WEUSKOP6416: Evaluating severe events in patients with Chronic Obstructive Pulmonary Disease (COPD) to inform risk minimization: A Retrospective Observational Study (116952)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (R03AC) Selective beta-2-adrenoreceptor agonists

  Selective beta-2-adrenoreceptor agonists

  (R03BA) Glucocorticoids

  Glucocorticoids

  (R03BB) Anticholinergics

  Anticholinergics

  (R03CK) Adrenergics and other drugs for obstructive airway diseases

  Adrenergics and other drugs for obstructive airway diseases
• Medical condition to be studied:
  Chronic obstructive pulmonary disease

Population studied

• Short description of the study population:
  Chronic Obstructive Pulmonary Disease (COPD) patients.; Inclusion Criteria; Patients are required to:; 1. Have CPRD-GOLD data of acceptable research quality according to CPRD standards.; 2. Be new users of LABD or ICS-containing medications from January 2002-December 2010; 3. Have a COPD diagnosis at any time in the period prior to and including the Cohort Entry Date (to eliminate any patients with asthma only); 4. Have at least one year of data prior to Cohort Entry Date.; 5. Be at least 45 years of age at Cohort Entry Date.; 6. Have GPRD-HES linkage. (Note: these individuals need to be retained for basic demographics but are not part of the new user cohort).; 7. Have HES coverage one year prior to the Cohort Entry Date; Exclusion Criteria; 1. Patients with an occurrence of a code for a medical condition incompatible with COPD diagnosis any time in their history. This list contains conditions that are a; related to lung or bronchial developmental anomalies, degenerative processes (cystic fibrosis, pulmonary fibrosis), bronchiectasis, pulmonary resection or other significant respiratory disorders other than COPD (but not including cancer) that can interfere with clinical COPD diagnosis or substantially change the natural history of the disease.
• 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:
  18000

Study design details

• Main study objective:
  Any severe pneumonia. Pneumonia that resulted in pneumonia hospitalization or overall mortality during the pneumonia episode. As a sensitivity analysis, hospitalized pneumonia was examined further, as primary cause on any episode within a spell (hospitalization) and as a primary cause on the first episode within a spell.
• Outcomes:
  The primary outcome was severe pneumonia. The secondary outcome was all pneumonias combined, including those that were considered severe and those that were not considered severe.
• Data analysis plan:
  This was a retrospective observational study in the United Kingdom using linked primary and secondary care data with vital statistics. Pneumonia and pneumonia hospitalization events in subjects with COPD were compared in new users defined as an initial prescription of ICS-containing medications (n=11,555, ICS, ICS/LABA combination) and inhaled LABD monotherapies (n=6,492, LABA, LAMA) using Cox models (hazard ratios HR and 95% confidence intervals CI) and propensity scores with inverse proportional treatment weighting (IPTW) to control for confounding. New users were censored at earliest of: pneumonia event, death, switching/stopping treatment, or end of study period. Sensitive and specific pneumonia outcomes were examined including any pneumonia and severe pneumonia resulting in hospitalization or death during the episode. Hospitalized pneumonia was examined further, as primary cause on any episode within a spell and as a primary cause on the first episode within a spell.