A Phase 4 interventional study of Elixirium thymi compositum (FoNo VIII.) and Elixirium thymi compositum (FoNo VIII.) placebo in Acute Bronchitis, sponsored by Semmelweis University. Enrolling by invitation at 1 site in Hungary. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2025-06-26.
Sponsored by Semmelweis University · Phase 4, Interventional, and Treatment
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?
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.
Exclusion Criteria:
For 6-9 years old patients, 6 ml oral solution three times a day for 5 days. For 9-15 years old patients, 8 ml oral solution three times a day for 5 days. For 15-17 years old patients, 10 ml oral solution three times a day for 5 days.
Combination Product: Elixirium thymi compositum (FoNo VIII.)
A placebo identical in appearance (color) and taste to the investigational product, without the active ingredient (thyme tincture). For 6-9 years old patients, 6 ml oral solution three times a day for 5 days. For 9-15 years old patients, 8 ml oral solution three times a day for 5 days. For 15-17 years old patients, 10 ml oral solution three times a day for 5 days.
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.
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.
Bronchitis Severity Score
The Bronchitis Severity Scale (BSS) is a tool that assesses the five most important symptoms of acute bronchitis: cough, sputum production, wheezing, chest pain on coughing, and dyspnea. The assessment is based on the examiner's clinical judgment and patient feedback. The examiner rates each parameter of the BSS on a 5-point verbal scale from 0 to 4 (0: absent; 1: mild; 2: moderate; 3: severe; 4: very severe). The total BSS score is the sum of the ratings of the five symptoms, with a maximum score of 20.
Time frame: From enrollment to the end of study at 7 days, measured on Day 0, Day 3 and Day 7.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Any adverse events and concomitant medications during the 7-day period.
Time frame: From enrollment to the end of study at 7 days.
Quality of life in acute bronchitis
Quality of life in patients with acute bronchitis was assessed using the Quality of Life Questionnaire, which measures the physical, psychological, and social impact of symptoms during illness. Each question is scored from 1 (absent symptom) to 5 (very severe symptom). Domain scores are calculated as the average of item scores within each domain (Physical: 6 items, Psychological: 7 items, Social: 5 items), resulting in a range of 1 to 5 per domain. The total score, obtained by summing the three domain scores, ranges from 3 (best possible quality of life) to 15 (worst possible quality of life).
Time frame: From enrollment to the end of study at 7 days.
Plan to share: No — There is not a plan to make individual participant data (IPD) available for this study. The informed consent form, in compliance with the EU General Data Protection Regulation (GDPR) and relevant Hungarian laws, specifically informs participants that their data will be handled confidentially, stored anonymously, and presented only in aggregate, anonymized form in any resulting publications. The consent does not include permission for broader sharing of individual-level data outside the study team or approved data processors.
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Semmelweis University