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 Authorised, recruitment pending · 1 EU/EEA countries · 2 sites · Protocol EXOTIC

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)

Status Authorised, recruitment pending

Participants planned 56

Countries 1

Sites 2

Acute bronchitis

Establish the role of Elixirium thymi compositum (FoNo VIII.) by evaluating its clinical efficacy and safety, meanwhile reducing the inappropriate use of antibiotics in treating acute bronchitis in children.

Key facts

Sponsor: Semmelweis University
Participant type: Pediatric, Patients
Age range: 0-17 years
Gender: Male and Female
Therapeutic area: Diseases [C] - Virus Diseases [C02], Diseases [C] - Respiratory Tract Diseases [C08]
Decision date (initial): 2025-05-07
Transition trial: No
Low-intervention: Yes
Rare-disease indication: No
Vulnerable population: Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

Conditions and MedDRA coding

Acute bronchitis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

Children (6-17 y.o.) with acute bronchitis with BSS score between 5-12

Exclusion criteria 1

Allergy to the product, history of chronic respiratory diseases, heart failure, recent viral diseases, smoking, lung cancer, recent lung/chest surgery, and recent treatments with immunostimulants, antibiotics, steroids, antihistamines or expectorants.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

Efficacy of the investigational product based on the Bronchitis Severity Score

Secondary endpoints 1

Safety and tolerability by the reported adverse events

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Elixirium thymi compositum FoNo VIII. Naturland belsőleges oldat

PRD11244071 · Product

Active substance: Liquid Extract of Thyme (1:3.45-3.85), Extraction Solvent: Ethanol 27VV)
Pharmaceutical form: ORAL SOLUTION
Route of administration: ORAL
Max daily dose: 30 ml millilitre(s)
Max total dose: 150 ml millilitre(s)
Max treatment duration: 5 Day(s)
Authorisation status: Authorised
ATC code: R05CA — EXPECTORANTS
Marketing authorisation: OGYI-TN-73/01
MA holder: NATURLAND MAGYARORSZÁG KFT.
MA country: Hungary
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Placebo 1

Elixirium thymi compositum (fono viii.) placebo

N/A · Product

Other product name: N/A
Pharmaceutical form: N/A
ATC code: N/A — N/A
Marketing authorisation: N/A
MA holder: N/A
MA country: Iceland
Paediatric formulation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Semmelweis University

Sponsor organisation: Semmelweis University
Address: Ulloi Ut 26
City: Budapest VIII
Postcode: 1085
Country: Hungary

Scientific contact point

Organisation: Semmelweis University
Contact name: Dominika Tóth

Public contact point

Organisation: Semmelweis University
Contact name: Dominika Tóth

Locations

1 EU/EEA country · 2 investigational sites

By country

Country	MS status	Planned subjects	Sites
Hungary	Authorised, recruitment pending	56	2
Rest of world	—	0	—

Investigational sites

Hungary

2 sites · Authorised, recruitment pending

Noé Egészségközpont

Noé Egészségközpont, Bárka utca 1., 6721, Szeged