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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
36
15 injections over 7 weeks
15 injections over 7 weeks
Universitätsklinikum Carl Gustav Carus
Dresden, Germany
Solicited adverse events
* Local reactions at the injection site * Allergic systemic reactions
Time frame: up to 7 weeks
Unsolicited adverse events and serious adverse events (SAEs)
Time frame: up to 12 weeks
Physical examinations (body systems) and vital signs (heart rate, systolic and diastolic blood pressure)
Time frame: up to 12 weeks
Laboratory investigations (haematology, clinical biochemistry, immunological parameters)
Time frame: up to 12 weeks
Pulmonary functions (FEV1) for asthmatic patients
Time frame: up to 7 weeks
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