Study of Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablets in Adult Patients … (NCT00955825) | Clinical Trial Compass
CompletedPhase 3
Study of Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablets in Adult Patients With Allergic Grass Pollen Rhinoconjunctivitis
United States473 participantsStarted 2008-10
Plain-language summary
The purpose of the study is to assess the efficacy and safety of 300 IR sublingual tablet of grass pollen allergen extract compared to placebo in adult patient with allergic rhinoconjunctivitis.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Grass pollen-related allergic rhinoconjunctivitis for at least the last two pollen seasons.
. Positive SPT to grasses
. Total symptoms score for the previous pollen season more than 12 out of 18.
. Patients with FEV1 ≥ 80% of the predicted value.
Exclusion criteria
. Positive SPT to other grasses present during the grass pollen season and if endemic to the region
. Patients with clinically significant confounding symptoms of allergy to other allergens potentially overlapping the grass pollen season
. Asthma requiring treatment with medications other than beta-2 inhaled agonists.
. Patients who have received any desensitization treatment for grass pollen in the past 5 years.
. Ongoing immunotherapy with any other allergen.
. Patients with any nasal or oral condition that could confound the efficacy or safety assessments
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.
. Patients with known history of hypersensitivity or intolerance to any of the excipients in the investigational product (such as lactose intolerance).
. Patients with any past or current clinically significant condition which as judged by the investigator, may affect the patient's participation or the outcome of the study.