The effect of flutiform® treatment on asthma control in patients with asthma in daily clinical practice; an observational study

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (R03AK11) formoterol and fluticasone

  formoterol and fluticasone
• 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:
  1200

Study design details

• Main study objective:
  To evaluate the effect of flutiform® treatment with respect to asthma control in patients with asthma in daily clinical practice
• Outcomes:
  The primary efficacy endpoint will be defined as asthma control improvement after 6 months of flutiform® therapy (V3) and this compared to baseline V1. A change or difference in ACQ-score of 0.5 is the smallest that can be considered clinically important. To evaluate the asthma control and the absolute changes in ACQ-scores at each visit compared to baseline. The response to flutiform® therapy will be compared between patients with ICS alone as pre-treatment medication and patients with ICS + LABA as pre-treatment medication
• Data analysis plan:
  Continuous data will be summarized by their mean, standard deviation, 95% confidence interval of the mean, median, minimum and maximum. Categorical and ordinal data will be summarized by frequency and percentages. Where appropriate, 95% confidence intervals will be added.