NCT07030855

Efficacy of Elixirium Thymi Compositum in the Treatment of Acute Bronchitis in Pediatric Patients

Assessing the Efficacy of Elixirium Thymi Compositum in the Treatment of Acute Bronchitis in Pediatric Patients (EXOTIC): A Double-blind, Randomized, Placebo-controlled, Phase 4 Study

• Status: Enrolling By Invitation
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Semmelweis University · Academic / Other
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the efficacy and safety of Elixirium thymi compositum (Formulae Normales (FoNo) VIII.) compared to a placebo in children between 6 and 17 years old to treat their acute bronchitis. The main question it aims to answer is: Is Elixirium thymi compositum (FoNo VIII.) safe and effective in the treatment of acute bronchitis compared to placebo?

Detailed description

Acute bronchitis is a common disease caused mainly by viral infections. Although there is a standard symptomatic therapy for it, antibiotics are often prescribed, which contributes to an increase in antibiotic resistance. Elixirium thymi compositum (FoNo VIII.) might be an alternative therapeutic option. The aim is to establish the role of this product by evaluating its clinical efficacy and safety, meanwhile reducing the misuse of antibiotics in treating this condition. This is a randomized, controlled, double-blinded, two-arm multicenter phase 4 trial. Eligible patients will be pediatric individuals between 6 and 17 years old diagnosed with acute bronchitis. The trial will enroll at least 56 eligible participants with a Total Bronchitis Severity Score (BSS) ranging from 5 to 12 points. Participants will be assigned randomly in a 1:1 ratio to receive either Elixirium thymi compositum at an age-dependent dosage (18-30 ml daily) for 5 days or a placebo with the same concentration and duration. The trial's primary endpoint is the assessment of symptom improvement in acute bronchitis, as indicated by changes in the BSS score on Day 7. Secondary endpoints include evaluating use of concomitant medications and dietary supplements, safety and tolerability through reported adverse events, and the necessity of antibiotic usage. These secondary endpoints will provide deeper insights into the differences between the treatment and placebo groups. The primary and secondary endpoints will be monitored throughout a follow-up period of 7 days.

Conditions

• Acute Bronchitis

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Elixirium thymi compositum (FoNo VIII.)	During the study, the dosage is for children and adolescents as follows: 6 ml three times a day for 6-9 years, 8 ml three times a day for 9-15 years, and 10 ml three times a day for 15-17 years.
COMBINATION_PRODUCT	Elixirium thymi compositum (FoNo VIII.) placebo	During the study, the dosage is for children and adolescents as follows: 6 ml three times a day for 6-9 years, 8 ml three times a day for 9-15 years, and 10 ml three times a day for 15-17 years.

Timeline

• Start date: 2025-07-01
• Primary completion: 2027-06-01
• Completion: 2027-12-01
• First posted: 2025-06-22
• Last updated: 2025-06-26

Locations

1 site across 1 country: Hungary