AuthorisedTherapeutic confirmatory (Phase III)Interventional

A randomised, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of PQ Birch in subjects with seasonal allergic rhinitis and/or rhinoconjunctivitis induced by birch pollen exposure

This study is a research trial looking into a new medication for people who suffer from hay fever (allergic rhinitis) or itchy, watery eyes (rhinoconjunctivitis) specifically caused by birch tree pollen. Researchers want to see how well this new treatment, called PQ Birch, works compared to a 'dummy' treatment (placebo). They will also carefully check for any side effects to make sure it's safe. This type of study, called a Phase 3 trial, is an important step before a new medicine can be widely used. The main goal is to find out if the treatment significantly helps reduce hay fever symptoms during the peak birch pollen season, and to understand its overall safety.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Allergy Therapeutics (UK) Limited

Enrolment target

562

Start

22 Oct 2024

seasonal allergic rhinitis and/or rhinoconjunctivitis

What is this study about?

This study is all about finding a better way to treat hay fever that's triggered by birch pollen. Many people in the UK suffer from watery eyes, sneezing, and a runny nose when birch trees are releasing their pollen, and this trial aims to test a new treatment designed to calm those allergic reactions.

Researchers are comparing this new treatment, called PQ Birch, with a 'placebo.' A placebo looks just like the real treatment but doesn't actually contain any active medicine. This comparison is really important because it helps scientists understand if any improvements people feel are truly due to the new medication, or if they're happening for other reasons, like the 'placebo effect' where people feel better just by expecting to get treatment.

By carefully checking symptoms and safety, the study hopes to show whether PQ Birch could be a helpful and safe option for people struggling with birch pollen allergy, potentially offering them more relief during the hay fever season.

Key takeaways

The study is investigating a new treatment for birch pollen hay fever.
It compares the new treatment with a dummy treatment (placebo).
Safety is a key focus, alongside how well the treatment helps symptoms.
Participation involves injections and tracking your symptoms.
The study is for adults aged 18 and older who suffer from birch pollen allergy.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

The most important thing is that you regularly suffer from hay fever symptoms like sneezing, a runny nose, or itchy eyes specifically when birch trees are releasing their pollen in the air. This means you have a confirmed allergy to birch pollen.

There will be other specific health requirements that the study doctors will discuss with you to make sure the study is safe and suitable for your individual circumstances.

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 hay fever (sneezing, runny nose, itchy eyes) specifically from birch pollen?
Are you able to attend several clinic visits?
Are you comfortable with having injections under your skin?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be assigned to either receive the new treatment (PQ Birch) or a dummy treatment (placebo) by injection under your skin. You won't know which one you're getting, and neither will your study doctor, to keep the results fair.

You'll have several visits to the clinic where doctors will check your general health, take blood and urine samples, and measure your vital signs like blood pressure. You’ll also be asked to keep track of your hay fever symptoms, like sneezing and itching, in a diary during pollen season.

The study will likely involve regular check-ups over several months, especially before, during, and after the birch pollen season. There will also be a follow-up visit to ensure your well-being after treatment.

Potential risks and benefits

Taking part in a study like this might offer you a chance to receive a new treatment for your birch pollen allergy before it's widely available, which could potentially relieve your symptoms. However, there's also a chance you could receive the placebo and not the active medication. Potential risks include discomfort or reactions at the injection site, and possibly side effects from the medication itself, though these will be closely monitored. You will be told about all known risks before you decide to join, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

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Unverified
Austria
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Unverified
Germany
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Unverified
Poland

Common questions

What is 'seasonal allergic rhinitis'?

It's the medical name for hay fever, which gives you symptoms like a runny nose, sneezing, and itchy eyes, usually at certain times of the year due to pollen.

What does 'placebo-controlled' mean?

It means some people in the study will get the actual treatment, while others will get a 'dummy' treatment that looks the same but contains no medicine. This helps researchers see if the real treatment works.

What is birch pollen?

It's the tiny dust-like particles released by birch trees, which cause allergic reactions (hay fever) in many people during spring.

Will I know if I'm getting the real medicine or the placebo?

No, neither you nor the study doctor will know. This is called 'double-blind' and makes sure the study results are fair and unbiased.

What is a 'Phase III' trial?

This is an advanced stage of research where a new treatment is tested on a larger group of people to confirm its effectiveness and safety before it can be approved for general use.