKF Pneumologie GmbH & Co. KG Institut für klinische Forschung Pneumologie
Mainz, 55128
United Kingdom3 sites
Bradford Royal Infirmary, Clinical Research Facility
Bradford, BD9 6RJ
Medicines Evaluation Unit Ltd. (MEU)
Manchester, M23 9QZ
Southampton University Faculty of Medicine
Southampton, SO16 6YD
About this study
Official title: A Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety and Tolerability of EP395 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
The aim of this clinical trial is to investigate the safety and tolerability of oral, once-daily EP395 administration in COPD patients for 12 weeks.
Read the detailed description
This is a randomised, double-blind, placebo-controlled, multicentre study to assess the safety and tolerability of EP395 in COPD patients.
In this study, EP395 will be administered to COPD patients for the first time. Patients will receive either EP395 or placebo as oral capsules once-daily for 12 weeks. Safety and tolerability will be assessed, as well as effect on lung function, lung inflammation and systemic inflammation. Patients' symptoms and quality of life will be assessed with questionnaires. In a sub-set of patients, bronchoscopies will be conducted, to investigate exploratory biomarkers in bronchial brushings and bronchoalveolar lavage.
- Conditions
- Chronic Obstructive Pulmonary Disease, COPD
- Being tested
- EP395, Placebo
- 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.
EP395Drug
Capsule for oral use
PlaceboDrug
Capsule for oral use
| Study group | Role | What they receive |
|---|---|---|
| EP395 | Experimental | EP395 in repeated doses. Oral, once-daily administration of 3 EP395 capsules for 12 weeks. Receives: Drug: EP395 |
| Placebo | Placebo comparator | Matched placebo capsule. Oral, once-daily administration of 3 placebo capsules for 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of adverse event (AE) occurrence
Measured: From Screening (Day -28 to Day -1) to Day 100
Vital signs: Systolic and diastolic blood pressure
Absolute values and changes from baseline will be summarized for all assessed time points
Measured: Screening (Day -28 to Day -1), Day 1, Day 14, Day 28, Day 42, Day 56, Day 70, Day 84, Day 100
Vital signs: Pulse
Absolute values and changes from baseline will be summarized for all assessed time points
Measured: Screening (Day -28 to Day -1), Day 1, Day 14, Day 28, Day 42, Day 56, Day 70, Day 84, Day 100
Vital signs: Body temperature
Absolute values and changes from baseline will be summarized for all assessed time points
Measured: Screening (Day -28 to Day -1), Day 1, Day 14, Day 28, Day 42, Day 56, Day 70, Day 84, Day 100
Vital signs: Respiratory rate
Absolute values and changes from baseline will be summarized for all assessed time points
Measured: Screening (Day -28 to Day -1), Day 1, Day 14, Day 28, Day 42, Day 56, Day 70, Day 84, Day 100
Assessment of laboratory values (haematology)
Mean corpuscular haemoglobin, mean corpuscular haemoglobin concentration, mean corpuscular volume, haematocrit, haemoglobin, platelet count, white blood cell count with differentials (neutrophils, lymphocytes, monocytes, eosinophils, basophils).
Absolute values and changes from baseline will be summarized for all assessed time points.
Measured: Screening (Day -28 to Day -1), Day 1, Day 14, Day 28, Day 42, Day 56, Day 70, Day 84, Day 100
Assessment of blood coagulation
International normalized ratio, prothrombin time (quick test), and activated partial thromboplastin time will be assessed.
Absolute values and changes from baseline will be summarized for all assessed time points.
Measured: Screening (Day -28 to Day -1), Day 1, Day 14, Day 28, Day 42, Day 56, Day 70, Day 84, Day 100
Assessment of laboratory values (biochemistry)
Liver function parameters and fasting lipids (at Screening and Day 84) will be assessed in addition to the following other parameters: bicarbonate, calcium, creatinine, creatine phosphokinase, cystatin C (screening only), fasting glucose (at Screening only), sodium, urea, estimated glomerular filtration rate (at Screening only)
Absolute values and changes from baseline will be summarized for all assessed time points
Measured: Screening (Day -28 to Day -1), Day 1, Day 14, Day 28, Day 42, Day 56, Day 70, Day 84, Day 100
Urinalysis
pH, glucose, protein, blood (hemoglobin), leukocytes, ketones and nitrite will be assessed.
