Ongoing, recruitingPhase II and Phase III (Integrated)Interventional

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

This research study is investigating a new spray treatment for people with moderate to severe birch pollen allergy, often called hay fever. The spray is used under the tongue and aims to reduce typical allergy symptoms like sneezing, runny nose, and itchy eyes and throat. Researchers want to compare different strengths of this spray against a dummy spray (placebo) to see if it effectively lessens symptoms during the peak birch pollen season. They also want to check how safe it is to use. The study focuses on people who have suffered from these allergy symptoms for at least two years. The results will help understand if this sublingual immunotherapy could be a good treatment option.

At a glance

Status

Ongoing, recruiting

Phase

Phase II and Phase III (Integrated)

Sponsor

ROXALL Medizin GmbH

Enrolment target

Start

22 Aug 2023

Moderate-to-severe allergic rhinitis / rhinoconjunctivitis due to birch 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 looking into a new way to treat hay fever caused by birch pollen. If you suffer from a stuffy or runny nose, sneezing, or itchy eyes because of birch pollen, this study might be of interest. The treatment being tested is called "sublingual immunotherapy." This simply means a treatment you take as a spray under your tongue. The idea is that over time, your body will get used to the birch pollen, making your allergic reactions less severe. This type of treatment is similar to allergy shots, but instead of injections, you use a spray at home.

The main goal of the study is to see if this spray treatment can make a real difference in people's symptoms during the worst of the birch pollen season. Researchers will compare people who use the active spray to those who use a dummy spray, which looks and tastes the same but contains no active ingredient. This comparison helps them understand if any improvements are truly due to the treatment, or if they happen naturally or because people expect to feel better.

They will measure various things to see how well the treatment works. This includes tracking daily allergy symptoms and the amount of allergy medicine people need to take. They'll also look at how the treatment affects participants' quality of life and conduct some tests to see if their bodies' allergic responses change. Safety is also a top priority, so they'll carefully monitor for any side effects from the spray.

Key takeaways

This study tests a new birch pollen allergy spray used under the tongue.
It aims to see if the spray reduces hay fever symptoms and is safe.
Participants will record their symptoms and medicine use.
The study compares the active treatment to a dummy spray (placebo).
Close medical monitoring is provided throughout the study.

Who may be eligible?

To join this study, you generally need to be an adult, aged 18 or over. There's no upper age limit listed.

Key to eligibility is that you must have experienced moderate to severe hay fever symptoms, like sneezing, runny nose, or itchy eyes, specifically due to birch pollen for at least the past two years. This would typically be confirmed by your doctor and perhaps some allergy tests.

The study involves both men and women.

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 birch pollen, usually for at least 2 years?
Have you been diagnosed with birch pollen allergy by a doctor?
Are you able to attend several clinic visits for tests and check-ups?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regularly using a spray under your tongue. You would be given either the active birch pollen treatment in a low, medium, or high dose, or a dummy spray (placebo). You wouldn't know which one you're getting. You would also be asked to keep a daily record of your allergy symptoms and any other allergy medicines you take, especially during the birch pollen season.

There will be several visits to the study clinic over a period that covers the birch pollen season. These visits will involve various tests, such as skin prick tests to check your allergy reactions and possibly a nasal test where a small amount of birch pollen is introduced to see your body's response. You might also fill out questionnaires about how your allergy affects your daily life. The total duration of participation in the study is not specified but would likely span several months to cover the full pollen season and follow-up assessments.

Potential risks and benefits

Participating in a study like this might offer the benefit of potentially reducing your birch pollen allergy symptoms if you receive the active treatment. Even if you receive the placebo, you'll be closely monitored by medical professionals. However, there are potential risks, such as side effects from the treatment, which could include local reactions like an itchy mouth or throat, or other allergic reactions. As with any medical study, there's a chance the treatment might not work for you, or you might experience discomfort. You are always free to stop participating in 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 birch pollen allergy?

It's a type of hay fever caused by the pollen from birch trees, leading to symptoms like sneezing, runny nose, and itchy eyes in spring.

What does 'sublingual immunotherapy' mean?

It's a treatment where you take a small amount of the allergen (like birch pollen) under your tongue, usually as a spray or tablet, to help your body get used to it and react less strongly.

Will I know if I'm getting the real treatment or a dummy spray?

No, this is a 'blinded' study, meaning neither you nor the study team will know whether you're receiving the active treatment or a dummy spray. This helps ensure fair results.

Do I have to stop taking my usual allergy medicines if I join?

You'll be guided on what medicines you can take. Some 'rescue' medications (for sudden symptoms) might be allowed as part of tracking how well the study treatment works.

How long will the study last?

The exact duration isn't specified, but it would involve monitoring you through at least one full birch pollen season and follow-up, likely several months.