Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Multicenter, double-blind, randomized, placebo-controlled phase III clinical trial in parallel groups which evaluates the clinical efficacy and safety of immunotherapy with the purified major allergen Cup a 1, in patients with moderate/severe allergic rhino conjunctivitis with or without controlled asthma, sensitized to Cupressaceae

This study is investigating a new treatment for individuals experiencing moderate to severe hay fever (allergic rhinoconjunctivitis), which may or may not include controlled asthma, caused by cypress tree pollen. The treatment is a type of immunotherapy using a purified substance called Cup a 1. The main goal is to find out if this treatment is effective and safe. Participants will be randomly assigned to receive either the active treatment or a placebo (a dummy treatment). Over two pollen seasons, researchers will track symptoms, medication use, and overall well-being using questionnaires. This will help determine if the new treatment can reduce hay fever symptoms and improve daily life compared to the placebo.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Diater Laboratorio De Diagnostico Y Aplicaciones Terapeuticas S.A.

Enrolment target

150

Start

19 Dec 2024

Allergic rhinoconjunctivitis

What is this study about?

This research study is looking into a new way to treat hay fever, specifically for those whose symptoms are moderate to severe and are triggered by cypress tree pollen. Hay fever is a common condition that can cause a runny nose, sneezing, itchy eyes, and generally make you feel unwell. Sometimes, it can also affect people who have asthma, making their asthma harder to control.

The treatment being tested is a type of immunotherapy. This isn't like taking a regular tablet when you have symptoms; instead, it aims to change how your body reacts to the pollen over time. It uses a purified substance called Cup a 1, which is a key part of the cypress tree pollen that causes allergic reactions. By giving small, controlled amounts of this substance, the hope is to train your immune system not to overreact when you come into contact with cypress pollen naturally.

This study is designed to be very thorough. Some people will receive the active treatment, while others will receive a 'placebo', which looks exactly the same but contains no active medicine. This helps researchers fairly compare the new treatment with doing nothing, ensuring any benefits seen are truly due to the active treatment and not just a placebo effect. The main aim is to see if this new treatment can make your hay fever symptoms less frequent and less severe over two full cypress pollen seasons.

Key takeaways

Tests a new immunotherapy for cypress pollen allergy.
Aims to reduce moderate/severe hay fever symptoms.
Involves questionnaires over two pollen seasons.
Compares active treatment to a placebo.
Open to adults 18+ with or without controlled asthma.
You won't know if you get the treatment or placebo.

Who may be eligible?

To join this study, you need to be an adult, 18 years or older. Both men and women can take part.

You must have moderate to severe hay fever symptoms specifically caused by cypress tree pollen. This means your allergy has been diagnosed, and your symptoms are quite noticeable.

If you also have asthma, it needs to be well-managed and under control. The study doctors will check this to make sure it's safe for you to participate.

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 have moderate to severe hay fever symptoms?
Is your hay fever specifically caused by cypress tree pollen?
If you have asthma, is it well-controlled?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned by chance to either receive the active treatment (Cup a 1) or a placebo (a dummy treatment that looks identical). The treatment will be given in the same way for everyone, though the exact details of how it's given, how often, and for how long would be fully explained by the study team.

You will need to regularly fill out questionnaires, especially during two cypress pollen seasons. These questionnaires will ask about your hay fever symptoms and how much other allergy medication you might be using (like antihistamines or nasal sprays). This helps the researchers understand if the study treatment is working.

The study will also involve some medical check-ups and tests. These might include skin prick tests to check your allergy, blood tests to look at your immune system, and assessments of your asthma control if you have asthma. You might also have brief appointments to check your eyes' reaction to pollen. The total length of your participation will cover two pollen seasons and the follow-up tests, which would be explained by the study team.

Potential risks and benefits

Taking part in a study like this might have potential benefits. If the treatment works, you could experience fewer and less severe hay fever symptoms, use less allergy medication, and generally feel better during pollen season. However, there's no guarantee the treatment will work for you, as some participants will receive a placebo. Potential risks could include side effects from the treatment, similar to other allergy treatments, which might include local reactions where the treatment is given, or possibly more general allergic reactions. All potential side effects would be fully explained before you agree to take part. You are free to 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
Spain

Common questions

What is 'immunotherapy'?

Immunotherapy is a treatment that aims to change how your immune system reacts to allergens like pollen, making it less sensitive over time.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks exactly like the real treatment but contains no active medicine. It helps researchers compare the true effects of the new treatment.

What is Cup a 1?

Cup a 1 is a specific purified substance found in cypress tree pollen that is known to trigger allergic reactions in people sensitive to it.

How long will I be in the study?

You will be in the study long enough to cover two full cypress pollen seasons, plus any follow-up appointments and tests. The study team will provide the exact timeline.

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

No, this is a 'blinded' study, meaning neither you nor the study doctors will know who is getting the active treatment or the placebo until after the study is complete. This helps ensure fair results.