Clinical abnormalities will be evaluated
Measured: Screening (Day -28 to Day -1), Day 1, Day 28, Day 56, Day 84, Day 100
ECG heart rate
Absolute values and changes from baseline will be summarized for all assessed time points
Measured: Screening (Day -28 to Day -1), Day 1, Day 14, Day 28, Day 56, Day 84, Day 100
ECG RR interval
Absolute values and changes from baseline will be summarized for all assessed time points
Measured: Screening (Day -28 to Day -1), Day 1, Day 14, Day 28, Day 56, Day 84, Day 100
ECG PR interval
Absolute values and changes from baseline will be summarized for all assessed time points
Measured: Screening (Day -28 to Day -1), Day 1, Day 14, Day 28, Day 56, Day 84, Day 100
ECG QRS duration
Absolute values and changes from baseline will be summarized for all assessed time points
Measured: Screening (Day -28 to Day -1), Day 1, Day 14, Day 28, Day 56, Day 84, Day 100
ECG QT interval (uncorrected)
Absolute values and changes from baseline will be summarized for all assessed time points
Measured: Screening (Day -28 to Day -1), Day 1, Day 14, Day 28, Day 56, Day 84, Day 100
ECG QTcF intervals
Absolute values and changes from baseline will be summarized for all assessed time points
Measured: Screening (Day -28 to Day -1), Day 1, Day 14, Day 28, Day 56, Day 84, Day 100
Standard routine physical examination
A standard routine physical body examination will be performed and abnormal physical examination results will be evaluated. Clinically significant abnormalities will be reported as AEs.
Measured: Screening (Day -28 to Day -1), Day 1, Day 28, Day 56, Day 84, Day 100
Secondary outcomes (6)
Sputum cells (total and differential) and inflammatory mediators
Assessment of inflammatory mediators will include mediators including interleukin (IL) 8, tumour necrosis factor (TNF)-α, IL-6, IL 1β, macrophage inflammatory protein (MIP) 1α, MIP-1β, monocyte chemotactic protein (MCP)-1, surfactant protein D (SP-D), granulocyte macrophage colony-stimulating factor (GM-CSF), IL-23, IL-33, IL-25, IL-10, neutrophil elastase (NE), matrix metalloproteinase (MMP)-9, CXC motif chemokine ligand (CXCL)1, myeloperoxidase (MPO)
Measured: Screening (Day -28 to Day -1), Day 1, Day 42, Day 70, Day 84
Blood inflammatory markers
Including assessment of fibrinogen (FBG), C-reactive protein (CRP), TNF-α, IL-6 and α2 macroglobulin
Measured: Day 1, Day 42, Day 84
Forced expiratory volume in 1 second (FEV1)
Measured: Screening (Day -28 to Day -1), Day 1, Day 28, Day 56, Day 84
Plasma levels of EP395
Measured: Day 14, Day 28, Day 42, Day 56, Day 70, Day 80, Day 84
St George's respiratory questionnaire (SGRQ)
Measured: Screening (Day -28 to Day -1), Day 1, Day 28, Day 56, Day 84
Exacerbations of COPD tool (EXACT) respiratory symptoms (E-RS)
Measured: Screening (Day -28 to Day -1), daily from Day 1 to Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start22 Nov 2022
- Primary completion24 Nov 2023
- Study completion24 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is double-blind, placebo-controlled and parallel-group in design.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- EpiEndo Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- FGK Clinical Research GmbH
- Responsible party
- Sponsor
- Investigators
- Sukh Dave Singh, Prof., Principal investigator, Medicines Evaluation Unit Ltd. (MEU), Manchester, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05572333
- Sponsor's protocol ID
- EP395-003
- Status last verified
- Jun 2026
- First submitted
- 30 Sep 2022
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Watz H, Korn S, Kornmann O, Singh D, Wilkinson T, Hanrott K, Staples KJ, Ackland J, Norris V. A randomised controlled trial of EP395, a novel anti-inflammatory macrolide, in stable COPD patients. ERJ Open Res. 2026 May 26;12(3):00782-2025. doi: 10.1183/23120541.00782-2025. eCollection 2026 May.
