A prospective, multicentre, non-interventional study to collect further data on the safety and effectiveness of a new combination of formoterol and fluticasone in a pMDI with HFA 227 as the propellant, in subjects with mild to moderate-severe asthma. (FLT9501)

Study type

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

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Non interventional, observational 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:
  4000

Study design details

• Main study objective:
  Evaluation of the safety and effectiveness (efficacy under real life conditions) of flutiform® in patients with asthma in routine clinical practice
• Data analysis plan:
  Continuous data will be summarised by using descriptive statistics – number of patients, mean, standard deviation, median, and range (minimum and maximum). Summary statistics and 95% 2-sided CIs will be used to estimate the effect based on a one sample t-test or ANCOVA especially for the secondary efficacy endpoints FEV1, FVC, FEV1/FVC and PEF. A safety analysis will be performed by descriptive methods on the safety population (SP). All adverse events will be analysed by its causal relationship to flutiform®. The number and percentage of patients reporting adverse events will be summarised by descriptive methods and 95% confidence intervals. In addition, adverse events by severity, adverse events leading to discontinuation of the observed medication and serious adverse events will be summarised. AEs of special interest (e. g. cough, paradoxical bronchospasm, asthma worsening or serious asthma-related events) will beanalysed by descriptive methods and 95% confidence intervals.