RecruitingNAINTERVENTIONAL

Development of a Novel Non-invasive Inflammometry Following Allergen Challenge in Patients With Mild Allergic Asthma

Researchers are exploring new, gentle ways to measure lung inflammation (swelling) in people with mild asthma triggered by allergies. The aim is to see if these new methods can accurately show what's happening in the lungs after someone breathes in something they're allergic to, like pollen or dust mites. This study hopes to improve how we test new medicines for asthma by using advanced scans and breath tests. Participants will have carefully controlled exposure to their allergen, and researchers will monitor lung changes using various non-invasive techniques. The goal is to develop better tools for understanding and treating allergic asthma without needing more invasive procedures in the future.

At a glance

Status

Recruiting

Phase

Sponsor

Fraunhofer-Institute of Toxicology and Experimental Medicine

Enrolment target

Start

09 Aug 2024

Estimated completion

01 Sep 2026

Mild Allergic Asthma

What is this study about?

This study is all about finding new and gentler ways to understand what happens in the lungs of people with mild allergic asthma. When someone with allergic asthma breathes in something they're allergic to, like pollen or dust mites, their airways can become inflamed or swollen. Usually, checking for this inflammation can involve uncomfortable procedures.

The researchers want to test if new techniques, like special types of MRI scans and analyzing a person's breath, can accurately show this inflammation without needing more invasive tests. They will carefully expose participants to a small amount of their allergen to see the effect, then use these new methods to monitor their lungs. Think of it like trying to find a better, clearer picture of what's happening inside the body without having to go inside.

Ultimately, if these new methods work well, they could be used in future studies to test new asthma medications more effectively. This could lead to quicker development of new treatments that help people with allergic asthma breathe easier and manage their condition better. It's about making future research simpler and more comfortable for patients.

Key takeaways

Study aims to find new, gentler ways to measure lung inflammation in mild allergic asthma.
Participation involves 10 visits over 6-8 weeks, plus screening.
Tests include special MRI scans, breathing tests, blood samples, and two bronchoscopies.
You'll have carefully controlled exposure to your allergen.
Goal is to improve how new asthma medications are tested.
You can withdraw from the study at any time.

Who may be eligible?

To be part of this study, you need to be an adult between 18 and 65 years old. You should have had mild allergic asthma for at least a year that's usually well-controlled just by using your rescue inhaler. Your lungs should generally work well, measured by a breathing test, and you must have a positive allergy skin test to a common allergen like pollen or dust mites.

Women who are pregnant, breastfeeding, or planning to become pregnant cannot join. If you are a woman who could become pregnant, you'll need to use a very reliable form of birth control throughout the study. Your body mass index (BMI) should also be within a healthy range, between 18 and 32.

Most importantly, you must be willing to give your written consent, meaning you understand the study and agree to take part. Researchers will also check to make sure your asthma responds in a specific way to your allergen when you're exposed to it in a controlled setting.

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 between 18 and 65 years old?
Do you have mild allergic asthma that is usually well-controlled with just your rescue inhaler?
Have you had a positive skin prick test for an allergy (like pollen or dust mites)?
Are you able and willing to attend all study visits in Hannover?
If you could become pregnant, are you using highly effective contraception and not pregnant or breastfeeding?
Is your Body Mass Index (BMI) between 18 and 32?

Answer every question to see your result.

What does participation involve?

If you join this study, your involvement will last about 6 to 8 weeks for the main part, plus up to another 8 weeks for initial checks. You'll need to attend 10 visits in total, all at Fraunhofer ITEM in Hannover.

The study involves several tests: you'll have specific breathing tests (called 'methacholine challenge' and 'spirometry'), and your skin will be tested for allergies. You'll also have two controlled exposures to a small amount of the allergen you're allergic to. This will happen in a safe, monitored way.

You will undergo two special MRI scans using special gases to help see your lungs better, and two 'bronchoscopies'. During one of these bronchoscopies, a small amount of allergen will be placed directly into a part of your lung. Other tests include collecting blood (around 190 ml in total, about a teacup full), measuring gases and particles in your breath, and samples from your nose. You will also use a peak flow meter and have your sputum (phlegm) collected. The researchers will explain all these procedures in detail.

Potential risks and benefits

Taking part in this study could offer several benefits, such as contributing to medical knowledge that may lead to better asthma treatments in the future. You'll also receive careful monitoring of your asthma. However, there are potential risks, including discomfort from the various tests like blood sampling, breathing tests, and the two bronchoscopies, which are more invasive procedures. Exposure to your allergen will be carefully controlled but could temporarily trigger asthma symptoms. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Fraunhofer Institute for Toxicology and Experimental Medicine
Verified postcode
Hanover, Germany· Recruiting

Common questions

What is 'mild allergic asthma'?

It's a type of asthma often triggered by allergies, where symptoms are generally mild and easily controlled with a 'rescue' inhaler. Your lungs work quite well most of the time.

What is an 'allergen challenge'?

This is a controlled way to expose you to a small, safe amount of the substance you're allergic to, like pollen or dust mites. It helps researchers see how your lungs react.

What is an MRI with 'hyperpolarized xenon'?

It's a special type of MRI scan that uses safe, breathable gas (xenon) to get very detailed pictures of how air moves in your lungs, helping to spot inflammation.

What is a 'bronchoscopy'?

This is a medical procedure where a thin, flexible tube with a camera is gently passed down your throat into your airways to look inside your lungs. It's done under medication to make you comfortable.

Why collect so many different samples?

By collecting blood, breath, and other samples, researchers can compare the current ways of measuring lung inflammation with the new, less invasive methods they are testing.

How to find out more

Jens Hohlfeld, Prof. Dr.

jens.hohlfeld@item.fraunhofer.de +49 511 5350-8101 Official trial record

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