Observational study to quantify in real life the contribution of SINGULAIR ® 4mg in children aged from 6 to 24 months (NA)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• 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

• Name of medicine, other:
  Singulair
• Medical condition to be studied:
  Asthma

Population studied

• Short description of the study population:
  Children under 2 years old with mild to moderate persistent asthma, poorly controlled when real prescribing practice.
• Age groups:
  Infants and toddlers (28 days – 23 months)
• Special population of interest:
  Other
• Special population of interest, other:
  Asthma patients
• Estimated number of subjects:
  115500

Study design details

• Main study objective:
  The objective was to assess the characteristics, medical management, andMedical Resources Utilization of recurrent wheezing infants identified from national claims data.
• Outcomes:
  Number of exacerbations during follow-up periodTime to the 1st exacerbation, number of visits to GPnumber of visits to pneumologistother MRU associated to asthmanumber of dispensations of antibioticsnumber of dispensations other dispensations
• Data analysis plan:
  1. Descriptive analysis of quantitative and ordinal variables (number and frequency of each therapeutic scheme, with 95% IC).Descriptive analysis of qualitative variables (average, standard deviation, median, percentiles and lower and higher limits). Outliers identified by boxplots.2. Comparative analysis after matching (infants under Singulair vs. infants under IC)

Documents

Study publications

Belhassen M, de Pouvourville G, Laforest L, Brouard J, de Blic J, Fauroux B, La…