IgE-mediated allergic disorders
Conditions
Interventions
Product Name: SUBLIVAC
Pharmaceutical Form: Oromucosal drops
Sponsors
HAL Allergy BV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ·Subject selected to be treated with SLIT. ·Male or female, age ³ 8 years. ·Subject with rhinitis or rhinoconjunctivitis ·The allergy should be confirmed by, for example, a positive SPT (mean wheal diameter > 3 mm) or specific serum IgE-test (RAST = 2). ·Subject must be willing to follow all study procedures including attendance at practise for scheduled study visits and compliance with study treatment regimen. ·Subject must give a written informed consent (IC). Are the trial subjects under 18? yes 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ·Chronic asthma or emphysema, particularly with a FEV1 < 70% of predicted value. ·Serious immunopathologic diseases or malignancies (including auto-immune diseases, tuberculosis). ·Symptomatic coronary heart diseases or severe (even under treatment) arterial hypertension. ·Diseases with a contra-indication for the use of adrenaline. ·Severe kidney disease. ·Use of systemic steroids. ·Treatment with ß-blockers or ACE inhibitors or immunosuppressive drugs. ·Active infection of the target organ. ·Severe atopic dermatitis. ·Participation in a clinical study with a new investigational drug within 3 months prior to enrolment. ·Pregnancy, lactation or inadequate contraceptive measures. ·Alcohol- or drug abuse. ·Lack of co-operation or severe psychological disorders. ·Other serious or unstable medical or psychological condition that, in the opinion of the investigator, would compromise the subject’s safety or successful participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the study is to show that a rush-in initial phase of 5 days with SUBLIVAC® is as safe as a conventional initial phase of 15 days.;Secondary Objective: ;Primary end point(s): The percentage of subjects reaching the maintenance dose according the rush regime compared to the conventional regimen. | — |
Countries
Germany
Outcome results
None listed