A Phase 2a, Randomized, Double-Blind, Parallel-Group, Placebo Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Fexlamose (AER 01) Inhalation Solution in the Treatment of Adults with Moderate to Severe Chronic Obstructive Pulmonary Disease
Chronic obstructive pulmonary disease (COPD) causes long-term breathing difficulties, often made worse by trapped mucus in the lungs. This Phase 2 clinical trial is testing a new inhaled medicine called Fexlamose (also known as AER 01). Researchers want to find out whether Fexlamose is safe, well-tolerated, and effective for adults with moderate to severe COPD. During the four-week study, participants will breathe in either Fexlamose or a dummy liquid (placebo) through a nebuliser. Doctors will measure changes in lung capacity using standard breathing tests, check blood oxygen levels, and use chest CT scans to see if airway blockages improve. Participants will also complete questionnaires about their day-to-day quality of life. This research aims to discover whether Fexlamose could become a helpful new treatment to ease chest symptoms and improve daily breathing.
At a glance
What is this study about?
Chronic obstructive pulmonary disease (COPD) is a long-term condition that damages the airways and makes breathing difficult. Many people living with COPD struggle with persistent coughs, shortness of breath, and stubborn mucus plugs that block air from flowing freely. While existing treatments can help keep airways open, there remains a real need for therapies that clear trapped mucus and improve lung function.
This clinical trial is evaluating an experimental liquid medicine called Fexlamose (AER 01). It is delivered directly into the lungs as a fine mist using a nebuliser. The aim is to see if Fexlamose can help clear mucus plugs and improve overall airflow better than an inactive dummy liquid (a placebo). Because the trial is double-blind, neither the participants nor the research doctors will know who receives the active medicine and who receives the placebo until the study ends.
Throughout the four-week trial, doctors will track lung function by measuring how much air participants can forcefully breathe out in one second. They will also use low-dose chest CT scans to take detailed pictures of the airways, monitoring whether mucus plugs have reduced. If the results are positive, Fexlamose could move forward to larger trials and potentially become an important new treatment option for people managing COPD.
Key takeaways
- Tests a new inhaled liquid medicine, Fexlamose, for moderate to severe COPD.
- Compares the study drug to an inactive dummy treatment (placebo) over 4 weeks.
- Uses breathing tests and CT scans to see if mucus plugs and airflow improve.
- Open to adults aged 18 and over with a confirmed diagnosis of COPD.
- Taking part is entirely voluntary and does not impact your standard NHS medical care.
Who may be eligible?
This study is open to adults aged 18 and older who have been diagnosed with moderate to severe chronic obstructive pulmonary disease (COPD). Both men and women may be eligible to take part.
To join, participants must be able to perform standard lung breathing tests and attend scheduled clinic appointments. Because the trial specifically looks at whether the medicine improves airway blockages, having a confirmed medical history of COPD that affects your day-to-day breathing is essential.
People with certain other severe lung conditions, unstable health issues, or those who cannot safely undergo CT scans may not be able to join. The study medical team will review your full medical history, current inhalers, and general health before you can take part to make sure the trial is safe for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am aged 18 or older.
- I have been diagnosed with moderate to severe COPD.
- I am able and willing to use a nebuliser machine each day.
- I can attend regular clinic appointments and perform breathing tests.
- I am comfortable having blood tests and chest CT scans.
What does participation involve?
Taking part in the study lasts approximately four to six weeks. You will be randomly assigned by a computer to receive either Fexlamose or a placebo solution. You will inhale the assigned liquid mist through a nebuliser device every day as directed by the clinic staff.
You will need to attend several clinic visits, notably at the start and at the end of the four-week treatment period. During these visits, doctors will measure your breathing using a spirometer (a machine you blow into), check your blood oxygen levels, and perform blood and urine tests to monitor your health. You will also have chest CT scans to look closely at your airways and complete short surveys about your symptoms and quality of life.
Potential risks and benefits
Locations (3)
- —UnverifiedBulgaria
- —UnverifiedPoland
- —UnverifiedSpain
Common questions
What is a placebo and why is it used?
A placebo looks and smells like the study medicine but contains no active ingredients. It allows researchers to see if health improvements are truly caused by Fexlamose rather than other factors.
Will I have to stop taking my normal COPD inhalers?
Most participants can continue taking their usual maintenance medicines, but the study doctor will check all your prescriptions to make sure they do not interfere with the trial.
How do I take the study medicine?
The medicine is a sterile liquid that you inhale as a gentle mist through a nebuliser machine, which will be provided and explained to you.
Are there any costs to participate?
No, the study medicine, nebuliser, and all trial-related tests are provided free of charge, and travel expenses are often reimbursed.
Can I leave the study early if I feel it is not right for me?
Yes, you can leave the study at any point without giving a reason, and your regular medical care will continue as normal.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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