Efficacy and tolerability clinical trial of an immunostimulant made from inactivated bacteria (BUCCALIN) in the prophylaxis of infection of the airways (rhinotracheobronchitis, colds). Double-blind multicenter, randomized study vs. placebo. - BUC-SI-11-001

SOCIETA' LABORATORIO FARMACEUTICO S.I.T. SR0 个研究点目标入组 180 人开始时间: 2012年3月19日最近更新: 2020年2月1日

适应症

试验速览

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•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; 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 180
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1) During acute episodes (infectious and noninfectious) at randomization, at the expense of any equipment, requiring hospitalization and / or intensive care. 2) Gastroesophageal reflux 3) Carriers of autoimmune diseases. 4) Treatment with any of the products belonging to ATC gruop J06 (immune sera and immunoglobulins) or J07AX (immunostimulant) taken in the two weeks prior to recruitment. 5) Treatment in the two weeks prior to recruitment or suppository treatment needs for the entire duration of the study, including the period of follow-up with: ATC group J07AX (immunostimulants); ATC group L01 antineoplastic; drugs belonging to the ATC groups L03 and L04 as cytokines, interleukins, interferon, immunosuppressant; systemic corticosteroids. 6) History of allergy or intolerance to the investigational product and / or excipients. 7) Patients unable to linguistic or psychological reasons, to understand the information given to obtain the consent or refuse to give consent in writing. 8) Another clinical study in the previous month or during this study. 9) Women who are pregnant or breastfeeding.

发起方

SOCIETA' LABORATORIO FARMACEUTICO S.I.T. SR