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 range18 Years – 64 Years
SexALL
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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:
* 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