Modified Prescription-Event Monitoring Study to Monitor the Introduction of Atrovent Inhaler CFC-Free® MDI in the United Kingdom (Atrovent CFC-free M-PEM)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Prescription event monitoring

Study drug and medical condition

• Name of medicine, other:
  Atrovent CFC-free MDI

Population studied

• Short description of the study population:
  General practitioners (GPs) who issued prescriptions for Atrovent® CFC-free MDI.
• 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)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  13211

Study design details

• Main study objective:
  To actively monitor the safety of the introduction of Atrovent® CFC-free MDI into general practice in England, for both adults and children.
• Data analysis plan:
  Incidence densities for events occurring three months prior to and in the first three months of exposure to Atrovent® CFC-Free MDI were calculated, together with incidence density ratios to compare event rates before and during exposure. A matched analysis of specific events occurring in the three-month before and three-month after exposure period was performed to produce risk ratios.