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

Conditions: Episodes classified by upper respiratory infections (otitis, tonsillitis, sinusitis, pharyngotonsillitis, nasopharyngitis) and lower respiratory tract (bronchitis, pneumonia).
MedDRA version: 14.1Level: PTClassification code 10060693Term: Respiratory tract infection bacterialSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.1Level: PTClassification code 10063527Term: Allergic respiratory symptomSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2011-003239-76-IT

Lead Sponsor: BRUSCHETTINI SR

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 190

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

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.