A Non interventional post authorisation study to determine the safety and effectiveness of flutiform® (Affirm Study). (FLT9503 AFFIRM)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (R03AK07) formoterol and budesonide

  formoterol and budesonide

  (R03AK07) formoterol and budesonide

  formoterol and budesonide

  (R03AK09) formoterol and mometasone

  formoterol and mometasone
• Medical condition to be studied:
  Asthma

Population studied

• Age groups:
  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:
  2500

Study design details

• Main study objective:
  Evaluation of the safety of flutiform® in routine clinical practice by: Collection of data on the exposure to flutiform® and the frequency of adverse events. Recording all adverse events reported spontaneously or after physicians’ open question by the subjects
• Data analysis plan:
  In general, continuous data will be summarised using the following descriptive statistics: n, mean, standard deviation, median, minimum and maximum. Two sided 95% confidence intervals will be presented around mean values where appropriate. Categorical data will be summarised as the number and percentage of subjects in each category.