Efficacy and tolerability clinical trial of Lantigen B in the prophylaxis of respiratory infections with reference to patients with allergy to perennial inhalants.

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-003239-76-IT

Enrollment

190

Registered

2011-12-27

Start date

2012-05-07

Completion date

Unknown

Last updated

2013-11-26

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 MedDRA version: 14.1 Level: PT Classification code 10063527 Term: Allergic respiratory symptom System Organ Class: 10038738 - Respiratory, thoracic and mediast

Interventions

Trade Name: LANTIGEN B*OS GTT FL 18ML Pharmaceutical Form: Oral drops, suspension INN or Proposed INN: Estratto antigenico di Streptococcus Pneumoniae tipo 3 Concentration unit: AgU/ml antigen unit(s)

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, 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluation of the efficacy of LANTIGEN B vs. placebo, in reducing, during a 8-month period, the number of infective episodes of the respiratory tract .;Secondary Objective: 1. Days of illness/cycle, following the first treatment; 2. Days of allergic/cycle, following treatment; 3. Number of cases of patients with = 1, = 2, = 3 and = 4 acute episodes; 4. Frequency and severity, of the infective episodes (otitis, tonsillitis, sinusitis, pharyngotonsillitis, and nasopharyngitis) and (bronchitis, pneumonia); 5. Frequency and severity, of allergy (asthma and / or ocular rhinitis), 6. Onset time of first episode after treatment 7. Use of other drugs and/or use of clinical care including drugs for allergy; 8. Day of absence from work time, lost by patients; 9.Overall effectiveness, assessed by means of 5-score scale at the end eight months; 10. Well-being, assessed by patients by VAS scale, after 8 months. Objectives of safety and tolerability: 1 Adverse Event Incidence; 2. Overall tolerability assessed by means of 4-score scale at the end of the eight months.;Primary end point(s): Evaluation of the effects of LANTIGEN B vs. placebo, in reducing, during a 8-month period, the number of infective episodes of the respiratory tract .;Timepoint(s) of evaluation of this end point: 8 months	—

Measure

Time frame

Main Objective: Evaluation of the efficacy of LANTIGEN B vs. placebo, in reducing, during a 8-month period, the number of infective episodes of the respiratory tract .;Secondary Objective: 1. Days of illness/cycle, following the first treatment; 2. Days of allergic/cycle, following treatment; 3. Number of cases of patients with = 1, = 2, = 3 and = 4 acute episodes; 4. Frequency and severity, of the infective episodes (otitis, tonsillitis, sinusitis, pharyngotonsillitis, and nasopharyngitis) and (bronchitis, pneumonia); 5. Frequency and severity, of allergy (asthma and / or ocular rhinitis), 6. Onset time of first episode after treatment 7. Use of other drugs and/or use of clinical care including drugs for allergy; 8. Day of absence from work time, lost by patients; 9.Overall effectiveness, assessed by means of 5-score scale at the end eight months; 10. Well-being, assessed by patients by VAS scale, after 8 months. Objectives of safety and tolerability: 1 Adverse Event Incidence; 2. Overall tolerability assessed by means of 4-score scale at the end of the eight months.;Primary end point(s): Evaluation of the effects of LANTIGEN B vs. placebo, in reducing, during a 8-month period, the number of infective episodes of the respiratory tract .;Timepoint(s) of evaluation of this end point: 8 months

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Secondary

Measure	Time frame
Secondary end point(s): Days of illness following the first treatment day. An infective episode will be considered “new” after 72 hors without clinical symptoms; 2. Days with presence of allergic symptoms after first treatment; 3. Number of cases of patients with = 1, = 2, = 3 and = 4 acute episodes; 4. Frequency and severity, of the infective episodes (otitis, tonsillitis, sinusitis, pharyngotonsillitis, and nasopharyngitis) and (bronchitis, pneumonia); 5. Frequency and severity, of allergy episodes (asthma and / or ocular rhinitis), 6. Onset time (days) of first episode after treatment; 7. Use of other drugs and/or use of clinical care subdivided for therapeutic class; 8. Day of absence from work, time lost by patients; 9. Overall effectiveness evaluated by investigator, at the end eight months, using a 5-score scale; 10. Well-being, assessed by patients by VAS scale, after 8 months. Tolerability endpoints: 1 Adverse Event Incidence; 2. Overall tolerability assessed by investigator by means of 4-score scale at the end of the eight months.;Timepoint(s) of evaluation of this end point: 8 months	—

Measure

Time frame

Secondary end point(s): Days of illness following the first treatment day. An infective episode will be considered “new” after 72 hors without clinical symptoms; 2. Days with presence of allergic symptoms after first treatment; 3. Number of cases of patients with = 1, = 2, = 3 and = 4 acute episodes; 4. Frequency and severity, of the infective episodes (otitis, tonsillitis, sinusitis, pharyngotonsillitis, and nasopharyngitis) and (bronchitis, pneumonia); 5. Frequency and severity, of allergy episodes (asthma and / or ocular rhinitis), 6. Onset time (days) of first episode after treatment; 7. Use of other drugs and/or use of clinical care subdivided for therapeutic class; 8. Day of absence from work, time lost by patients; 9. Overall effectiveness evaluated by investigator, at the end eight months, using a 5-score scale; 10. Well-being, assessed by patients by VAS scale, after 8 months. Tolerability endpoints: 1 Adverse Event Incidence; 2. Overall tolerability assessed by investigator by means of 4-score scale at the end of the eight months.;Timepoint(s) of evaluation of this end point: 8 months

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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