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

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?

Timeline

Start

2025-07

Primary completion

2027-06

Completion

2027-12

Publications

• Background Saust LT, Bjerrum L, Siersma V, Arpi M, Hansen MP. Quality assessment in general practice: diagnosis and antibiotic treatment of acute respiratory tract infections. Scand J Prim Health Care. 2018 Dec;36(4):372-379. doi: 10.1080/02813432.2018.1523996. Epub 2018 Oct 8.
• Background Braman SS. Chronic cough due to acute bronchitis: ACCP evidence-based clinical practice guidelines. Chest. 2006 Jan;129(1 Suppl):95S-103S. doi: 10.1378/chest.129.1_suppl.95S.
• Background Cutrera R, Baraldi E, Indinnimeo L, Miraglia Del Giudice M, Piacentini G, Scaglione F, Ullmann N, Moschino L, Galdo F, Duse M. Management of acute respiratory diseases in the pediatric population: the role of oral corticosteroids. Ital J Pediatr. 2017 Mar 23;43(1):31. doi: 10.1186/s13052-017-0348-x.
• Background Gonzales R, Sande MA. Uncomplicated acute bronchitis. Ann Intern Med. 2000 Dec 19;133(12):981-91. doi: 10.7326/0003-4819-133-12-200012190-00014.
• Background Snyder RL, King LM, Hersh AL, Fleming-Dutra KE. Unnecessary antibiotic prescribing in pediatric ambulatory care visits for bronchitis and bronchiolitis in the United States, 2006-2015. Infect Control Hosp Epidemiol. 2021 May;42(5):612-615. doi: 10.1017/ice.2020.1231. Epub 2020 Oct 16.
• Background Wenzel RP, Fowler AA 3rd. Clinical practice. Acute bronchitis. N Engl J Med. 2006 Nov 16;355(20):2125-30. doi: 10.1056/NEJMcp061493. No abstract available.
• Background Gonzales R, Bartlett JG, Besser RE, Cooper RJ, Hickner JM, Hoffman JR, Sande MA; Centers for Disease Control and Prevention. Principles of appropriate antibiotic use for treatment of uncomplicated acute bronchitis: background. Ann Emerg Med. 2001 Jun;37(6):720-7. doi: 10.1067/S0196-0644(01)70091-1.
• Background Kowalczyk A, Przychodna M, Sopata S, Bodalska A, Fecka I. Thymol and Thyme Essential Oil-New Insights into Selected Therapeutic Applications. Molecules. 2020 Sep 9;25(18):4125. doi: 10.3390/molecules25184125.
• Background Ludwig S, Stier H, Weykam S. Evaluation of Blood Alcohol Concentrations after Oral Administration of a Fixed Combination of Thyme Herb and Primrose Root Fluid Extract to Children with Acute Bronchitis. Drug Res (Stuttg). 2016 Feb;66(2):69-73. doi: 10.1055/s-0034-1398543. Epub 2015 Feb 17.
• Background Kamin W, Maydannik VG, Malek FA, Kieser M. Efficacy and tolerability of EPs 7630 in patients (aged 6-18 years old) with acute bronchitis. Acta Paediatr. 2010 Apr;99(4):537-43. doi: 10.1111/j.1651-2227.2009.01656.x. Epub 2010 Jan 11.
• Background Gruenwald J, Graubaum HJ, Busch R. Evaluation of the non-inferiority of a fixed combination of thyme fluid- and primrose root extract in comparison to a fixed combination of thyme fluid extract and primrose root tincture in patients with acute bronchitis. A single-blind, randomized, bi-centric clinical trial. Arzneimittelforschung. 2006;56(8):574-81. doi: 10.1055/s-0031-1296754.
• Background Kardos P, Bittner CB, Seibel J, Abramov-Sommariva D, Birring SS. Effectiveness and tolerability of the thyme/ivy herbal fluid extract BNO 1200 for the treatment of acute cough: an observational pharmacy-based study. Curr Med Res Opin. 2021 Oct;37(10):1837-1844. doi: 10.1080/03007995.2021.1960493. Epub 2021 Aug 13.
• Background Kemmerich B, Eberhardt R, Stammer H. Efficacy and tolerability of a fluid extract combination of thyme herb and ivy leaves and matched placebo in adults suffering from acute bronchitis with productive cough. A prospective, double-blind, placebo-controlled clinical trial. Arzneimittelforschung. 2006;56(9):652-60. doi: 10.1055/s-0031-1296767.
• Background Haidvogl M, Heger M. Treatment effect and safety of EPs 7630-solution in acute bronchitis in childhood: report of a multicentre observational study. Phytomedicine. 2007;14 Suppl 6:60-4. doi: 10.1016/j.phymed.2006.11.014. Epub 2006 Dec 20.
• Background Matthys H, Kamin W, Funk P, Heger M. Pelargonium sidoides preparation (EPs 7630) in the treatment of acute bronchitis in adults and children. Phytomedicine. 2007;14 Suppl 6:69-73. doi: 10.1016/j.phymed.2006.11.015. Epub 2006 Dec 20.
• Gergo D, Garmaa G, Harsfalvi P, Wenning AS, Teutsch B, Hegyi P, Bella Z, Roman R, Vanyolos A, Csupor D. Elixirium Thymi Compositum in the Treatment of Acute Bronchitis in Pediatric Patients (EXOTIC): Protocol of a Randomized, Double-Blind Clinical Trial. Pediatr Pulmonol. 2026 Mar;61(3):e71544. doi: 10.1002/ppul.71544.

Drugs

Indications