Multicenter, open-label, non-interventional study to evaluate the impact on clinical effects, user-friendliness and patient's acceptance of Airflusal® Forspiro® in the treatment of asthma under real life conditions (ASSURE)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product

  Medical device
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Multicenter, open-label, non-interventional study

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (R03AK06) salmeterol and fluticasone

  salmeterol and fluticasone
• Medical condition to be studied:
  Asthma

Population studied

• Short description of the study population:
  Patients with confirmed diagnosis of bronchial asthma and who were being treated with Airflusal® Forspiro®.
• 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Asthma patients
• Estimated number of subjects:
  200

Study design details

• Main study objective:
  To evaluate the impact on clinical effects, user-friendliness and patient's acceptance of Airflusal® Forspiro® in the treatment of asthma under real life conditions.
• Outcomes:
  Primary objectives- To find out about patients' own assessment of the control of their asthma (using the ACT)- To find out about any change in patients' quality of life. Secondary objectives- To assess patients' acceptance of Airflusal® Forspiro® Inhaler- To obtain information about manipulation and user-friendliness of the new Forspiro® inhaler.
• Data analysis plan:
  All statistical evaluations will be descriptive. No confirmatory statistical tests will be performed. Exploratory comparisons of subgroups are planned as are transverse and longitudinal comparisons. P-values of statistical tests are descriptive and do not relate to testing hypotheses.