Non-interventional, cross-sectional, multicenter study to describe the exacerbations profile of COPD patients Treated with ICS in a real-life primary care population in Spain. OPTI Study

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Medical condition to be studied:
  Chronic obstructive pulmonary disease

Population studied

• Short description of the study population:
  Chronic obstructive pulmonary disease (COPD) patients treated with or without ICS in primary care, in Spain.
• Age groups:
  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:
  Chronic obstructive pulmonary disease (COPD) patients
• Estimated number of subjects:
  1000

Study design details

• Main study objective:
  To describe the patient profile for patients treated with ICS at the time of study visit.
• Outcomes:
  The primary outcome is to describe the proportion of patients currently on ICS who did not have moderate/severe exacerbation in the year prior to the study visit. Some of the secondary objectives are:- To describe the patient profile for patients not treated with ICS at the time of study visit- To assess the proportion and the number (count) of patients with COPD treated with ICS at the time of study visit with or without moderate-to-severe exacerbations, both in the previous 1 year and previous 2 years before the study visit.
• Data analysis plan:
  The primary outcome is to describe the proportion of patients currently on ICS who did not have moderate/severe exacerbation in theyear prior to the study visit.Sub-group analysis in the group of patients treated with ICS may be considered according ICS long term use and ICS only for short courses.Since the study is descriptive, the variables included in the study objectives will be summarized overall and by factors of interest. All results will be summarized with measures of central tendency (mean and median), variability/dispersion (standard deviation and interquartile ranges), absolute and relative frequencies, and ranges.The analysis population will consist of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria). If patients have missing values for an outcome, those patients will be excluded for that outcome’s analysis. Missing data will not be imputed.