Trial intelligence / Profile preview

Buccalin in the prophylaxis of recurrent lower respiratory tract infections

NCT06736288Phase 4

Key facts

Status
Recruiting
Start
Oct 2025
Primary completion
Apr 2027
Countries
2
Modality
Vaccines & Immunotherapeutics
Conditions
lower respiratory tract infection (LRTI)
01

Overview

Phase 4, randomised, double-blind trial in lower respiratory tract infection (LRTI) comparing Buccalin with Placebo (2 arms). Primary endpoint: Reduction in the number of infection episodes at 12 months. Started Oct 2025; status: recruiting.

02

Design

2 arms
Study design
RandomizedDouble-blind
  • Buccalin

    Active treatment with bacterial lysate tablets.

  • Placebo

    Placebo comparator.

03

Who it enrols

Adults with recurrent lower respiratory tract infections (>=2 episodes in previous 12 months and >=2 during run-in) excluding those with pneumonia, TB, cystic fibrosis, or immunodeficiency.

04

Endpoints

Primary

  • Reduction in the number of infection episodes

Secondary

  • Safety of Buccalin

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