Broncalt®, class II medical device, in patients with chronic relapsed upper airways disease: a survey in clinical practice

Acta Biomed. 2019 Jul 10;90(7-S):36-40. doi: 10.23750/abm.v90i7-S.8656.

Abstract

Inflammation and infection are common pathogenic mechanisms involved in many otorhinolaryngological (ORL) chronic diseases. Broncalt® is a class II Medical Device containing: thermal water (Medesano, PR, Italy), hyaluronic acid, and grapefruit seed extract. It could exert a safe and effective anti-inflammatory, washing, and antimicrobial activity by virtue of these components. Therefore, the aim of the current survey, conducted in clinical practice of 84 Italian ORL centers, was to evaluate its safety and efficacy in the treatment of patients with chronic upper airways disease. The 1,817 (958 males, mean age 49 years) patients were evaluated at baseline (T0) and after one (T1) and two (T2) weeks of treatment, they were treated or not treated with Broncalt®. Signs and symptoms severity were measured by visual analogue scale. Broncalt® significantly, quickly, and safely diminished the clinical features in all sub-groups (p<0.001 for all). In conclusion, Broncalt® is a class II Medical Device able to exert a safe, quick, and effective activity in patients with chronic ORL disorders.

Publication types

  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Chronic Disease
  • Citrus paradisi
  • Equipment and Supplies / adverse effects
  • Equipment and Supplies / classification
  • Female
  • Health Care Surveys
  • Humans
  • Hyaluronic Acid / administration & dosage
  • Male
  • Middle Aged
  • Otolaryngology / instrumentation
  • Otorhinolaryngologic Diseases / therapy*
  • Plant Extracts / administration & dosage
  • Recurrence
  • Seeds
  • Treatment Outcome
  • Water / administration & dosage

Substances

  • Plant Extracts
  • Water
  • Hyaluronic Acid