CompletedPhase IInterventional

A study to develop a computer model for measuring how a drug is distributed in the lungs

Inhalers are vital for treating chest conditions such as asthma and chronic obstructive pulmonary disease (COPD). However, getting medicine directly to where it is needed in the lungs can be difficult. This trial aims to track exactly where inhaled medicines land inside the airways. Researchers will study 15 adults: five healthy volunteers, five with asthma, and five with COPD. Participants will test three standard, approved inhalers. Special scans will track the spray using tiny, safe amounts of a radioactive tracer. The main goal is not to test a new drug, but to collect precise data to build an advanced computer model. In the future, drug developers could use this virtual model to test new inhaler designs quickly and safely, without needing to run as many clinical trials on human volunteers. The study takes place across clinic sites in Belgium and the UK.

At a glance

Status

Completed

Phase

Phase I

Sponsor

Fluidda (Belgium)

Enrolment target

Start

30 Jun 2026

Estimated completion

14 Sep 2026

Chronic obstructive pulmonary disease (COPD), asthma

What is this study about?

Millions of people rely on inhalers every day to manage breathing conditions like asthma and COPD. An inhaler works best when its medicine reaches deep into the smallest airways of the lungs. At present, developing and testing new inhalers takes many years and requires large numbers of volunteers to take part in clinical trials.

To help speed up this process and make it safer, researchers want to build a realistic computer simulation of the human lungs. This digital tool will show how different sprays move through healthy lungs compared to lungs narrowed by asthma or COPD. To make the computer model as accurate as possible, scientists need real-world pictures showing where inhaled medicines actually settle.

During this study, participants will use three widely used inhalers. A tiny, safe amount of a radioactive tracer is added to each inhaler so that a specialised camera can photograph the spray inside the chest. This technique, called gamma scintigraphy, allows scientists to see the exact pattern of the medicine in the airways.

Once completed, this computer model will allow engineers and doctors to test new inhaler technologies on a computer screen first. This should reduce the cost of developing lung medicines and mean fewer human volunteers need to be exposed to experimental procedures in early-stage trials.

Key takeaways

Small Phase I trial involving 15 adults: five healthy volunteers, five with asthma, and five with COPD.
Uses three standard, widely prescribed inhalers labelled with a tiny amount of a radioactive tracer.
Helps build a computer simulation so future inhalers can be tested virtually rather than on humans.
Requires screening and CT scans in Belgium, followed by a four-day stay at a clinical unit in the UK.
Offers no personal medical benefit, but helps improve future treatments for lung conditions.

Who may be eligible?

This study is open to adults aged between 21 and 75 who are recruited and screened in Belgium. The researchers are looking for three specific groups of people: healthy volunteers with no ongoing lung problems, people diagnosed with asthma, and people living with chronic obstructive pulmonary disease (COPD).

To be eligible, your weight must be 120 kg or less, and your body mass index (BMI) must fall between 18 and 30. You also need to be able to understand and follow spoken instructions, as the study involves performing specific breathing techniques during lung function tests and imaging sessions.

Because the study uses imaging scans that involve radiation, women who are pregnant or breastfeeding cannot take part. Female participants must have a negative pregnancy test before starting. Both men and women who could potentially have children must agree to use reliable forms of contraception before, during, and for a short time after the study.

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.

You are aged between 21 and 75 years.
You live in or can easily travel to Belgium for initial screening and scans.
You are either a healthy volunteer or have a diagnosis of asthma or COPD.
Your weight is 120 kg or less, with a BMI between 18 and 30.
You are not pregnant or breastfeeding, and agree to use effective contraception if needed.
You are able to carry out breathing exercises and lie still for scans.

Answer every question to see your result.

What does participation involve?

Taking part involves several stages across Belgium and the UK. First, you will attend a screening visit and have chest CT scans at a clinic in Belgium to check if you are suitable. Next, you will travel to a specialist clinic in South Wales, UK, for an imaging stay lasting about four days. During this stay, you will use three common, approved inhalers (Atrovent, Flixotide, and Bevespi) on separate days. After each dose, a special scanner will take pictures of your chest. You will also have routine health checks, including blood pressure monitoring, heart traces (ECGs), and breathing tests. Finally, seven days after your UK visit, a doctor will call you at home for a quick follow-up chat to see how you are feeling. The entire study lasts a few weeks from your first check to the final phone call.

Potential risks and benefits

Taking part will not improve your health directly, but your participation could help scientists design better inhalers for future patients. The study involves standard checks, such as blood pressure cuffs and sticky heart pads, which may cause brief discomfort or skin redness. Breathing tests can sometimes bring on a cough, mild shortness of breath, or lightheadedness, and one test involves sitting briefly in a small clear booth that may feel uncomfortable if you dislike enclosed spaces. You will also receive a low dose of radiation from the scans—roughly equal to the natural radiation an average person absorbs from their normal environment in a year. Doctors consider the added cancer risk from this dose to be extremely small. As with all clinical research, taking part is your choice, and you can withdraw at any time without your regular medical care being affected.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Simbec Research Limited
City only
Merthyr Tydfil, Wales
Medimprove BV
City only
Kontich, Belgium
Medimprove BV
City only
Mortsel, Belgium

Common questions

Will I be given an experimental medicine?

No. All three inhalers used in this study (Atrovent, Flixotide, and Bevespi) are standard, approved medicines that doctors already prescribe every day for breathing conditions.

Is the radiation from the scans safe?

The scans expose you to a total of about 4.57 millisieverts of radiation. This is a low dose, roughly equal to the natural background radiation you would absorb over one year living in Belgium, and the health risk is considered minimal.

Do I have to travel to both Belgium and the UK?

Yes. The initial health checks, CT scans, and final follow-up call are run by a clinic in Belgium, while the four-day imaging stay takes place at a specialised research unit in the UK.

What happens if I feel uncomfortable during the breathing tests?

You can tell the medical team at any time. If you feel dizzy, breathless, or claustrophobic during any test, the team can pause or stop the procedure immediately.

Can I leave the study early if I change my mind?

Yes. Joining the trial is entirely voluntary. You are free to stop taking part at any stage without giving an explanation, and it will not affect your normal healthcare.

How to find out more

Hosein Sadafi

hosein.sadafi@fluidda.com +61 (0)48201 8622 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.