NCT06736288 - Post Authorization Efficacy and Safety Study (PAES) to Confirm and Collect More Clinical Data of Buccalin® Tablets in the Prophylaxis of Recurrent Lower Respiratory Tract Infections (RLRTIs). | Biotech Hunter

Enrollment

240

Participants

Timeline

Start Date

January 31, 2025

Primary Completion Date

January 31, 2027

Study Completion Date

June 30, 2028

Conditions

Respiratory InfectionLower Respiratory Tract Infection (LRTI)

Interventions

DRUG

BUCCALIN®

"Gastro-resistant tablets (mixture of Streptococcus pneumoniae I, II, III, Streptococcus agalactiae, Staphylococcus aureus, Haemophilus influenzae).~The recommended dosage is 1 tablet on day 1, 2 tablets on day 2, and 4 tablets on day 3 and should be taken in the morning on an empty stomach."

OTHER

Placebo

Gastro-resistant tablets containing only excipients). The recommended dosage is 1 tablet on day 1, 2 tablets on day 2, and 4 tablets on day 3 and should be taken in the morning on an empty stomach.