REDS (REspiratory Drugs Survey) STUDY. Active surveillance of respiratory drugs, especially Inhaled Steroids (IS) in children (REDS STUDY)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Case-control

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (R01A) DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE

  DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
• Medical condition to be studied:
  Childhood asthma

Population studied

• Short description of the study population:
  Children of both sexes, aged between 0 and 14 years suffering from illnesses (asthma, etc.) who were foreseen to be using respiratory medication and in particular the IS in compliance with the Guidelines.
• Age groups:
  • Term newborn infants (0 – 27 days)
  • Infants and toddlers (28 days – 23 months)
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)
• Estimated number of subjects:
  3000

Study design details

• Main study objective:
  The primary objective of the study is monitoring the use of respiratory medication and in particular the IS with careful analysis of the risk / benefit factor of the therapy (for possible ADRs) in the age group from 0 to 14 years, through: 1) Accuracy of diagnosis,2) Therapeutic Appropriateness,3) Safe use of medication,4) Correct follow-up
• Outcomes:
  - Evaluate the effectiveness of the therapy in the acute phase according to the GL. - Reduce the number of pharmaceutical respiratory prescriptions (especially IS) - Check and give a correct estimate of possible ADRs associated with this type of medication administered by Family Pediatricians - Increase the number of reported ADRs - Decrease the "do it yourself" by parents
• Data analysis plan:
  The data of prevalence of prescriptions of IS iN children and any ADRs related to the use of IS will be highlighted. Safety usage- calculating the impact of ADRs in the population at risk taking part in the research, until the risk assessment of some ADRs are compared and associated with specific pharmaceuticals within groups. The univariate statistical analysis and description of the characteristics of the sample will produce frequencies, medians and interquartile range for variable nonparametric and medium ± standard deviation for parametric variables. The confidence intermissions at 95% will be calculated where possible. The bivariate analysis for variable categorical will be produced using the two-tailed χ2 test and when appropriate, the Fisher corrector will be used, for numeric variables, any differences in averages between groups will be assessed by the student's t-test. Statist. significance is defined by a value of P <0.05 and will be calculated at 95% C.I-R version2.13.0