An open label, multi-centre, post marketing surveillance (PMS) to monitor the safety and efficacy of INCRUSE administered in Korean subjects with chronic obstructive pulmonary disease (COPD) in usual practice (205163)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)

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

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Open-label, single arm, multi-centre post marketing surveillance (PMS). No comparator cohort will be included in this study

Study drug and medical condition

• Name of medicine:
  Incruse
• Study drug International non-proprietary name (INN) or common name:
  UMECLIDINIUM BROMIDE

Population studied

• Short description of the study population:
  Korean subjects with chronic obstructive pulmonary disease (COPD) in usual practice.; ; Inclusion criteria; All subjects must satisfy the following 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 INCRUSE according to locally approved prescribing information; ; Exclusion criteria; - Subject who has medical history of hypersensitivity to the active substances or main substances or atropine derivative(i.e. ipratropium,tiotropium, oxitropium, glycopyrronium, aclidinium); - Subject with severe hypersensitivity to milk proteins; - Subject with hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose 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

  Pregnant women

  Renal impaired
• Estimated number of subjects:
  600

Study design details

• Main study objective:
  To collect safety and effectiveness data of Incruse in Korean COPD patients.
• Outcomes:
  Primary objective is to monitor adverse events, including unexpected adverse events and/or serious adverse events, reported after administrating at least 1 dose of Incruse.- Minimum of one follow-up visit after administration of Incruse in order to assess safety, Secondary objective is to monitor effectiveness after administrating Incruse, as determined by post BD FEV1 on Treatment Week 24.- Minimum 24 weeks follow-up after administrating Incruse for effectiveness
• Data analysis plan:
  Safety analyses will be based on the population, defined as subjects who receive at least one dose of the Incruse and completed at least one safety assessment. In general, data summaries will be presented overall and by the subgroups of interest. Baseline characteristics will be summarized using descriptive statistics.The number and percentage of subjects reporting adverse event after administration of Incruse will be tabulated. Cases with serious adverse events and/or unexpected adverse drug reactions will be described in detail. The distribution of adverse events will be tabulated. The percentage of subjects reporting adverse events will be analyzed using Chi-square test or Fisher’s exact test stratified by potential confounding factors for subgroup analysis.The percentage of subjects reporting adverse events among specific population e,g. the elderly will be tabulated respectively. The difference of the incidence of adverse events by each factor will be analyzed.

Documents

Study results

gsk-205163-clinical-study-report-redact