Efficacy and tolerability clinical trial of BUCCALIN in the prophylaxis of respiratory infections.

Phase 1

• Conditions: Episodes classified by upper respiratory infections (otitis, tonsillitis, sinusitis, pharyngotonsillitis, nasopharyngitis) and lower respiratory tract (bronchitis, pneumonia).; MedDRA version: 14.1 Level: PT Classification code 10060693 Term: Respiratory tract infection bacterial System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2011-005187-25-IT
• Lead Sponsor: SOCIETA' LABORATORIO FARMACEUTICO S.I.T. SR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-03-19
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 180

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified