ASSESSMENT OF THE EFFICACY OF THE HEDUSSIN® MEDICINAL PRODUCT USE IN THE TREATMENT OF PRODUCTIVE (WET) COUGH

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Post Authorization Efficiency Study (PAES)

Population studied

• Short description of the study population:
  Patient of either sex, aged 2 to 12 with diagnosis of a productive (wet) cough of various aetiology who were recommented to use HEDUSSIN® were included during 1st visit
• Age groups:
  • Children (2 to < 12 years)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with productive (wet) cough
• Estimated number of subjects:
  500

Study design details

• Main study objective:
  Primary objective was efficacy of treatment with authorized medical product HEDUSSIN® in the therapy of productive cough in the course of respiratory tract infection in daily clinical practice (real life).
• Outcomes:
  Secondary objective was assessment of medical product HEDUSSIN® safety in the therapy of respiratory tract infection in daily clinical practice (real life).
• Data analysis plan:
  The sample size of 500 Patients was based on the feasibility study. The analysis of the data obtained in the Study will be descriptive: the compiled data will consist of summarizing statistics such as quantities, average values, standard deviations, medians, minimal and maximal values of the observed frequencies/proportions. The effectiveness analysis will be conducted on the basis of the population of Patients who will partake in all of the visits described in the Study Protocol.