Ambroxol for the treatment of children with acute and chronic respiratory diseases: an overview of efficacy and safety

  • Ahmad Kantar Pediatric Cough and Asthma Center, Istituti Ospedalieri Bergamaschi, University and Research Hospitals, Bergamo, Italy.
  • Ludger Klimek Wiesbaden Center for Rhinology and Allergology, Wiesbaden, Germany.
  • Dorotheea Cazan Maria Hilf Kliniken, Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Aachen, Mönchengladbach, Germany.
  • Annette Sperl Wiesbaden Center for Rhinology and Allergology, Wiesbaden, Germany.
  • Ulrike Sent Medical Advisor CHC GSA, Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany.
  • Margarida Mesquita | margarida.mesquita@sanofi.com Global Medical Lead CHC, Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany.

Abstract

Ambroxol (2-amino-3,5-dibromo-N-[trans-4-hydroxycyclohexyl]benzylamine), an over-thecounter product, is a mucoactive agent and has been used widely to treat both acute and chronic respiratory diseases since 1978. This review aims to provide an overview of the clinical evidence available on the use of ambroxol in children with acute and chronic respiratory diseases. Data for this review were obtained from both published and unpublished clinical studies, and real-world evidence studies. Although conducted prior to the introduction of Good Clinical Practice (GCP), these studies, representing almost 1,300 pediatric patients, report strong clinical outcomes following the use of ambroxol in pediatric patients. Furthermore, efficacy findings were consistent irrespective of age, including for patients as young as 1 month old. Additionally, the majority of studies found ambroxol to be well tolerated in children. Taken together, the clinical evidence for ambroxol shows treatmenteffects that offer significant benefits to pediatric patients for its licensed use as a secretolytic therapy in acute and chronic bronchopulmonary disorders associated with abnormal mucus secretion and impaired mucus transport. The findings from this review indicate that ambroxol, for its intended over-the-counter indications, is both efficacious and well tolerated in children and that the favorable benefit/risk profile of ambroxol reported in adults extends to the pediatric population, starting from early infancy, with acute and chronic respiratory diseases.

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Published
2020-03-03
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Issue
Section
Reviews
Keywords:
ambroxol, children, respiratory diseases, mucoactive, over-the-counter drugs
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How to Cite
Kantar, A., Klimek, L., Cazan, D., Sperl, A., Sent, U., & Mesquita, M. (2020). Ambroxol for the treatment of children with acute and chronic respiratory diseases: an overview of efficacy and safety. Multidisciplinary Respiratory Medicine, 15. https://doi.org/10.4081/mrm.2020.511