Impact of withdrawal of fusafungine from the market on the prescribing of alternative treatments in Germany (Fusafungine impact study)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  FUSAFUNGINE
• Medical condition to be studied:
  Upper respiratory tract infection

  Upper respiratory tract inflammation

Population studied

• Short description of the study population:
  General Practioners, specialists in internal medicine and other specialist physicians in computerized practices throughout Germany since 1992
• Age groups:
  • Paediatric Population (< 18 years)

    • Neonate

      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  10000

Study design details

• Main study objective:
  To study changes in prescribing of alternative treatments for upper respiratory airways disease after the withdrawal of fusafungine
• Data analysis plan:
  An interrupted time series regression analysis will be used to evaluate statistically the effect of the withdrawal on treatment pathways in patients with selected URAD, comparing the four quarters after the withdrawal with the 12 previous quarters. This will be done using linear regression. Included fusafungine-prescribing practices will be compared to practices with no fusafungine prescribing.