Prospective, randomised, double-blind, placebo-controlled multicenter clinical trial to evaluate efficacy and safety of immunotherapy in patients with rhinitis/rhinoconjunctivitis with or without mild to moderate asthma, allergic to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae and Lepidoglyphus destructor.
This study is looking for adults with moderate to severe dust mite allergies, which might also include mild asthma. It's investigating an injection treatment to see how well it works and if it's safe. Half the participants will receive the active treatment, which helps their body get used to the dust mites, and the other half will get a dummy injection (placebo) that looks the same but contains no active medicine. Researchers will track symptoms like sneezing, runny nose, and asthma issues over a year using a diary. They will also check for any side effects. This is a very important step to see if this treatment can help people feel better and improve their quality of life.
At a glance
What is this study about?
If you suffer from allergies to dust mites, you'll know how disruptive symptoms like a runny nose, itchy eyes, and sneezing can be. Sometimes these allergies can also lead to mild asthma. This study is exploring a new injection treatment, a type of 'allergy shot' (immunotherapy), designed to help your body become less sensitive to dust mites.
The main aim of this study is to see if this new treatment can significantly reduce the symptoms of dust mite allergy and improve your overall well-being. Researchers will be comparing it to a 'dummy' injection, known as a placebo. This helps them understand whether any improvements are truly due to the active medication or other factors. Both you and your doctor won't know whether you are receiving the active treatment or the placebo, which is a standard way to make sure the results are as fair and accurate as possible.
Throughout the study, you'll be asked to keep a diary to track how your symptoms change over time. The study will also be looking at how the treatment might affect your quality of life, how often you need to use other allergy or asthma relievers, and, importantly, what side effects, if any, you might experience. This information will help doctors understand if this treatment could become a helpful option for people like you in the future.
Key takeaways
- This study tests an injection for dust mite allergies and mild asthma.
- It compares an active treatment to a dummy injection (placebo).
- Participation involves regular injections, diary keeping, and clinic visits.
- The study aims to see if the treatment reduces symptoms and is safe.
- All adults (18+) with moderate to severe dust mite allergies are invited.
- You won't know if you're getting the active treatment or placebo.
Who may be eligible?
This study is looking for adults aged 18 or older. Both men and women can take part.
You would be considered for this study if you have moderate to severe allergies to dust mites, which can cause symptoms like sneezing, a runny nose, itchy eyes, and generally feeling unwell (rhinitis/rhinoconjunctivitis). You might also have mild to moderate asthma that is currently well-managed.
There might be other health conditions or medications that would mean this study isn't right for you. The study team will review your medical history carefully 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 allergies to dust mites?
- Do you have mild to moderate asthma that is currently controlled?
- Are you willing to attend regular clinic visits and keep a diary for over a year?
- Are you able to travel to the study clinic?
What does participation involve?
If you decide to take part, you would receive regular injections over one year. These injections will either contain the active treatment or a dummy medicine. You'll be asked to keep a daily diary to record your allergy and asthma symptoms and any medication you use. There will also be scheduled visits to the clinic for medical check-ups, blood tests, and to fill out questionnaires about how you're feeling and how the treatment is affecting your daily life. The study team will explain exactly how often these visits are and what they will involve. The total duration of your participation will be just over one year, including follow-up after your last injection.
Potential risks and benefits
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Common questions
What is a 'dust mite allergy'?
A dust mite allergy happens when your body reacts to tiny bugs called dust mites, causing symptoms like sneezing, a runny nose, and itchy eyes.
What does 'immunotherapy' mean?
Immunotherapy is a type of treatment that helps your body get used to things you're allergic to, making your symptoms less severe over time.
What is a 'placebo'?
A placebo is a dummy injection or treatment that looks exactly like the real thing but doesn't contain any active medicine. It helps researchers accurately test the new treatment.
Will I know if I'm getting the real treatment or the placebo?
No, neither you nor your doctor will know during the study. This is called 'double-blind' and ensures the results are fair and unbiased.
How long will I be in the study?
Your participation in the study will last for just over one year, including a period of follow-up after your last treatment.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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