Increasing ICS Dose vs Add-on Therapy in Children with Asthma (Paediatric Asthma Step-up)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (H02) CORTICOSTEROIDS FOR SYSTEMIC USE

  CORTICOSTEROIDS FOR SYSTEMIC USE

  (R03DC) Leukotriene receptor antagonists

  Leukotriene receptor antagonists

  (R03) DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

  DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
• Medical condition to be studied:
  Asthma

Population studied

• Short description of the study population:
  Asthma patients on inhaled corticosteroid therapy (any ICS) between January 1990 and the end of December 2010 (2011).
• Age groups:
  • Paediatric Population (< 18 years)

    • Children (2 to < 12 years)
• Special population of interest:
  Other
• Special population of interest, other:
  Asthma patients
• Estimated number of subjects:
  17000

Study design details

• Main study objective:
  The primary focus is to investigate the relationship between a step-up in asthma treatment (i.e. addition of a long-acting β-agonist (LABA), leukotriene receptor antagonist (LTRA) or increased ICS dose) in children aged 5-12 and the impact on asthma control over a 12 month period.
• Outcomes:
  Exacerbation Rate (ATS/ERS Definition) Where an exacerbation is defined as the occurrence of: (i) Asthma-related1: a. Hospital attendance / admissions OR b. A&E attendance (ii) Use of acute oral steroids2, Database Asthma Control, defined as:the absence of the following during the one-year outcome period:(i) Asthma-related: Hospital admission, A&E attendance, Out of hours attendance, Out-patient department attendance (ii) GP consultations for lower respiratory tract infection(iii) Prescriptions for acute courses Additional secondary measures:Hospitalisations, Adherence,SABA usage
• Data analysis plan:
  Patients will be characterised over a 1-year baseline period. For outcome evaluation, patients will be matched on on key clinical and demographic features to minimise differences between treatment arms and to minimise the risk of confounders. Remaining differences will be adjusted for using suitable statistical modelling.Both unmatched and matched results will be reported, as well as matched results adjusted and unadjusted for residual confounders.