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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005187-25-IT

Enrollment

180

Registered

2012-03-19

Start date

2012-05-31

Completion date

Unknown

Last updated

2020-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Trade Name: BUCCALIN*AD 7CPR 0,2G Pharmaceutical Form: Gastro-resistant tablet INN or Proposed INN: ALLERGENS, BACTERIA CAS Number: 8000045-24-1

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: Comparison, vs placebo, during 6 months of the infective episodes of the respiratory tract (number of days of illness) from the day of the first dose. Number of illness days recorded by the patient on a special diary.;Secondary Objective: 1) Assessment of BUCCALIN efficacy vs. placebo, comparing the number of infectious episodes of respiratory tract. 2) Assessment of BUCCALIN vs. placebo on the intensity of the signs and symptoms of infection. 3) Number of cases of patients with more than 1, 2, 3 or 4 acute episodes. 4) Frequency and severity of infection classified by: ear infections, tonsillitis, sinusitis, pharyngotonsillitis, nasopharyngitis and bronchitis, pneumonia. 5) Time of onset of first episode after the end of treatment. 6) Absence from work and work time lost. 7) Global effectiveness according to the investigator, evaluated on a scale of 5 points. 8) Wellness of patients evaluated with VAS after treatment. Safety and Tolerability: 1) Incidence of adverse events. 2) Global tolerability according to the investigator, evaluated on a scale of 4 points.;Primary end point(s): Total duration of infection, expressed in days, along the 6 months after initiation of treatment. One episode will be considered ''new'' if it occurs at least 72 hours after the resolution of the previous episode.;Timepoint(s) of evaluation of this end point: 6 months	—

Measure

Time frame

Main Objective: Comparison, vs placebo, during 6 months of the infective episodes of the respiratory tract (number of days of illness) from the day of the first dose. Number of illness days recorded by the patient on a special diary.;Secondary Objective: 1) Assessment of BUCCALIN efficacy vs. placebo, comparing the number of infectious episodes of respiratory tract. 2) Assessment of BUCCALIN vs. placebo on the intensity of the signs and symptoms of infection. 3) Number of cases of patients with more than 1, 2, 3 or 4 acute episodes. 4) Frequency and severity of infection classified by: ear infections, tonsillitis, sinusitis, pharyngotonsillitis, nasopharyngitis and bronchitis, pneumonia. 5) Time of onset of first episode after the end of treatment. 6) Absence from work and work time lost. 7) Global effectiveness according to the investigator, evaluated on a scale of 5 points. 8) Wellness of patients evaluated with VAS after treatment. Safety and Tolerability: 1) Incidence of adverse events. 2) Global tolerability according to the investigator, evaluated on a scale of 4 points.;Primary end point(s): Total duration of infection, expressed in days, along the 6 months after initiation of treatment. One episode will be considered ''new'' if it occurs at least 72 hours after the resolution of the previous episode.;Timepoint(s) of evaluation of this end point: 6 months

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: 6 months;Secondary end point(s): 1. Evaluation after 6 months of BUCCALIN effect vs. placebo on the reduction of number of infection acute episodes; 2. Number of cases of patients with more than 1, 2, 3 or 4 acute episodes; 3. Frequency and severity, after 6 months, of the infections of the upper and lower respiratory tract; 4. Intensity of the following signs and symptoms: fever, dyspnea, cough, pain, malaise, 5. Onset time (days) of first episode after treatment; 6. Use of other drugs and/or use of clinical care; 7. Day of absence from work at 4 and 6 months; 8. Overall effectiveness evaluated by investigator, after 4 and 6 months, using a 5-score scale; 9. Well-being, assessed by patients by VAS scale, after 6 months. Tolerability secondary end-points: 1) Incidence of adverse events. 2) Global tolerability according to the investigator, evaluated on a scale of 4 points at the end of treatment (visit to the sixth month).	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: 6 months;Secondary end point(s): 1. Evaluation after 6 months of BUCCALIN effect vs. placebo on the reduction of number of infection acute episodes; 2. Number of cases of patients with more than 1, 2, 3 or 4 acute episodes; 3. Frequency and severity, after 6 months, of the infections of the upper and lower respiratory tract; 4. Intensity of the following signs and symptoms: fever, dyspnea, cough, pain, malaise, 5. Onset time (days) of first episode after treatment; 6. Use of other drugs and/or use of clinical care; 7. Day of absence from work at 4 and 6 months; 8. Overall effectiveness evaluated by investigator, after 4 and 6 months, using a 5-score scale; 9. Well-being, assessed by patients by VAS scale, after 6 months. Tolerability secondary end-points: 1) Incidence of adverse events. 2) Global tolerability according to the investigator, evaluated on a scale of 4 points at the end of treatment (visit to the sixth month).

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Countries

Italy

Contacts

Public ContactRicerca Clinica

Medi Service SRL

medi@mediservice.it039 6057074

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026