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Study of Two Doses of EXPD-101 vs Placebo for Reducing COPD Exacerbations in Adults with Chronic Obstructive Pulmonary Disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

A study is being conducted in people who have Chronic Obstructive Pulmonary Disease (COPD), a lung condition that makes breathing difficult and can cause sudden worsening of symptoms called exacerbations. The trial is testing a new oral tablet called EXPD-101, which is taken once daily, and comparing it to a placebo, which looks the same but contains no active medicine. The main goal of the research is to see whether EXPD-101 can reduce the number of moderate and severe COPD exacerbations over the course of a year while also being safe and well‑tolerated.

Participants will be randomly assigned to one of two groups: one receiving the study drug and the other receiving the placebo. The study is double‑blind, meaning neither the participants nor the study staff know which treatment is being given, and both groups are followed at the same time (parallel arm). Over roughly 52 weeks, participants will take the tablet each day and attend regular clinic visits where simple tests such as breathing measurements (including forced expiratory volume in 1 second and forced vital capacity) and questionnaires about respiratory symptoms will be completed. Blood samples may be taken to understand how the drug is absorbed and cleared from the body (pharmacokinetics), and safety will be monitored through checks of vital signs, heart rhythm recordings, and routine lab tests.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Randomization and start of medication
After joining the study you will be assigned to receive either expd-101 or a matching placebo. the assignment is random and neither you nor the study staff will know which one you receive.
The study medication is provided as an oral tablet. the prescribed dose is 40 mg taken by mouth once each day.
Step 2
Daily medication intake
You will take one tablet each day for a total period of 52 weeks. the tablet should be swallowed with water and taken at roughly the same time each day.
If you are assigned to the placebo group, the tablet will look the same but does not contain the active substance.
Step 3
Regular safety and health assessments
Throughout the 52‑week period you will attend scheduled clinic visits. during each visit the study staff will check your vital signs (such as blood pressure and heart rate), perform an electrocardiogram (ecg) to record the heart’s electrical activity, conduct a physical exam, and collect blood or urine samples for laboratory evaluation.
These assessments help monitor any side effects or changes in your health while you are taking the study medication.
Step 4
Questionnaires and lung function tests
At designated visits you will complete the st. george's respiratory questionnaire (sgrq) to report how your breathing affects daily life, and the evaluating respiratory symptoms (e‑rs) questionnaire to record symptom severity.
You will also undergo lung function testing, which measures the amount of air you can force out in one second (fev1) and the total amount of air your lungs can hold (fvc). these tests are performed after using a bronchodilator medication to open the airways.
Step 5
Final visit and end of treatment
At the end of the 52‑week treatment period you will have a final clinic visit. the same safety checks, laboratory tests, questionnaires, and lung function measurements will be repeated.
The data collected during this final visit will be used to assess the overall effect of expd-101 compared with the placebo on exacerbations of chronic obstructive pulmonary disease and on safety.

Who can join the trial?

14 criteria

Must be able and willing to sign a written informed consent form and follow all study rules.
If you could become pregnant, you must use a highly effective birth control method (less than 1% chance of failure each year) and you cannot donate eggs during the study or for 14 days after the last dose.
Male participants must do one of the following for the whole study and for 14 days after the last dose:
- abstain from heterosexual intercourse,
- use a condom with any female partner who also uses a highly effective birth control method,
- have had a vasectomy at least 3 months before screening, or
- not donate sperm.
- Your body mass index (BMI) must be 18.5 or higher but less than 35 kg/m², and you must weigh at least 50 kg if male or 45 kg if female.
- You must have been diagnosed with chronic obstructive pulmonary disease (COPD) for at least one year according to GOLD guidelines, or have medical records showing COPD for at least 12 months.
- You need a doctor‑confirmed diagnosis of chronic bronchitis (a cough that produces mucus most days for at least three months in the past year).
- You must have had at least two moderate or more than one severe COPD flare‑ups (exacerbations) in the 12 months before screening.
- You must be a current or former tobacco smoker with a history of at least 10 pack‑years (for example, smoking one pack a day for ten years). People who have never smoked are not eligible.
- You must be on a stable inhaled medication plan (either dual therapy such as LABA/LAMA, ICS/LAMA, or ICS/LABA, or triple therapy with all three) for at least three months before joining the study.
- Your lung test after using a bronchodilator must show an FEV1/FVC ratio less than 0.7 and an FEV1 that is at least 40% of the predicted normal value.
- Your COPD Assessment Test (CAT) score must be 10 or higher at screening.