PubMed 42206016
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety and Tolerability of EP395 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT05572333
- Acronym / sponsor ID
- EP395-003
- Conditions
- Chronic Obstructive Pulmonary Disease, COPD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- EpiEndo PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- FGK Clinical Research GmbH
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- 24 Nov 2023 (actual)
- Study completion
- 24 Nov 2023 (actual)
- First posted
- 7 Oct 2022 (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.
The aim of this clinical trial is to investigate the safety and tolerability of oral, once-daily EP395 administration in COPD patients for 12 weeks.
Detailed description
This is a randomised, double-blind, placebo-controlled, multicentre study to assess the safety and tolerability of EP395 in COPD patients.
In this study, EP395 will be administered to COPD patients for the first time. Patients will receive either EP395 or placebo as oral capsules once-daily for 12 weeks. Safety and tolerability will be assessed, as well as effect on lung function, lung inflammation and systemic inflammation. Patients' symptoms and quality of life will be assessed with questionnaires. In a sub-set of patients, bronchoscopies will be conducted, to investigate exploratory biomarkers in bronchial brushings and bronchoalveolar lavage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The study is double-blind, placebo-controlled and parallel-group in design.
| Arm | Type | Receives |
|---|---|---|
| EP395 | Experimental | Drug: EP395EP395 in repeated doses. Oral, once-daily administration of 3 EP395 capsules for 12 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboMatched placebo capsule. Oral, once-daily administration of 3 placebo capsules for 12 weeks. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Willing and able to understand the information on the nature, the scope, and the relevance of the study, and to provide voluntary, written informed consent to participate in the study before any study-related procedures
- Men and women, aged ≥45 years
- Women of childbearing potential must:
- Men must agree to use a condom during sexual intercourse with women of childbearing potential during treatment and for 90 days after the last IP intake and should not donate sperm during this time
- Diagnosed with COPD for at least 2 years with FEV1/forced vital capacity (FVC) ratio <0.70 and FEV1 <70% (post bronchodilator) at Screening
Key exclusion criteria (27 listed)
- History or presence of any clinically relevant medical condition including laboratory test abnormality or planned surgery that in the investigator's opinion could affect the patient's safety or interfere with the objectives of the study
- Exacerbation of COPD in the 3 months before Screening
- Change in medication for COPD in the 3 months before Screening
- Lung function at Screening that in the investigator's opinion would indicate not safe to perform sputum induction or bronchoscopy (bronchoscopy applicable only in a subset of patients)
- History of or active tuberculosis
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 |
|---|---|---|
| EP395Capsule for oral use | Drug | EP395 |
| PlaceboCapsule for oral use | Drug | Placebo |
Primary outcome
Assessment of adverse event (AE) occurrence
Time frame: From Screening (Day -28 to Day -1) to Day 100
Vital signs: Systolic and diastolic blood pressure
Time frame: Screening (Day -28 to Day -1), Day 1, Day 14, Day 28, Day 42, Day 56, Day 70, Day 84, Day 100
Absolute values and changes from baseline will be summarized for all assessed time points
Vital signs: Pulse
Time frame: Screening (Day -28 to Day -1), Day 1, Day 14, Day 28, Day 42, Day 56, Day 70, Day 84, Day 100
Absolute values and changes from baseline will be summarized for all assessed time points
Vital signs: Body temperature
Time frame: Screening (Day -28 to Day -1), Day 1, Day 14, Day 28, Day 42, Day 56, Day 70, Day 84, Day 100
Absolute values and changes from baseline will be summarized for all assessed time points
Vital signs: Respiratory rate
Time frame: Screening (Day -28 to Day -1), Day 1, Day 14, Day 28, Day 42, Day 56, Day 70, Day 84, Day 100
Absolute values and changes from baseline will be summarized for all assessed time points
Assessment of laboratory values (haematology)
Time frame: Screening (Day -28 to Day -1), Day 1, Day 14, Day 28, Day 42, Day 56, Day 70, Day 84, Day 100
Mean corpuscular haemoglobin, mean corpuscular haemoglobin concentration, mean corpuscular volume, haematocrit, haemoglobin, platelet count, white blood cell count with differentials (neutrophils, lymphocytes, monocytes, eosinophils, basophils). Absolute values and changes from baseline will be summarized for all assessed time points.
Assessment of blood coagulation
Time frame: Screening (Day -28 to Day -1), Day 1, Day 14, Day 28, Day 42, Day 56, Day 70, Day 84, Day 100
International normalized ratio, prothrombin time (quick test), and activated partial thromboplastin time will be assessed. Absolute values and changes from baseline will be summarized for all assessed time points.
