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

Phase 4Enrolling By InvitationNCT07030855

Semmelweis University56 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Acute Bronchitis

Interventions

Elixirium thymi compositum (FoNo VIII.)COMBINATION_PRODUCT

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.

Elixirium thymi compositum (FoNo VIII.) placeboCOMBINATION_PRODUCT

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.

Eligibility

Sex: ALLMin age: 6 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. age 6-17 years, 2. diagnosis of acute bronchitis and the Total Bronchitis Severity Score of the patient is between 5-12 points, 3. informed consent form and patient information leaflet signed by the patient and the parent or legal guardian, and 4. no pregnancy, no planned pregnancy, and no breastfeeding. Exclusion Criteria: 1. allergy to the active ingredients or any other components of Elixirium thymi compositum, 2. hypersensitivity to plants of the Lamiaceae family, 3. chronic respiratory diseases such as asthma, chronic bronchitis, and chronic obstructive pulmonary disease, 4. pneumonia in the last year, 5. a history of recurrent or severe laryngotracheal stenosis due to inflammation,. 6. active or chronic inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis) or infectious enterocolitis, 7. heart failure (New York Heart Association Class II-IV), 8. smoking (the patient currently smokes or has smoked at least one cigarette, cigar, or pipe daily), 9. a diagnosis or history of lung cancer, 10. a history of lung or chest surgery, 11. epilepsy, 12. any viral infection in the last 6-8 weeks, 13. immunostimulant medications, antibiotics, or systemic steroid treatments in the past month, 14. antihistamines, expectorants, or local steroids applied in the last two weeks, 15. hereditary fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency, 16. taking or planning to take hormonal contraceptives within the next 2 weeks 17. chronic liver disease (e.g., cirrhosis) or acute hepatitis.

Locations (1)

Noé Medical Center

Szeged, Hungary

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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