The main objective of the study is to measure and correlate clinical parameters suitable for the assessment of allergen immunotherapy (AIT) with an aluminum hydroxide-adsorbed preparation of house dust mite (Dermatophagoides pteronyssinus/ Dermatophagoides farinae) allergens in adults with moderate to severe allergic rhinitis/rhinoconjunctivitis with or without controlled allergic bronchial asthma caused by house dust mite (HDM) allergens. The assessment of clinical responses will be evaluated following an allergen challenge in allergen exposure chamber (AEC) before and during the course of AIT. Patients' response to therapy will be evaluated as well as in the AEC and by patient's personal environment (Diary).
Written informed consent given from patient according to local requirements before any trial-related activities started (a trial-related activity is any procedure that would not have been performed during the routine management of the patient)
Legally competent male or female outpatient between 18 and ≤ 65 years
IgE-mediated moderate to severe allergic rhinitis or rhinoconjunctivitis with or without allergic asthma caused by HDM allergens documented by
Symptoms of rhinitis or rhinoconjunctivitis e.g., during the months October to February or over the entire year for at least 2 years before enrolment.
Patients are unable to understand and comply with the requirements of the trial, as judged by the investigator
Currently participating in another clinical trial or participating in any other clinical trial within 30 days prior informed consent for this trial
Low adherence to trial procedures expected or inability to understand instructions/trial documents
Involvement in the planning and conduct of the trial
Wroclaw Medical University
Lead sponsor
ALL-MED Medical Research Institute, Wroclaw, Poland
Collaborator
Allergopharma GmbH & Co. KG
Collaborator