Ongoing, recruitingTherapeutic use (Phase IV)Interventional

A single-centre, randomized, double blind, placebo controlled, crossover, single dose clinical trial to compare orodispersible presentations of bilastine, ebastine, and desloratadine in the suppression of wheal and flare induced by intradermal histamine in healthy volunteers.

This study aims to find out how quickly certain allergy medicines, which are designed to dissolve quickly in your mouth, start to reduce common allergy symptoms. Healthy adult volunteers will take one of the fast-dissolving medicines (bilastine, ebastine, or desloratadine) or a dummy pill. To test their effectiveness, a small amount of a substance that causes a mild allergic reaction (like a nettle sting) will be applied to the skin, causing a red, swollen bump. Researchers will then measure how well and how fast each medication reduces this redness and swelling compared to the dummy pill. The study will also look at how long the effects last, if there are any side effects, and how much of the medicine gets into the bloodstream. This information helps doctors understand which fast-acting allergy medicine might be best for quick relief.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Faes Farma S.A., A. Menarini Industrie Farmaceutiche Riunite S.r.l.

Enrolment target

Start

10 Apr 2025

Allergy

What is this study about?

This study is designed to understand how quickly different allergy medications start to work when you take them in a special fast-dissolving form. You might have heard of these types of medicines as 'melt-in-the-mouth' tablets. The main goal is to compare three common allergy medicines: bilastine, ebastine, and desloratadine, all given in this quick-acting format.

To do this, healthy volunteers will receive a tiny amount of a substance under their skin that usually causes a small, temporary allergic reaction – a bit like a mosquito bite or a nettle sting. This reaction creates a red, itchy bump (called a 'wheal' and 'flare'). The researchers will then give you one of the allergy medications or a dummy pill (placebo) and measure how quickly the medication reduces the size of this bump, and how much the itching improves. This helps them see which medicine works fastest and how well it tackles allergy symptoms right from the start.

This kind of study is called a 'Phase IV' trial, which means the medicines are already approved and widely used. The purpose here isn't to test if the medicines are safe in general, but to learn more about how they work in specific situations, like how quickly these fast-dissolving versions kick in to provide relief. The findings will help doctors better advise patients on which treatment might be best when they need fast relief from allergy symptoms.

Key takeaways

Tests how fast different 'melt-in-the-mouth' allergy medicines work.
Uses a small skin prick to create a temporary allergic reaction.
Compares three common allergy drugs (bilastine, ebastine, desloratadine) to a dummy pill.
Open to healthy adults aged 18 and over.
Aims to understand which medicine offers the quickest relief from allergy symptoms.
Involves multiple visits and close monitoring of your health.

Who may be eligible?

This study is open to healthy adults, both men and women, who are 18 years old or older. You don't need to have allergies to take part, as the study is looking at how the medications work in healthy people.

Before you can join, the study team will ask you some questions about your health and may do a few tests to make sure it's safe for you to participate and that your results will be helpful for the study. For example, they'll check that you're not pregnant or breastfeeding, and that you don't have any serious ongoing medical conditions.

Detailed criteria would be provided by the study team, but generally, you'll need to be in good overall health and able to commit to the study schedule.

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?
Are you generally in good health?
Are you not pregnant or breastfeeding?
Are you able to attend multiple study visits at a single location?
Do you not have any major ongoing medical conditions?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be attending a single research centre for several visits. During these visits, you'll be given a small prick on your skin to create a mild allergic reaction, followed by one of the study medications (either bilastine, ebastine, desloratadine, or a dummy pill). You won't know which one you're getting. Over several hours, the research team will regularly measure the size of the red bump on your skin and ask about any itching you feel. They will also take blood samples to measure how much of the medicine is in your system. This process will be repeated over different visits, so you get to try each of the active medicines and the dummy pill on separate occasions. You'll also have standard health checks like blood tests, vital signs (blood pressure, heart rate), and an ECG (heart tracing) to monitor your safety. The total duration of your participation will involve multiple visits spread over a period, ensuring enough time passes between treatments.

Potential risks and benefits

Taking part could offer you the benefit of close medical supervision and contribute to important scientific knowledge that helps others with allergies. You won't directly benefit from the medication for an existing allergy as you'll be a healthy volunteer. Potential risks are generally mild and temporary, such as discomfort from the skin prick test, potential side effects from the allergy medications (though these are commonly used and generally well-tolerated), and some discomfort from blood draws. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

—
Unverified
Spain

Common questions

What does 'single-centre' mean?

It means the study is being conducted at just one location, rather than across multiple hospitals or clinics.

What is a 'dummy pill' or 'placebo'?

A dummy pill looks exactly like the real medicine but contains no active ingredients. It helps researchers see the true effect of the medication.

What are 'fast-dissolving' tablets?

These are tablets designed to quickly dissolve in your mouth without needing water, potentially leading to faster absorption into your body.

Will this study cure my allergies?

No, this study is not designed to cure allergies. It's investigating how quickly existing allergy medications work in a specific form.

Do I need to have allergies to join?

No, this study is looking for healthy volunteers, so you don't need to have allergies to take part.