Safety and Clinical Tolerability of hdmASIT+TM Peptides Administered in HDM-induced Allergic Pati… (NCT03094845) | Clinical Trial Compass
CompletedPhase 2
Safety and Clinical Tolerability of hdmASIT+TM Peptides Administered in HDM-induced Allergic Patients
Germany36 participantsStarted 2016-09-28
Plain-language summary
hdmASIT+TM product is based on highly purified allergen fragments from house dust mites. The purpose of this study is to assess the safety and clinical tolerability of subcutaneous immunotherapy with hdmASIT+TM in patients with house dust mite-induced allergic rhinoconjunctivitis compared to placebo.
Who can participate
Age range
18 Years – 64 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:
* A medical history of moderate to severe allergic rhinoconjunctivitis for house dust mite for at least 12 months (definition of allergy severity according to ARIA (Bousquet et al., 2001))
* A positive skin prick test to house dust mite Dermatophagoides pteronyssinus
* Specific IgE against house dust mite Dermatophagoides pteronyssinus ≥ 0.7 kU/L
* Positive response to Conjunctival Provocation Test (CPT)
* Being treated with anti-allergic medication for at least 12 months prior to enrollment
* For asthmatic patients: confirmed diagnosis of controlled asthma according to Global Initiative for Asthma (GINA) guidelines (steps 1-3, GINA 2014), FEV1 ≥ 80% of the patient's reference value
Exclusion Criteria:
* Previous immunotherapy with house dust mite allergens within the last 5 years
* Ongoing immunotherapy with house dust mite allergens or any other allergens
* History of severe systemic reactions and/or anaphylaxis, including to food (e.g. peanut, marine animals) or to Hymenoptera venom (e.g. bee, wasp stings) or to medication (e.g. penicillin), etc.
* Partly controlled or uncontrolled asthma according to GINA guidelines (GINA 2014)
* Chronic asthma or emphysema, particularly with a forced expiratory volume in 1 second (FEV1) \< 80% of the patient's reference value (ECSC)
* History of a respiratory tract infection and/or exacerbation of asthma within 4 weeks before the screening
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.