Trial intelligence / Profile preview

Raphamin in the Treatment of Acute Bronchitis in Adults

NCT07650227Phase 3

Key facts

Status: Recruiting
Start: Dec 2025
Primary completion: Dec 2028
Countries: 1
Sponsor: Materia Medica Holding

Drugs: raphamin
Conditions: acute bronchitis

Overview

Phase 3, randomised, double-blind trial in acute bronchitis comparing Raphamin with Placebo (2 arms). Primary endpoint: Proportion of patients with the Bronchitis Severity Scale (BSS) score of 4 points or less at 4 days. Started Dec 2025; status: recruiting.

Design

2 arms

Study design: RandomizedDouble-blind

Raphamin
Patients receive Raphamin tablets for 5 days.
Placebo
Patients receive Placebo tablets matching the Raphamin regimen for 5 days.

Who it enrols

Adult outpatients aged 18-64 with acute bronchitis (symptom duration <72 hours, BSS score 5-15) during the seasonal incidence of ARVI. Excludes patients with chronic pulmonary diseases, suspected pneumonia or bacterial infections, severe heart/kidney/liver failure, immunodeficiency, or severe obesity.

Endpoints

Primary

Proportion of patients with the Bronchitis Severity Scale (BSS) score of 4 points or less4 days

Secondary

Change in the total Bronchitis Severity Scale (BSS) score7 days
Proportion of patients with the BSS score of 4 points or less7 days
Proportion of patients with a decrease in the BSS score by 5 points or more7 days
Change in the severity of acute bronchitis symptoms (cough, sputum, and chest pain)14 days
Proportion of patients with no individual symptoms according to the BSS7 days
Time to effect of therapy according to the IMOS14 days
European Quality of Life Instrument (EQ-5D) total score7 days
Proportion of patients with worsening of bronchitis requiring systemic antibacterial therapy14 days

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