This is a 2 year clinical study to compare 5-grass mix SLIT-drops with placebo in relieving grass pollen-induced rhinoconjunctivitis symptoms and in use of symptom-relieving medication during the second grass pollen season (peak grass pollen season, PGPS)
The study will collect health-related quality of life data in the groups treated with 5-grass mix SLIT-drops or with placebo during the first and second PGPS.
The trial medication used is already approved to treat allergic rhinitis caused by grass pollen in adults in several countries.
Who can participate
Age range
18 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female aged ≥18 years on the day informed consent is obtained
. A clinical history of grass pollen-induced allergic rhinoconjunctivitis for two years or more with or without asthma
. A clinical history of severe allergic rhinoconjunctivitis symptoms (interfering with usual daily activities or sleep) induced by grass pollen, which remain troublesome despite symptomatic treatment with antihistamines, nasal steroids or eye drops during the previous grass pollen season
. Positive specific immunoglobulin E (IgE) (defined as ≥class 2, ≥0.70 kU/l) against grass: Phleum pratense
. Positive skin prick test to Phleum pratense at screening
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Average Daily Allergic Rhinoconjunctivitis Total Combined Score (TCS) During the 2nd Peak Grass Pollen Season (PGPS)
. Has a clinically relevant history of symptomatic seasonal and/or perennial allergic rhinoconjunctivitis and/or asthma caused by an allergen other than grass pollen, to which the subject is exposed, which could potentially overlap with the efficacy assessment periods
. Within the last 3 months before the randomisation visit, has had an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalisation, or treatment with systemic corticosteroids
. SLIT treatment with any grass pollen AIT for more than 1 month within the last 5 years. In addition, any SLIT treatment with grass pollen AIT within the previous 12 months
. SCIT treatment with any grass AIT reaching the maintenance dose within the last 5 years. In addition, any SCIT treatment with grass AIT within the previous 12 months
. Ongoing treatment with any allergy immunotherapy product
. Uncontrolled or severe asthma requiring daily use of more than 800 mcg budesonide or equivalent at screening