NCT05588804

Study of the Efficacy and Safety of Broncho-munal®, Capsules, 7 mg for the Treatment of Acute Uncomplicated Respiratory Tract Infections

A Randomized Double-blind Placebo-controlled Comparative Multicenter Study of the Efficacy and Safety of Broncho-munal®, Capsules, 7 mg (Sandoz dd, Slovenia) in the Treatment of Patients With Acute Uncomplicated Respiratory Tract Infections

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 556 (actual)
• Sponsor: Sandoz · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The study will evaluate the efficacy and safety of Broncho-munal®, capsules, 7 mg (Sandoz dd, Slovenia) versus Placebo in the treatment of patients with acute uncomplicated respiratory tract infections.

Detailed description

Patients who meet the inclusion criteria and do not meet the exclusion criteria will be randomized into 2 groups in a 1: 1 ratio. Group 1 (n = 278) will receive the study drug Broncho-munal®, capsules, 7 mg (Sandoz dd, Slovenia), Group 2 (n = 278) will receive a placebo

Conditions

• Acute Uncomplicated Respiratory Tract Infections

Interventions

Type	Name	Description
DRUG	Broncho-munal®	1 capsule daily in the morning on an empty stomach, 30 minutes before meals, for 10 consecutive days
DRUG	Placebo	1 capsule daily in the morning on an empty stomach, 30 minutes before meals, for 10 consecutive days

Timeline

• Start date: 2022-11-07
• Primary completion: 2022-12-18
• Completion: 2022-12-18
• First posted: 2022-10-20
• Last updated: 2023-08-04

Locations

13 sites across 1 country: Russia