Safety and Clinical Tolerability of hdmASIT+TM Peptides Administered in HDM-induced Allergic Patients

Launched by ASIT BIOTECH S.A. · Mar 23, 2017

Keywords

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ALL

Eligibility criteria

• 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