A Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Study to Assess the Efficacy of PURETHAL Mites Mixture 50,000 AUeq/mL Subcutaneous Immunotherapy in Adult Subjects With Moderate to Severe Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma Induced by House Dust Mite (HDM)
This study is looking at a new injection treatment called PURETHAL Mites. It's designed for adults aged 18-65 who suffer from moderate to severe allergies to house dust mites, which can cause symptoms like a runny nose, sneezing, and itchy eyes. Some participants in the study may also have asthma that is well-controlled. The main goal is to find out if this treatment is effective at reducing these allergy symptoms over a year compared to a dummy treatment (placebo). Researchers also want to make sure the treatment is safe. If successful, this could offer a new way to manage house dust mite allergies more effectively.
At a glance
What is this study about?
Many people in the UK suffer from allergies, and house dust mites are a common trigger. These tiny creatures can cause symptoms like sneezing, a runny nose, itchy eyes (doctors call this allergic rhinitis/rhinoconjunctivitis), and can also worsen asthma for some people. This can really impact daily life, making it hard to concentrate, sleep, or just feel well.
At the moment, treatments often focus on managing the symptoms, for example, with antihistamine tablets or nasal sprays. However, this study is testing a different type of treatment – an injection called PURETHAL Mites. This treatment is a type of 'allergy jab' or immunotherapy, which works by gradually helping your body get used to the dust mite allergens. The hope is that over time, your body will react less strongly when it comes into contact with actual dust mites, leading to fewer and less severe allergy symptoms.
This study is a 'Phase 3' trial, which means it's one of the final steps before a new treatment might become widely available. Researchers are carefully comparing PURETHAL Mites to a 'dummy treatment' (placebo) to make sure any improvements seen are definitely due to the treatment and not just chance. They will be looking closely at how much symptoms improve and also checking for any side effects to ensure the treatment is safe. Taking part in studies like this is really important for finding better ways to help people living with allergies.
Key takeaways
- Tests an injection for house dust mite allergy.
- For adults aged 18-65 with moderate to severe symptoms.
- Compares treatment to a 'dummy' injection over one year.
- Aims to reduce allergy symptoms and check safety.
- Involves regular clinic visits and daily symptom diaries.
- Participation helps future allergy treatments.
Who may be eligible?
To join this study, you need to be an adult between 18 and 65 years old. You should have had moderate to severe allergic reactions to house dust mites for at least a year. These allergies should cause symptoms mainly in your nose or eyes, and you might also have well-controlled asthma.
Before you can join, doctors will do tests to confirm your house dust mite allergy. This includes skin prick tests and blood tests. You'll also need to keep a diary of your symptoms for two weeks to show your allergy is active enough for the study. Your lung health will also be checked, and if you have asthma, it needs to be stable and not severe.
Important note: You won't be able to join if you have other serious ongoing health problems or if you take certain medications that could interfere with the study treatment or put your health at risk. The research team will review your full medical history 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 between 18 and 65 years old?
- Do you have moderate to severe allergy symptoms from house dust mites?
- Have you had these symptoms for at least a year?
- Is any asthma you have well-controlled?
- Are you able to attend regular clinic appointments?
- Are you willing to complete daily symptom diaries?
What does participation involve?
If you join the study, you'll be involved for about 14 months. This will include regular visits to a clinic. You'll be randomly put into one of two groups: one receiving the PURETHAL Mites injections and the other receiving a 'dummy' injection (placebo). Neither you nor the study doctors will know which treatment you are getting, and this helps make the results fair.
The main part of the treatment will last for one year, during which you will receive regular injections. You'll also be asked to keep a daily diary of your allergy symptoms and any medications you take. Towards the end of the year, over an 8-week period, your symptom scores from this diary will be carefully checked to see if the treatment has made a difference. There will also be blood tests and questionnaires to assess your allergy and quality of life. The research team will explain all the visits and procedures in detail before you decide to take part.
Potential risks and benefits
Locations (68)
- UMBAL KaspelaVerified postcodePlovdiv, Bulgaria
- Medical Center Prolet EOODVerified postcodeRousse, Bulgaria
- Medical Center SmolyanVerified postcodeSmolyan, Bulgaria
- DCC ConvexVerified postcodeSofia, Bulgaria
- Diagnostic-Consulativ Senter AscendentVerified postcodeSofia, Bulgaria
- University Hospital AlexandrovskaVerified postcodeSofia, Bulgaria
- Emovis GmbHVerified postcodeBerlin, Germany
- Praxis Dr. GinkoVerified postcodeBonn, Germany
- Praxis Dr. Elke DecotVerified postcodeDreieich, Germany
- HNO-Praxis Dr. Udo SchäferVerified postcodeDresden, Germany
- HNO Praxis Dr. Uta ThiemeVerified postcodeDuisburg, Germany
- Medizentrum Essen-BorbeckVerified postcodeEssen, Germany
Common questions
What is a 'placebo'?
A placebo is a 'dummy' treatment that looks just like the real one but doesn't contain any active medicine. This helps researchers fairly compare the new drug's effects.
Will I know if I'm getting the real treatment or the placebo?
No, neither you nor the study doctors will know which treatment you are receiving. This is called 'double-blind' and helps ensure the study results are unbiased.
What is 'allergic rhinitis/rhinoconjunctivitis'?
This is the medical term for allergy symptoms affecting your nose (like sneezing, runny nose, congestion) and eyes (like itchiness, watering).
What is a 'skin prick test'?
A skin prick test involves placing a tiny drop of allergen on your skin and gently pricking it. If you're allergic, a small red bump will appear, similar to a mosquito bite.
How long will I be in the study?
The study will last for approximately 14 months from when you join.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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