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Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Phleum pratense and Dactylis glomerata allergen extracts. Determination of the in vivo histamine equivalent prick test units.

This study is looking into a new method for testing allergies to two common types of grass pollen: Timothy grass (Phleum pratense) and Orchard grass (Dactylis glomerata). Researchers are using a standard skin prick test to see how the skin reacts to different strengths of these pollens. They will compare these reactions to what happens with a known irritant (histamine) and plain water, to get a clear picture. The main goal is to find a reliable way to measure the size of the allergic skin reaction. This information is important because it can help doctors give more accurate allergy diagnoses and potentially improve future allergy treatments for people bothered by grass pollen.

At a glance

Status
Ongoing, recruiting
Phase
Therapeutic exploratory (Phase II)
Sponsor
Inmunotek S.L.
Enrolment target
30
Start
06 Nov 2024

What is this study about?

This study is focusing on allergies to two common types of grass pollen: Timothy grass and Orchard grass. If you suffer from hay fever or other allergic reactions to these grasses, this research might be of interest. The main idea behind the study is to find a precise way to measure how your body reacts to these pollens.

Researchers will be using a very common test called a skin prick test. This is where a tiny drop of liquid containing the pollen extract is placed on your skin, and then the skin is gently pricked through the drop. They will test different strengths of the pollen extracts to see how your skin reacts. They'll also use a positive control (histamine, which always causes a small bump) and a negative control (plain water, which shouldn't cause a reaction) to make sure the results are accurate.

The main thing the study wants to find out is the size of the 'wheal' – the small, itchy bump that appears on your skin where the pollen was applied. By carefully measuring these bumps, the researchers hope to develop a better and more consistent way to understand and treat grass pollen allergies in the future.

Key takeaways

  • Tests a new way to measure grass pollen allergy reactions.
  • Uses a common skin prick test method.
  • Specifically focuses on Timothy grass and Orchard grass pollens.
  • Aims to improve allergy diagnosis and future treatments.
  • Suitable for adults aged 18 and over with these specific allergies.

Who may be eligible?

To take part in this study, you need to be an adult, 18 years old or older. There is no upper age limit, meaning people of all adult ages can be considered. Both men and women are welcome to participate.

The most important requirement is that you have a known allergy to Timothy grass (Phleum pratense) and Orchard grass (Dactylis glomerata). This study is specifically looking at how your skin reacts to these particular types of pollen.

Beyond simply having the allergy, the research team will check other health details to make sure the study is safe and suitable for you. They will explain all the specific criteria during the screening process.

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.

  1. Are you 18 years old or older?
  2. Do you have a confirmed allergy to Timothy grass (Phleum pratense)?
  3. Do you have a confirmed allergy to Orchard grass (Dactylis glomerata)?
  4. Are you able to attend appointments at the study clinic?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you will have a skin prick test. This involves a small amount of liquid containing different strengths of grass pollen extracts being placed on your arm. Your skin will then be gently pricked through these drops. The researchers will also use a positive control (histamine, which causes a small, temporary bump) and a negative control (plain water) for comparison.

After the skin pricks, the medical team will carefully measure the size of any red, itchy bumps (called wheals) that appear. They will also keep a close eye on you for any side effects, like skin reactions at the test site or any other general effects such as feeling unwell. They will ask you if you needed any medicine to treat any reactions. The total duration of your involvement could be completed in a single visit, but this will be fully explained to you.

Potential risks and benefits

Participating in this study will help scientists better understand grass pollen allergies, which could lead to improved diagnosis and treatment for many people in the future. The main risks involve the skin prick test itself, which can cause temporary redness, itching, and small bumps at the test sites, similar to your usual allergic reactions. These reactions are usually mild and temporary. More severe reactions are rare, but the study team will be prepared to manage them. 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 is a skin prick test?

A skin prick test is a common way to check for allergies. A tiny drop of allergen (like pollen) is put on your skin, which is then gently pricked. If you're allergic, a small, itchy bump usually appears.

What are 'Phleum pratense' and 'Dactylis glomerata'?

These are the scientific names for two very common types of grass pollen: Timothy grass and Orchard grass. They are a frequent cause of hay fever and other allergic reactions.

Why are you measuring the 'wheal' on my skin?

The 'wheal' is the small, raised, itchy bump that forms when your skin reacts to an allergen. Measuring its size helps researchers understand how strongly your body reacts to different pollens and different strengths of those pollens.

Do I need to stop my allergy medication before the test?

This is a very important question to discuss with the study team. Often, certain allergy medications need to be stopped a few days before a skin prick test to ensure accurate results. They will give you specific instructions.

Will I get paid for taking part?

Payment for participation varies between studies. You should ask the research team directly about any reimbursement for travel expenses or your time.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

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