Prospective, multicenter, randomized, double-blind, placebo-controlled, efficacy and safety clinical trial with subcutaneous immunotherapy in patients with rhinitis/rhinoconjunctivitis with or without mild to moderate asthma sensitized to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae
This study is investigating a potential new treatment for allergies caused by dust mites (Dermatophagoides pteronyssinus and/or Dermatophagoides farinae). It focuses on people who experience moderate to severe hay fever (allergic rhinitis/rhinoconjunctivitis) and may also have mild to moderate asthma that is well-controlled. The treatment is given as an injection under the skin (subcutaneous), and the study wants to find out how well it works to reduce allergy symptoms and the amount of medication people need to take. It will also look at how safe the treatment is. This is a crucial step to confirm if this treatment could be helpful for many people suffering from these common allergies.
At a glance
What is this study about?
This research study is looking into a new way to treat common allergies, specifically those caused by dust mites. Many people in the UK suffer from allergic rhinitis, often known as hay fever, which can cause sneezing, a runny nose, itchy eyes, and generally make you feel quite unwell. Some people with these allergies also have asthma that is mild or moderate and can be managed with current treatments. This study is trying to find an 'aetiological' treatment, which means it aims to address the root cause of the allergy, not just the symptoms.
The treatment being tested is called 'Clustoid MM09' and it's a type of immunotherapy. This kind of treatment works by gradually training your immune system to be less reactive to the things that trigger your allergies, like dust mites. It's given as an injection under the skin. Half of the participants in the study will receive this active treatment, while the other half will receive a placebo, which looks identical but doesn't contain the active ingredient. This is a common and important way to fairly test if the new treatment really makes a difference.
The main goal of the study is to see if Clustoid MM09 can effectively reduce the symptoms of hay fever and asthma, and if people need to take less allergy medication as a result. Researchers will compare how people feel at the start of the study to how they feel at the end. They'll also be carefully checking for any side effects to make sure the treatment is safe.
Key takeaways
- This study tests an injection treatment for dust mite allergies.
- It's for people with moderate to severe hay fever, possibly with mild asthma.
- The aim is to reduce symptoms and the need for allergy medication.
- Participants will either receive the active treatment or a placebo.
- Safety is a key focus, with close monitoring for side effects.
Who may be eligible?
To join this study, participants generally need to be adults aged 18 or older. The study is open to both men and women.
Crucially, you would need to have moderate to severe hay fever (allergic rhinitis/rhinoconjunctivitis) that occurs often or all the time. Your allergy symptoms must be caused by dust mites, which would be confirmed by allergy tests.
If you also have asthma, it needs to be mild to moderate and well-controlled with your current treatments. The study is not for people with severe asthma or those whose asthma is not well managed.
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 (allergic rhinitis/rhinoconjunctivitis)?
- Are your allergies confirmed to be caused by dust mites?
- If you have asthma, is it mild to moderate and well-controlled?
What does participation involve?
If you decide to take part in this study, you would likely have a number of visits to a clinic over a period of time. At these visits, you would receive injections of either the study treatment or a harmless dummy treatment (placebo). You would be asked to track your allergy symptoms and any medication you take in a diary.
Researchers will also ask you to fill out questionnaires about your quality of life and how your symptoms affect you. There will be blood tests to check your allergy markers. They will also keep a close eye on any reactions you might have to the injections or any other health changes, to make sure you are safe. The total length of your participation would be confirmed by the study team.
Potential risks and benefits
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Common questions
What kind of allergies is this study for?
This study is for people with moderate to severe hay fever symptoms, sometimes with mild asthma, caused by allergies to dust mites.
What is 'immunotherapy'?
Immunotherapy is a treatment that helps your body become less sensitive to allergens, like dust mites, over time.
Will I know if I'm getting the real treatment or a dummy one?
No, this is a 'double-blind' study, meaning neither you nor your doctors will know if you're receiving the active treatment or a placebo until the study is over.
What is the study medication called?
The study medication is called Clustoid MM09.
How will the study check if the treatment works?
The study will track your symptoms and how much allergy medication you use, and compare them from the start to the end of the study.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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