Validation of the Concept of COPD Control in Clinical Practice

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Other
• If ‘other’, further details on the scope of the study:
  Non-interventional study
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Prospective pragmatic trial

Study drug and medical condition

• Medical condition to be studied:
  Chronic obstructive pulmonary disease

Population studied

• Short description of the study population:
  Patients older than 40 years with a diagnosis of COPD.; Inclusion criteria; Eligible patients must meet the following inclusion criteria, be/have:; 1) Spirometry-defined COPD (i.e. post-bronchodilator FEV1/FVC<0.7); 2) Age ≥40 years; 3) Smokers or ex-smokers of at least 10 pack-years; 4) In stable state (as judged by the investigator) at point of recruitment; Exclusion criteria; Patients will be excluded from the trial if any of the following are true, they:; 1) Have any chronic concomitant respiratory condition other than asthma or bronchiectasis (e.g. cystic fibrosis, lung fibrosis); 2) Have severe comorbidity with a life expectancy shorter than 2 years; 3) Are unable to understand the instructions of the study or to fill the questionnaires; 4) Are unwilling to sign the informed consent; 5) Are participating in another clinical study or clinical trial.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 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:
  328

Study design details

• Main study objective:
  The primary aims of the study will be to evaluate the:1). Levels of COPD control (vs poor COPD control) in an international cohort of routine care COPD patients, and2). The clinical implications of control status
• Outcomes:
  The composite endpoint is defined as occurrence of any of the following:1). For COPD: unscheduled visits to the physician, emergency room attendance2). An exacerbation of COPD3). All-cause: hospitalization or mortality, 1).Annual rate of exacerbations in patients controlled and uncontrolled at baseline2).Time to the first composite event, and time to first exacerbations in patients controlled and uncontrolled at baseline3).Comparison of CAT and CCQ tools to identify impact and stability in COPD4).Distribution of control level in those receiving guideline vs non-guideline recommended therapy5).Demographics
• Data analysis plan:
  Intention-to-treat and per-protocol analyses will be undertaken. For the Intention-to-treat analysis, all patients entered into the study will be included in the analysis. For the per-protocol analysis, all patients entered who complete the study as per protocol (defined as attending baseline and all follow-up visits irrespective) will be included. For variables measured on the interval or ratio scale, these will include:  Sample size (n)  Percentage non-missing  Mean  Variance / Standard Deviation  Range (Minimum / Maximum)  Median  Inter-quartile Range (25th and 75th percentiles)