Standardized Phleum pratense in TBU/ml in liquid formulation for sublingual immunotherapy: Phase II, randomized dose determination clinical trial. DEDO-G Study.
This research study, called the DEDO-G Study, is testing a new liquid medicine for people aged 18 and over who suffer from allergic rhinitis or hay fever caused by grass pollen. The medicine is taken under the tongue. The main goal is to figure out the most effective dose. We're comparing different strengths of the medicine (3000 TBU/ml, 1000 TBU/ml, and 6000 TBU/ml) against a dummy treatment (placebo). Researchers will check how each person reacts to a special nose test and track their symptoms to see if the medicine helps reduce their allergies. Safety is also a key focus.
At a glance
What is this study about?
This study is investigating a new way to treat hay fever caused by grass pollen, which medically is known as allergic rhinitis or rhinoconjunctivitis. If you experience sneezing, a runny nose, itchy or watery eyes, or other similar symptoms when grass pollen is in the air, this study might be relevant to you. The new treatment is a liquid medicine that you take by putting it under your tongue. This type of treatment aims to help your body get used to the allergen (in this case, grass pollen) so it reacts less strongly over time.
The main purpose of this particular study, called the DEDO-G Study, is to find out the best dose of this new liquid medicine. To do this, some participants will receive a dummy treatment (called a placebo), while others will receive one of three different strengths of the active medicine. By comparing these groups, the researchers hope to identify which dose is most effective at reducing allergy symptoms and improving how participants react to grass pollen.
To see how well the treatment works, the study will use a special 'nasal provocation test'. This involves introducing a small amount of grass pollen into the nose and then measuring how much air you can breathe in through your nose. They will also keep track of your allergy symptoms. This will help them understand if the medicine is making a real difference to your hay fever reactions and how you feel generally.
Key takeaways
- Tests a new liquid medicine for grass pollen allergy, taken under the tongue.
- Aims to find the best dose to reduce hay fever symptoms.
- Compares different strengths of the medicine against a dummy treatment (placebo).
- Uses a special nose test and symptom tracking to see how well it works.
- Participants must be 18 or over and have grass pollen allergies.
- Study includes regular clinic visits and monitoring for safety.
Who may be eligible?
To be considered for this study, you must be 18 years old or older. The study welcomes both men and women.
The main requirement is that you have allergic rhinitis or hay fever symptoms that are specifically caused by grass pollen. This means your allergies get worse when grass pollen is in the air.
There might be other health conditions or medications that would prevent you from joining, but these will be discussed in detail by the study team if you are interested.
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 get hay fever symptoms (like sneezing, runny nose, itchy eyes) during grass pollen season?
- Are your allergy symptoms mainly caused by grass pollen?
- Are you willing to attend regular clinic visits for tests and assessments?
What does participation involve?
If you join this study, you will be randomly assigned to receive either the new liquid medicine at one of three different strengths, or a placebo (a dummy treatment that looks and feels like the medicine but contains no active ingredient). You won't know which one you are receiving. The medicine is taken by placing it under your tongue.
During the study, you will have regular visits to the clinic. These visits will involve various checks, including a special "nasal provocation test." This test involves putting a small amount of grass pollen into your nose, and then measuring how well you can breathe through your nose using a small portable device. Your allergy symptoms will also be carefully monitored and recorded.
Researchers will also take blood samples at the beginning and end of the study to look at certain markers related to your allergy. You might also have a skin prick test for grass pollen. You will be asked to track any other allergy medications you use over the course of the study. The total duration of your participation in the study, including all visits and follow-up, will be explained by the study team.
Potential risks and benefits
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Common questions
What is 'sublingual immunotherapy'?
It's a treatment where you take a small amount of an allergen (like grass pollen) under your tongue to help your body become less sensitive to it over time.
What is a 'placebo'?
A placebo is a dummy treatment that looks just like the real medicine but contains no active ingredients. It helps researchers see if the real medicine is actually working.
What is a 'nasal provocation test'?
This test involves putting a tiny, controlled amount of grass pollen into your nose to see how your body reacts and how that reaction changes with the treatment.
Will I know if I'm getting the active medicine or the placebo?
No, this is a 'blinded' study, meaning neither you nor the study team will know what treatment you are receiving until the study is over. This helps ensure fair results.
What does 'TBU/ml' mean?
TBU/ml is a way to measure the strength or concentration of the active ingredient in the liquid medicine. It's similar to how 'milligrams' measure strength in other medicines.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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