An open label, multi-centre, post marketing surveillance (PMS) to monitor the safety and effectiveness of ANORO administered in Korean subjects with chronic obstructive pulmonary disease (COPD) in usual practice (204511)

Study type

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

  Safety study (incl. comparative)
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Open-label, single arm, multi-centre post marketing surveillance (PMS)

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  VILANTEROL TRIFENATATE
• Medical condition to be studied:
  Chronic obstructive pulmonary disease

Population studied

• Short description of the study population:
  Patients with chronic obstructive pulmonary disease (COPD) aged 19 years or older received ANORO under usual clinical practice in Korea.; Inclusion criteria: ;  Adult subjects (19 years and older) who have chronic obstructive pulmonary disease (COPD); - Pulmonary Function Test: post bronchodilator, FEV1/FVC < 0.7;  Subjects who will administer ANORO according to locally approved prescribing information; ; Exclusion criteria: ;  Asthma patient;  Subject with acute exacerbation of COPD;  Subject who experienced hypersensitivity to the active substances or to any of the excipients;  Subject with severe hypersensitivity to milk proteins;  Subject with hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
• 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:
  Hepatic impaired

  Other

  Renal impaired
• Special population of interest, other:
  Patients with chronic obstructive pulmonary disease
• Estimated number of subjects:
  3000

Study design details

• Main study objective:
  To collect safety and effectiveness data of Anoro in Korean COPD patients
• Outcomes:
  Incidence of adverse events, incidence of unexpected adverse events and incidence of serious adverse events after administrating ANORO, Effectiveness after administrating ANORO, as determined by post BD FEV1 on Treatment Week 24
• Data analysis plan:
  The number and percentage of subjects with an adverse event, including SAE and/or unexpected AE, after administration of ANORO will be presented. Cases with serious adverse events and/or unexpected adverse drug reactions will be described in detail. The percentage of subjects reporting adverse events will be analyzed using Chi-square test or Fisher’s exact test stratified by potential confounding factors such as gender, age, smoking history, BMI, baseline lung function test(FEV1)before administration, COPD treatment, disease history, exacerbation history and others for subgroup analysis. Effectiveness evaluation will be stratified by potential confounding factors.