The effect of asthma pre-treatment on the efficacy of flutiform® treatment with respect to asthma control in patients with asthma in daily clinical practice; an epidemiologic study. (FLT9502)

Study type

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

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Epidemiologic study

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:
  300

Study design details

• Main study objective:
  To evaluate the effect of asthma pre-treatment on the efficacy of flutiform® treatment with respect to asthma control in patients with asthma in daily clinical practice.
• Outcomes:
  To evaluate the effect of asthma pre-treatment on the efficacy of flutiform® treatment with respect to asthma control in patients with asthma in daily clinical practice. The primary efficacy endpoint will be defined as well controlled asthma (ACQ≤0.75,1) after 12 weeks of flutiform® therapy (V3). To evaluate the ‘ease of use’ of flutiform® treatment To evaluate the effect of flutiform® treatment on daily activities To assess compliance of flutiform® treatment To determine the patient preference of flutiform® treatment compared to previous asthma treatment in daily clinical practice To assess safety of flutiform® treatment
• Data analysis plan:
  General This is an epidemiological study. Descriptive statistics of all efficacy parameters will be provided overall and by previous used asthma medication subgroup (ICS or ICS+LABA). Graphical data analysis will be used to visualize trends over time. Primary efficacy parameter The response on flutiform® treatment (ACQ≤0.75) at Visit 3 will be compared between the two pre-treatment groups, using logistic regression with pre-treatment group, asthma control at baseline and the interaction between pre-treatment and asthma control at baseline as covariates. The odds ratio and relative risk of response for patients pre-treated with ICS only relative to patients pre-treated with ICS and LABA will be presented with 95% confidence intervals. For the calculation of the relative risk modified Poisson regression will be used. Secondary efficacy parameters Asthma Control Ease of useDaily Activities