Efficacy and tolerability clinical trial of Lantigen B (A bacterial lysate having immunostimulating activity) in the prophylaxis of respiratory infections, with special reference to patients with allergy to perennial inhalants. Double-blind multicenter, randomized study vs. placebo. - LAN-BR-11-001

BRUSCHETTINI SR0 个研究点目标入组 190 人开始时间: 2011年12月27日最近更新: 2013年11月26日

试验速览

暂无简介。

•1. Patients of both sexes, aged between 18 and 65 years, who have suffered, during the previous year, from 2 to 6 episodes of bacterial infections of the upper respiratory tract, possibly associated with episodes of respiratory allergy; 2. Absence of malformations and /or active clinically significant disease; 3. Patients able to understand and follow the requirements specified by investigator and in study protocol.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 190
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Episodes of acute infectious or non-infectious in progress at randomization, requiring hospitalization and / or intensive care, 2. Gastroesophageal reflux; 3. Carrier of autoimmune diseases; 4. Patients assuming, in the two weeks prior the recruitment, any products belonging to ATC J06 group (immune sera and immunoglobulins) or J07AX group; 5. Treatment in the two weeks prior the recruitment or need to treat along the study period with immunostimulants belonging to J07AX ATC group; antineoplastic belonging to the ATC L01 group; drugs belonging to the groups L03 and L04 ATC as cytokines, interleukins, interferon, immunosuppressants, systemic corticosteroids; 6. History of allergy or intolerance to the investigational product and / or excipients; 7. Patients unable, for linguistic or psychological reasons, to understand the information given to obtain informed consent or who refuse to sign consent; 8. Partecipation to another clinical study in the previous month or during this study; 9. Pregnant or lactating women.

发起方

BRUSCHETTINI SR