Assessment of laboratory values (biochemistry)
Time frame: Screening (Day -28 to Day -1), Day 1, Day 14, Day 28, Day 42, Day 56, Day 70, Day 84, Day 100
Liver function parameters and fasting lipids (at Screening and Day 84) will be assessed in addition to the following other parameters: bicarbonate, calcium, creatinine, creatine phosphokinase, cystatin C (screening only), fasting glucose (at Screening only), sodium, urea, estimated glomerular filtration rate (at Screening only) Absolute values and changes from baseline will be summarized for all assessed time points
Urinalysis
Time frame: Screening (Day -28 to Day -1), Day 1, Day 28, Day 56, Day 84, Day 100
pH, glucose, protein, blood (hemoglobin), leukocytes, ketones and nitrite will be assessed. Clinical abnormalities will be evaluated
ECG heart rate
Time frame: Screening (Day -28 to Day -1), Day 1, Day 14, Day 28, Day 56, Day 84, Day 100
Absolute values and changes from baseline will be summarized for all assessed time points
ECG RR interval
Time frame: Screening (Day -28 to Day -1), Day 1, Day 14, Day 28, Day 56, Day 84, Day 100
Absolute values and changes from baseline will be summarized for all assessed time points
ECG PR interval
Time frame: Screening (Day -28 to Day -1), Day 1, Day 14, Day 28, Day 56, Day 84, Day 100
Absolute values and changes from baseline will be summarized for all assessed time points
ECG QRS duration
Time frame: Screening (Day -28 to Day -1), Day 1, Day 14, Day 28, Day 56, Day 84, Day 100
Absolute values and changes from baseline will be summarized for all assessed time points
ECG QT interval (uncorrected)
Time frame: Screening (Day -28 to Day -1), Day 1, Day 14, Day 28, Day 56, Day 84, Day 100
Absolute values and changes from baseline will be summarized for all assessed time points
ECG QTcF intervals
Time frame: Screening (Day -28 to Day -1), Day 1, Day 14, Day 28, Day 56, Day 84, Day 100
Absolute values and changes from baseline will be summarized for all assessed time points
Standard routine physical examination
Time frame: Screening (Day -28 to Day -1), Day 1, Day 28, Day 56, Day 84, Day 100
A standard routine physical body examination will be performed and abnormal physical examination results will be evaluated. Clinically significant abnormalities will be reported as AEs.
6 secondary outcomes
Sputum cells (total and differential) and inflammatory mediators
Time frame: Screening (Day -28 to Day -1), Day 1, Day 42, Day 70, Day 84
Blood inflammatory markers
Time frame: Day 1, Day 42, Day 84
Forced expiratory volume in 1 second (FEV1)
Time frame: Screening (Day -28 to Day -1), Day 1, Day 28, Day 56, Day 84
Plasma levels of EP395
Time frame: Day 14, Day 28, Day 42, Day 56, Day 70, Day 80, Day 84
St George's respiratory questionnaire (SGRQ)
Time frame: Screening (Day -28 to Day -1), Day 1, Day 28, Day 56, Day 84
Exacerbations of COPD tool (EXACT) respiratory symptoms (E-RS)
Time frame: Screening (Day -28 to Day -1), daily from Day 1 to Day 84
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Results publication: PubMed 42206016Watz H, Korn S, Kornmann O, Singh D, Wilkinson T, Hanrott K, Staples KJ, Ackland J, Norris V. A randomised controlled trial of EP395, a novel anti-inflammatory macrolide, in stable COPD patients. ERJ Open Res. 2026 May 26;12(3):00782-2025. doi: 10.1183/23120541.00782-2025. eCollection 2026 May.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Sukh Dave Singh, Prof. principal investigator
Medicines Evaluation Unit Ltd. (MEU), Manchester, United Kingdom
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EP395 in people with Chronic Obstructive Pulmonary Disease and COPD, run by EpiEndo Pharmaceuticals at 6 sites in 2 countries.
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 13 inclusion and 27 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: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, United Kingdom. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of adverse event (AE) occurrence (time frame: From Screening (Day -28 to Day -1) to Day 100). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05572333, which also lists 1 linked publication.
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 1 Jul 2026.