Ongoing, recruitingPhase II and Phase III (Integrated)Interventional

Phase II-III study to assess efficacy and safety of sublingual immunotherapy in patients suffering from grass pollen allergy

This research is a `phase II-III study` testing a new treatment for moderate to severe hay fever caused by grass pollen. It's called `sublingual immunotherapy` and comes as a spray used under the tongue. Researchers want to find out how well this spray works to reduce common hay fever symptoms like sneezing, runny nose, and itchy eyes, especially during the time when grass pollen is at its highest. They will also check if people need to use less of their usual hay fever medicines. The study is comparing different strengths of the spray against a dummy spray (placebo) to see which, if any, is most effective and safe. The goal is to improve the quality of life for people who suffer badly from grass pollen allergies.

At a glance

Status

Ongoing, recruiting

Phase

Phase II and Phase III (Integrated)

Sponsor

ROXALL Medizin GmbH, ROXALL Medizin GmbH

Enrolment target

Start

22 Sep 2023

Moderate-to-severe allergic rhinitis / rhinoconjunctivitis due to grass pollen for at least two years according to the Allergic Rhinitis and its Impact on Asthma (ARIA) guideline

What is this study about?

This study is an important piece of research looking into a new way to help people who suffer from moderate to severe hay fever caused by grass pollen. If you experience bothersome symptoms like a runny nose, sneezing, itchy eyes, and generally feel unwell because of grass pollen, this study might be relevant to you. The main aim is to test a treatment called `sublingual immunotherapy`, which is given as a spray under the tongue. This type of treatment works by gradually getting your body used to the pollen, which can reduce your allergic reaction over time.

The researchers want to see if this special spray can effectively reduce hay fever symptoms during the grass pollen season. They will be comparing different strengths of the active spray with a 'dummy' spray (known as a `placebo`) that looks and feels the same but doesn't contain the active ingredient. This comparison helps them understand if the improvements seen are truly due to the treatment or other factors.

Ultimately, this study hopes to find a safer and more effective way to manage grass pollen allergy, potentially leading to fewer symptoms and less reliance on other hay fever medications. This could significantly improve the daily lives of many people in the UK who struggle with severe hay fever each year.

Key takeaways

Tests a new sublingual (under the tongue) spray for grass pollen allergy.
Aimed at adults with moderate to severe hay fever symptoms.
Compares different spray strengths to a dummy (`placebo`) spray.
Hopes to reduce allergy symptoms and the need for other medicines.
Participation involves regular clinic visits and symptom tracking.

Who may be eligible?

To join this study, people need to be adults, aged 18 or over. There's no upper age limit, so older adults can also take part. Both men and women are welcome to join.

The study is specifically for those who have suffered from moderate to severe hay fever (allergic rhinitis or rhinoconjunctivitis) caused by grass pollen for at least two years. This means your hay fever symptoms must be quite noticeable and affect your daily life when grass pollen is around.

There will be other specific health checks and requirements to make sure the study is right and safe for each person, but these are the main starting points for who can be considered.

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?
Do you get moderate to severe hay fever from grass pollen?
Have you had grass pollen hay fever for at least two years?
Are your symptoms noticeable and affect your daily life during grass pollen season?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you might have several visits to the clinic over a period of time, likely lasting for a number of months over at least one grass pollen season. During these visits, you'll have various checks and assessments related to your allergy. This will include skin prick tests to confirm your allergy and other ways to measure your hay fever symptoms and how much medication you use.

You will be given a spray to use under your tongue regularly, which will either be the active treatment or a placebo. You'll need to keep a daily diary of your symptoms and any other hay fever medicines you take. There might also be other tests, such as a nasal provocation test, where a small amount of pollen is introduced into your nose under controlled conditions to see your reaction. You'll be closely monitored throughout the study to ensure your safety and to track how well the treatment is working.

Potential risks and benefits

Participating in a study like this might offer potential benefits, such as receiving a new treatment that could reduce your hay fever symptoms and your need for other medicines. You'll also receive careful medical monitoring and contribute to valuable research that could help others with severe allergies. However, there are potential risks, including side effects from the treatment (which could be mild, like a tickle in the throat, or more significant). You might also experience discomfort from study procedures like skin tests or nasal provocation tests. Remember, you can 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
Germany

Common questions

What is `sublingual immunotherapy`?

It's a treatment where you take small amounts of what you're allergic to, like grass pollen, usually under your tongue as a spray or tablet. Over time, this helps your body become less sensitive to the allergen.

What is a `placebo`?

A placebo is a 'dummy' treatment that looks, smells, and tastes like the real treatment but doesn't contain any active ingredients. It helps researchers compare the real treatment's effects.

What are `hay fever symptoms`?

These are common allergy symptoms like sneezing, a runny or blocked nose, itchy or watery eyes, and an itchy throat, usually triggered by pollen.

What does `Phase II-III` mean?

In medical research, `Phase II` studies test if a treatment works and is safe in a small group of people. `Phase III` studies are larger and confirm if it's effective and safe compared to existing treatments or a placebo.

Can I continue my usual hay fever medicines?

The study will tell you which medications you can and cannot take. You might be asked to stop some standard treatments so researchers can clearly see the effect of the study treatment.