Who cannot join the trial?

21 criteria

Had a worsening of COPD symptoms (exacerbation) in the 4 weeks before the study started.
Any major abnormal results in physical exam, vital signs, blood tests, chemistry tests, or urine tests that the doctor thinks could put you at risk or affect study results.
Known allergy or reaction to any part of the study medication.
Currently taking biologic drugs for COPD (such as dupilumab or mepolizumab) or have taken biologic drugs within the last 5 half‑lives or 4 months (whichever is longer).
Using long‑term oxygen therapy for more than 12 hours each day.
Started a new regular COPD treatment within the past 3 months.
Receiving allergy shots (immunotherapy) unless you have been stable for at least 1 month and are not in the beginning (induction) phase.
Received immunoglobulin (antibody) products or blood products in the 30 days before screening.
Got a live attenuated vaccine (a weakened‑virus vaccine) within 30 days before screening.
Are in the early (acute) phase of a lung‑exercise program that started less than 4 weeks before screening (maintenance phase is allowed).
Have a tooth that could cause pain or infection unless it is fixed before the study starts.
Have another serious lung disease besides COPD, such as asthma, active lung infection, significant bronchiectasis (damage to airway walls), pulmonary fibrosis (scarring of lung tissue), cystic fibrosis, lung cancer, alpha‑1 antitrypsin deficiency, or tuberculosis.
Have active gum disease (periodontal disease) and are currently being treated for it or will need gum‑related procedures during the study.
Plan to have a tooth pulled out during the study period.
Have a weakened immune system (immunodeficiency) or test positive for hepatitis B, hepatitis C, or HIV (human immunodeficiency virus).
Had pneumonia that required antibiotics or antiviral medicine within 28 days before the first visit.
Had a serious infection (other than pneumonia) or an acute upper or lower respiratory infection that needed antibiotics or antiviral medicine within 14 days before the first visit.
Show signs of active liver disease (with or without ongoing treatment).
Have a prolonged QT interval on an ECG (heart rhythm test) – specifically a QTcF longer than 450 milliseconds (or longer than 480 milliseconds if you have a bundle branch block, a type of heart conduction problem).
Have current or recent (within the past year) problems with substance or alcohol abuse.
Have a history of cancer, except for certain skin cancers (basal cell carcinoma, localized squamous cell carcinoma) or in‑situ cervical cancer if treatment was finished at least 12 months ago, or other cancers if treatment was finished at least 5 years ago.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

ASST Fatebenefratelli Sacco
Verified
Milan, Italy
Semmelweis University
Responsive
Budapest, Hungary
Spitalul Clinic Judetean De Urgenta Cluj
Responsive
Cluj Napoca, Romania

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Investigated drugs

EXPD-101 is an oral tablet being studied as a new treatment for chronic obstructive pulmonary disease (COPD). In this trial, participants take the tablet each day for up to one year. The medication is being tested to see if it can reduce the number of moderate and severe flare‑ups of COPD compared with no active treatment. Researchers also monitor how well participants tolerate the tablet and whether it is safe to use over a long period. The study looks at how the drug works in the body and whether it can improve overall health and quality of life for people with COPD.

What is already known about the treatment

EXPD-101 - EXPD-101 is taken as a 40 mg tablet by mouth. It is still an experimental medicine being evaluated in clinical trials and is not yet approved for routine use. The drug is being studied for the treatment of chronic obstructive pulmonary disease (COPD) to lower the number of moderate and severe flare‑ups. It works by blocking a specific molecular target that reduces airway inflammation, placing it in the class of receptor‑blocking anti‑inflammatory agents.

Investigated diseases

Chronic obstructive pulmonary disease (COPD) exacerbations - Chronic obstructive pulmonary disease is a long‑term lung condition that causes airflow limitation and symptoms such as breathlessness, cough and sputum production. Exacerbations are episodes when these symptoms suddenly become much worse than the usual day‑to‑day variation. They are often triggered by infections or environmental irritants and lead to increased shortness of breath, more sputum and reduced ability to perform daily activities. An exacerbation may last from several days to weeks and often requires additional medical attention. Frequent exacerbations can accelerate the overall decline in lung function over time.