Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Patient reported efficacy of intranasal lysine-aspirin in controlling NSAID-exacerbated respiratory disease.

This study is investigating a new treatment for a specific type of breathing problem called NSAID-Exacerbated Respiratory Disease (N-ERD). People with N-ERD can experience asthma and sinus issues when they take common pain relievers like ibuprofen or naproxen. The researchers are testing a nasal spray containing lysine-aspirin – a form of aspirin – to see if it can help reduce these symptoms. They will measure changes in things like nose and asthma severity, quality of life, and the occurrence of side effects, especially stomach problems. This is an early-stage study (Phase II) to explore how well and how safely this new nasal spray works.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

UZ Leuven

Enrolment target

Start

25 Oct 2024

Nonsteroidal anti-inflammatory drug Exacerbated Respiratory Disease (N-ERD)

What is this study about?

This research study is about a health condition called NSAID-Exacerbated Respiratory Disease, or N-ERD for short. If you have N-ERD, you might experience issues like asthma symptoms (wheezing, shortness of breath) or sinus problems (stuffy nose, runny nose) when you take certain common pain relievers. These pain relievers include medications known as NSAIDs, such as ibuprofen or naproxen. This study aims to find a better way to manage these reactions and improve the daily lives of people affected by N-ERD.

The researchers are testing a new approach: a nasal spray. This spray contains a special form of aspirin called lysine-aspirin. Aspirin is a well-known medication, but in this study, it's being given directly into the nose. The main goal is to see if this nasal spray can effectively reduce symptoms like a blocked nose, sinus pain, and asthma attacks that are triggered by NSAIDs. They also want to understand if it can improve a person's general well-being and quality of life.

During the study, the team will carefully track many different aspects. For example, they'll check how much your nose and asthma symptoms improve, how your breathing changes, and if you experience any side effects, particularly stomach upset like nausea or tummy pain. This is a 'Phase II' study, which means it's an early step in testing a new treatment. It's designed to understand if the treatment works and is safe enough to be studied in larger groups of people in the future.

Key takeaways

This study explores a nasal spray with aspirin to treat breathing difficulties caused by pain medicines.
It targets a condition called NSAID-Exacerbated Respiratory Disease (N-ERD).
Researchers will check for improvements in asthma, sinus symptoms, and overall well-being.
They will also monitor for any side effects, especially stomach problems.
This is an early-stage study to understand how well and safely the treatment works.

Who may be eligible?

To join this study, you need to be an adult, at least 18 years old, and your sex doesn't matter – both men and women can take part. The most important thing is that you have been diagnosed with NSAID-Exacerbated Respiratory Disease, meaning you get breathing or sinus problems when you take specific pain relievers.

Detailed requirements will be explained by the study team, but generally, you'll need to be in a stable condition with your N-ERD and not have other uncontrolled medical conditions that might interfere with the study results or your safety. They will also make sure you haven't recently received certain treatments or participated in other studies.

The medical team will carefully review your health and medical history to make sure this study is right for you and that taking part would be safe.

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.

Are you 18 years old or older?
Have you been diagnosed with NSAID-Exacerbated Respiratory Disease (N-ERD)?
Are your N-ERD symptoms currently stable?
Are you willing and able to attend all study appointments?
Are you able to use a nasal spray as instructed?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the nasal spray (either the active treatment or a dummy spray, as assigned by the study). You would also attend several clinic visits so the doctors can monitor your health and how you react to the treatment. These visits will involve various checks, such as answering questionnaires about your symptoms and quality of life, and having some breathing tests. They will also ask about any side effects you might experience, especially stomach problems like sickness or stomach ache. The total duration of your involvement in the study, including follow-up appointments, will be clearly explained to you by the study team.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might find that the nasal spray helps to improve your N-ERD symptoms, which could lead to better breathing and an improved quality of life. However, since this is a new treatment for N-ERD, there's also a chance it might not work for you, or you could experience side effects, particularly stomach issues like nausea, vomiting, or diarrhoea, or other unforeseen reactions. All potential risks will be carefully explained by the study team. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Belgium

Common questions

What is NSAID-Exacerbated Respiratory Disease (N-ERD)?

It's a condition where common pain relievers like ibuprofen or naproxen can trigger asthma symptoms or sinus problems in some people.

What is lysine-aspirin?

It's a specific form of aspirin that the researchers are testing in a nasal spray to see if it helps with N-ERD symptoms.

Will I get the actual treatment?

Some participants will receive the active lysine-aspirin nasal spray, while others might receive a 'dummy' spray (placebo) to compare the effects. You won't know which one you're getting.

What kind of tests will I have?

You'll have various tests, including answering questions about your symptoms and quality of life, and having breathing tests to see how your condition changes.

Can I leave the study if I want to?

Yes, you are free to leave the study at any point, and it will not affect your routine medical care.