A phase I study investigating the local tolerability and pharmacokinetics of isoniazid (INH) inhalation by wet nebulization in patients with tuberculosis
Tuberculosis (TB) is a serious bacterial infection that mostly affects the lungs. The standard treatment involves taking several antibiotic tablets for months, including a drug called isoniazid. While tablets work well, they can cause side effects across the whole body. This early clinical trial (Phase I) is testing whether isoniazid can be given directly to the lungs using a wet nebuliser. A nebuliser turns liquid medicine into a gentle mist that you inhale. Delivering the medicine straight to where the infection lives could help it work better with fewer body-wide side effects. Because this is one of the first times this inhaled form is being tested in people with TB, the main goal is safety. Researchers want to check how well the lungs tolerate the mist and measure how much medicine enters the blood.
At a glance
What is this study about?
Tuberculosis, often called TB, is an infection caused by bacteria that usually targets the lungs. For decades, doctors have treated TB with a combination of daily antibiotic tablets. One of the most important of these medicines is called isoniazid. Taking tablets by mouth works, but the medicine travels through the entire body before reaching the lungs. This can sometimes cause unwanted side effects, such as upset stomachs or liver stress.
Researchers are now exploring a different approach: breathing the medicine directly into the airways. In this study, isoniazid is turned into a liquid mist using a device called a nebuliser. By inhaling the drug straight into the lungs, doctors hope to deliver high levels of medicine directly to the infection while keeping levels in the rest of the body low. This could potentially make treatment more effective and cause fewer side effects.
This research is a Phase I trial. This means it is an early step in testing the treatment in humans. The main purpose is not yet to prove how well it cures the disease, but rather to check that breathing in the medicine is safe and does not cause severe coughing, wheezing, or lung irritation. The team will also measure how the body absorbs and breaks down the inhaled drug.
If successful, this study could pave the way for newer, more targeted treatments for TB in the future. Better treatment options could make completing therapy easier for patients worldwide.
Key takeaways
- Testing a new way to deliver the TB medicine isoniazid directly into the lungs.
- Uses a wet nebuliser so the medicine can be inhaled as a fine mist.
- Phase I study focused on safety, lung comfort, and how the body absorbs the drug.
- Open to adults aged 18 and older diagnosed with tuberculosis.
- Participation is entirely voluntary and will not affect your standard healthcare.
Who may be eligible?
This trial is open to adults aged 18 and over who have been diagnosed with tuberculosis. Because this is an early safety study, the research team needs to look carefully at each person's general health to make sure joining the trial is safe for them.
Both men and women may be able to join. You will need to be well enough to breathe through a nebuliser comfortably and attend the clinic for regular health checks and tests.
People with certain other lung conditions, severe allergies, or other significant medical issues might not be able to take part. The study doctors will discuss your full medical history with you before deciding if the trial is a good fit.
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 tuberculosis (TB).
- I am able to use a nebuliser to breathe in medicine.
- I can attend scheduled clinic visits and blood tests.
- I am willing to discuss my full medical history with the research team.
What does participation involve?
Taking part in this study involves attending a specialist clinic or hospital unit. During your visits, you will breathe in the liquid isoniazid through a nebuliser mouthpiece or mask for a set amount of time. You will be closely monitored by doctors and nurses throughout the process to ensure you feel comfortable. The team will perform regular checks, such as measuring your blood pressure, listening to your chest, and doing simple breathing tests to see how your lungs are responding. You will also have small blood samples taken at set times to see how much medicine reaches your bloodstream. The trial team will explain exactly how many visits you need and how long each visit will take before you agree to join.
Potential risks and benefits
Locations (1)
- —UnverifiedNetherlands
Common questions
What is a nebuliser?
A nebuliser is a small, quiet machine that turns liquid medicine into a fine, cool mist, allowing you to breathe it deep into your lungs through a mask or mouthpiece.
Does this replace my standard TB treatment?
No. This trial is testing how safe inhaled isoniazid is. Your study doctor will ensure you continue to receive the full standard care needed to treat your TB safely.
What does a Phase I trial mean?
A Phase I trial is an early-stage study in humans. It focuses primarily on safety, finding out how comfortable a treatment is and how the body handles the medicine.
Will taking part cure my TB faster?
There is no guarantee that taking part will speed up your recovery. The main goal right now is checking safety rather than measuring cure rates.
Can I leave the study if I change my mind?
Yes. You can leave the study at any point without giving a reason, and your regular NHS 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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