Evaluating the efficacy, safety, tolerability of use and treatment adherence in two different dosing schedules, pre-costagionale and costagionale, of a sublingual allergoid (Lais Parietaria)administered to patients suffered from oculorhinitis with or without bronchial asthma by Parietaria. Randomized double-blind, multicenter, parallel group, placebo-controlled. - ParLais/09

OFARMA0 个研究点开始时间: 2009年3月10日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•1. Aged between 18 and 60 years, male and female. 2. Clinical history of rhinitis (oculorhinitis) intermittent mild to persistent moderate/severe asthma with or without intermittent allergic grade by at least 2 years. 3. Presence of symptoms only during the pollen season Parietaria. 4. Awareness Parietaria confirmed by skin test (skin prick) positive for Parietaria with hives with an average diameter of 3 mm higher than the negative control hives. 5. Subjects with sufficient degree of cooperation and understanding that have agreed to study and provided informed consent signed for confirmation.
•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

•1. Sensitisation to other allergens with possible overlap of pollen such as: Grasses, Cypress, Birch
•2. Bronchial asthma or severe persistent with FEV1 <80% of theoretical value
•3. Sensitisation to cat or dog if the animal is present in your home
•4. Systemic immunological diseases congenital or acquired immunodeficiencies
•5. Diabetes, severe heart disease, neoplastic diseases actually or previous
•6. Diseases that require chronic treatment with corticosteroids, immunosuppressants or beta -
•7. Neurological-psychiatric diseases (requiring psychotropic drugs more)
•8. Ongoing pregnancy or lactation
•9. Parietaria specific immunotherapy for the last 5 years

发起方

OFARMA