Evaluation of COPD Control and its Clinical Implications in a Real-Life UK Primary Care Population

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Other
• If ‘other’, further details on the scope of the study:
  Testing the validity/effectiveness of the concept of COPD Control for potential patient management
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Observational, historical database study

Study drug and medical condition

• Medical condition to be studied:
  Chronic obstructive pulmonary disease

Population studied

• Short description of the study population:
  • Patients who have a COPD diagnosis:; o Physician-diagnosed COPD (presence of a COPD Read code); and/or; o Spirometry-defined COPD: post-bronchodilator FEV1/FVC<0.7; • Aged ≥40 years; • Current or ex-smokers; • Recorded COPD Questionnaire data; • ≥3 months’ continuous clinical records immediately prior to the index date; • ≥1 year of continuous clinical records immediately following the index date
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 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:
  300

Study design details

• Main study objective:
  The purpose of this study is to validate the concept of Control in COPD, as outlined in Soler- Cataluna et al. 2014. First, COPD patients treated in UK routine primary care will be characterised in terms or their control. Second, we will evaluate the clinical implications of control status in terms of COPD treatment management.
• Outcomes:
  The primary endpoint of the study is the difference between patients controlled vs uncontrolled at baseline / index date in terms of:a) Time to first COPD exacerbationb) Exacerbation rate over the 1-year outcome period, Secondary endpoints1. Annual rate of COPD exacerbations in patients controlled vs non-controlled at index date.2. Time to the first exacerbation in patients controlled and non controlled at baseline3. Demographic and clinical characteristics associated with poor COPD control, specifically:(a) Age(b) Sex(c) Height(d) Weight(e) Therapy (f) Airway obstruction(g) Smoking history
• Data analysis plan:
  Statistically significant results will be defined as p<0.05 and trends as 0.05≤p<0.10. Association between COPD control status and the outcome period will be modeled using appropriate statistical methods. The statistical approach to be outlined in the statistical analysis plan (SAP) and will be approved by the lead investigator before the study commences.To evaluate the interaction of different patient (clinical and demographic) characteristics on the association between control status and outcomes, results will be stratified by:• Age• Sex• Height• Weight• Therapy (at index date)• Airway obstruction• Smoking history (pack years)