purethal® mites dose range finding study in patients with persistent allergic rhinitis/rhinoconjunctivitis

Conditions: Allergic Rhinitis; Allergic Rhinoconjunctivitis

Summary: the objective of the present study is to characterize the dose-response relationship of purethal® mites with a nasal provocation test in order to support the optimal dose in terms of clinical efficacy and safety. for this purpose 5 groups of 50 patients, suffering from rhinitis or rhinoconjunctivitis due to house dust mite allergy will be treated during 1 year. before start, after 6 months of treatment and at the end of the study patients will be subjected to a nasal provocation test.


Eligibility criteria:
inclusion criteria: * signed informed consent * patients (male or female) must be ≥ 18 and ≤ 60 years at screening * patients with allergic rhinitis or rhinoconjunctivitis for at least 1 year; allergic symptoms related to hdm, with or without concomitant clinically stable controlled mild to moderate asthma (according to gina classification) * patients with a history of concomitant asthma should have a fev1 \> 70% at inclusion. patients without a history of asthma should have a fev1 \> 70% or a pef \> 80%. * positive spt to hdm d. pter and/or d. far * serum specific ige-test (ssige) level for hdm d. pter or d. far at screening * positive nasal provocation test for hdm extract at screening exclusion criteria: * current clinically relevant symptoms of seasonal rhinitis/rhinoconjunctivitis caused by other allergen(s) than hdm (with a demonstrated positive spt for this allergen) at the time of inclusion * patients sensitized to animals should not be included if they are symptomatic upon exposure and regularly exposed to animals * completed allergen-specific immunotherapy (scit or slit) with hdm within the last 5 years * completed unsuccessful allergen-specific immunotherapy (scit or slit) within the past 5 years * allergen-specific immunotherapy (scit or slit) with other allergens than hdm during the study period * any vaccination one week before start of therapy and during the up-dosing phase * any anti-ige therapy within the last 6 months prior to inclusion and during study * severe immune disorders (including auto-immune diseases) and/or diseases requiring immunosuppressive drugs * active malignancies or any malignant disease in the past 5 years * a chronic or acute disease that in the opinion of the investigator might place the patient at an additional risk, including but not limited to the following: cardiovascular insufficiency, any severe or unstable lung diseases, endocrine disorders, clinically significant renal or hepatic diseases, or haematological disorders * moderate to severe nasal obstructive diseases such as polyps, septal deviations etc. * clinically significant chronic sinusitis or ocular infection * diseases with a contra-indication for the use of adrenaline (e.g. hyperthyroidism, glaucoma) * use of systemic corticosteroids within 4 weeks of screening * treatment with systemic or local b-blockers * participation in a clinical study with a new investigational drug within the last 3 months or a biological within the last 6 months prior to the study or during the study * pregnancy, lactation or inadequate contraceptive measures (contraceptive measures considered as adequate include appropriate use of oral contraception, i.m. contraception or a contraceptive device) * alcohol, drug, or medication abuse within the past year and during study * any abnormal laboratory parameter at screening that in the opinion of the investigator is considered clinically relevant * lack of co-operation or compliance * severe psychiatric, psychological, or neurological disorders * patients who are employees of the department, 1st grade relatives, or partners of the investigator * expected changes in hdm exposure during the study (avoidance measures, move, etc.)

Keywords: non-seasonal allergy house dust mite immunotherapy dose response