Assessment of the Maximal Tolerated Dose of a Microencapsulated House Dust Mite (Dermatophagoides pteronyssinus and Dermatophagoides farinae) Extract (MHDME) in Subjects with House Dust Mite Allergy in a Randomized, Double-Blind, Placebo-Controlled Study - DME_01

Curalogic A/S0 个研究点目标入组 30 人开始时间: 2007年8月21日最近更新: 2012年3月19日

试验速览

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•- 18 to 65 years old, both inclusive;
•- Have a history of perennial allergic rhinitis;
•- Have a positive skin prick test (SPT) to a standardized HDM (D. pteronyssinus and D. farinae) extract performed within the last six months before screening, which is defined as:
•Diameter of the weal of at least the size of the positive control (histamine-
•dihydrochloride) and
•Diameter of the weal of at least 3 mm for each of the HDM (D. pteronyssinus or
•D. farinae) species;
•- Have an allergen-specific IgE to HDM (D. pteronyssinus and D. farinae) with a concentration of at least 0.7 kU/L using the Phadia ImmunoCAP assay (Freiburg, Germany); the test should be performed within the last six months;
•- Have a positive reaction to a nasal challenge or to an eye challenge with HDM (D. pteronyssinus) extract; the test should be performed within the last six months.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Have a severe autoimmune disease or a severe immunodeficiency;
•- Are currently receiving immunotherapy to any allergens or have received HDM immunotherapy within three years before the Screening Visit (immunotherapy to other allergens than HDM discontinued within 90 days before the Screening Visit is allowed);
•- Have moderate to severe persistent asthma (Global Initiative for Asthma, GINA, criteria III and IV);
•- Have insufficiently treated asthma and/or irreversible airway obstruction with a value of forced expiratory volume (FEV1) <70% of predicted (mean out of three acceptable values) despite of asthma medication
•- Use prohibited medications or have inadequate washout periods before the start of the study. The following medications are prohibited during the study and if taken before the study, the required wash-out periods are indicated in brackets:
•Oral corticosteroids (one month);
•Leukotriene (seven days);
•Antihistamines:
•o H1-blocker (three days),
•Anti-lgE medication (six months),
•Tricyclic antidepressants (14 days);
•Use of beta-receptor antagonists (oral, topical) before the study and need to
•use them during the study.
•- History of hypersensitivity to the IMP or its excipients (subjects enrolled in this study are expected to be allergic to HDM). Hypersensitivity to the IMP means that the subject has had a previous generalized or severe local reaction to HDM extract previously used for SPT or immunotherapy.

发起方

Curalogic A/S