Efficacy and Safety of LAIS® Mites Sublingual Tablets (NCT02277483) | Clinical Trial Compass
UnknownPhase 4
Efficacy and Safety of LAIS® Mites Sublingual Tablets
South Korea45 participantsStarted 2014-10
Plain-language summary
Evaluation of the efficacy and safety of SLIT with LAIS® Mites Sublingual tablets compared to standard drug treatment in patients aged over 60 years suffering from house dust mite (HDM) induced allergic rhino-conjunctivitis with/without asthma.
Who can participate
Age range
60 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
. Female or male patients aged 60 years or more with a history of at least two years of house dust mite (HDM) induced allergic rhinitis and/or allergic rhinoconjunctivitis with or without mild to moderate controlled asthma upon exposure to house dust mite \[From the Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma (GINA) 2007.
. Clinically relevant sensitization to mites.
. Positive clinical history of allergy due to house dust mite (HDM), proven by- The majority of perennial clinical symptoms appearing mostly related to indoor mites allergens
. Retrospective Total Symptom Score (RRTSS) referred to the previous winter season greater than or equal to 8
. Compliance and ability of the patient to complete a diary card for self-evaluation of the symptoms and anti-symptomatic medication
. Signed and dated patient's Informed Consent
Exclusion criteria
. Simultaneous participation in other clinical trials
. Previous immunotherapy with mite allergens or cross reacting allergens within the last 5 years
. Ongoing immunotherapy with any allergen
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 being in any relationship or dependency with the sponsor and/or investigator
. Other reasons contra-indicating an inclusion into the trial according to the investigator's estimation (e.g. poor compliance, inability of the patient to understand study documents and instructions)
. Predominant seasonal allergic rhinitis
. Patients with clinically relevant sensitization to seasonal aero-allergens occurring during the study period may not be included. Also patients with clinically relevant sensitization to perennial allergens like animal dander may not be included